The effectiveness of a single dose of peg-filgrastim (PD-Lasta) compared with Filgrastim (PD-grastim) to increase the absolute number of neutrophils (ANC) in patients with AML after chemotherapy
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Protocol summary
Objective: The purpose of this clinical trial is comparing the effect of peg-filgrastim (PD-Lasta) with filgrastim (PD-grastim) in increasing neutrophils in AML patients after chemotherapy. Design & Setting: 58 patients with AML after one or two courses of induction chemotherapy (cytarabine + daunorubicin) and after achieving remission, undergoes consolidation with high-dose cytarabine (4 courses). Patients are divided into two groups via Haphazard number table. The first group 24 hours after consolidation chemotherapy receive daily subcutaneous PD-grastim 5 μgr/kg dose and the second group 24 hours after consolidation chemotherapy receive a PD-Lasta 6mg dose. Then daily ANC (absolute neutrophil count) of the patients in two groups are recorded until reaching above 1500 per microlitre. Participants: All patients between 15 to 65 years old with AML who are in remission following induction chemotherapy after receiving high-dose cytarabine enter the trial and if any patient is suffering from sepsis is removed from the trial. Main outcome measures: The primary outcome: The effect of PD-Lasta usage in increasing patients ANC above 1500/ul. Secondary outcomes: The effect of PD-Lasta usage in reducing the incidence of infection after chemotherapy.
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Objective: The purpose of this clinical trial is comparing the effect of peg-filgrastim (PD-Lasta) with filgrastim (PD-grastim) in increasing neutrophils in AML patients after chemotherapy. Design & Setting: 58 patients with AML after one or two courses of induction chemotherapy (cytarabine + daunorubicin) and after achieving remission, undergoes consolidation with high-dose cytarabine (4 courses). Patients are divided into two groups via Haphazard number table. The first group 24 hours after consolidation chemotherapy receive daily subcutaneous PD-grastim 5 μgr/kg dose and the second group 24 hours after consolidation chemotherapy receive a PD-Lasta 6mg dose. Then daily ANC (absolute neutrophil count) of the patients in two groups are recorded until reaching above 1500 per microlitre. Participants: All patients between 15 to 65 years old with AML who are in remission following induction chemotherapy after receiving high-dose cytarabine enter the trial and if any patient is suffering from sepsis is removed from the trial. Main outcome measures: The primary outcome: The effect of PD-Lasta usage in increasing patients ANC above 1500/ul. Secondary outcomes: The effect of PD-Lasta usage in reducing the incidence of infection after chemotherapy.
اهداف: هدف این کارآزمایی بالینی مقایسه اثر(PD-Lasta) peg-filgrastim با
PD-filgrastim) filgrastim) در افزایش نوتروفیل بیماران AML پس از شیمی درمانی می باشد. طراحی و نحوه انجام: 58 بیمار مبتلا به AML پس از دریافت یک یا دو کورس شیمی درمانی القایی (سیتارابین+دانوروبیسین) و پس از رفتن به رمیسیون، تحت درمان با سیتارابین با دوز بالا (چهار سیکل) قرار می گیرند. سپس با استفاده از جدول اعداد تصادفی به دو گروه تقسیم می شوند. گروه اول 24 ساعت پس از اتمام هر سیکل شیمی درمانی تحکیمی، روزانه PD-grastim بادوز 5 میکرو گرم برای هر کیلوگرم زیر جلدی در یافت می کنند و گروه دوم 24 ساعت پس از اتمام شیمی درمانی تحکیمی یک دوز 6 میلی گرم PD-lasta دریافت می کنند. سپس به طور روزانهabsolute neutrophil count (ANC) بیماران در هر دو گروه ثبت می شود تا زمانی که ANC به بالای 1500 در میکرو لیتر برسد. شرکت کنندگان: تمام بیماران 15 تا 65 سال مبتلا به AML که تحت شیمی درمانی القایی به رمیسیون رفته اند پس از دریافت سیتارابین با دوز بالا وارد این کارآزمایی می شوند و چنانچه بیماری دچار سپسیس شود از کارآزمایی خارج می شود. متغیرهای پیامد اصلی: پیامد اولیه: تأثیر استفاده از PD-Lasta در افزایش نوتروفیل بیماران مبتلا به AML به بالای 1500 در میکرولیتر. پیامد ثانویه: تأثیر استفاده از PD-Lasta در کاهش بروز عفونت پس از شیمی درمانی.
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اهداف: هدف این کارآزمایی بالینی مقایسه اثر(PD-Lasta) peg-filgrastim با PD-filgrastim) filgrastim) در افزایش نوتروفیل بیماران AML پس از شیمی درمانی می باشد. طراحی و نحوه انجام: 58 بیمار مبتلا به AML پس از دریافت یک یا دو کورس شیمی درمانی القایی (سیتارابین+دانوروبیسین) و پس از رفتن به رمیسیون، تحت درمان با سیتارابین با دوز بالا (چهار سیکل) قرار می گیرند. سپس با استفاده از جدول اعداد تصادفی به دو گروه تقسیم می شوند. گروه اول 24 ساعت پس از اتمام هر سیکل شیمی درمانی تحکیمی، روزانه PD-grastim بادوز 5 میکرو گرم برای هر کیلوگرم زیر جلدی در یافت می کنند و گروه دوم 24 ساعت پس از اتمام شیمی درمانی تحکیمی یک دوز 6 میلی گرم PD-lasta دریافت می کنند. سپس به طور روزانهabsolute neutrophil count (ANC) بیماران در هر دو گروه ثبت می شود تا زمانی که ANC به بالای 1500 در میکرو لیتر برسد. شرکت کنندگان: تمام بیماران 15 تا 65 سال مبتلا به AML که تحت شیمی درمانی القایی به رمیسیون رفته اند پس از دریافت سیتارابین با دوز بالا وارد این کارآزمایی می شوند و چنانچه بیماری دچار سپسیس شود از کارآزمایی خارج می شود. متغیرهای پیامد اصلی: پیامد اولیه: تأثیر استفاده از PD-Lasta در افزایش نوتروفیل بیماران مبتلا به AML به بالای 1500 در میکرولیتر. پیامد ثانویه: تأثیر استفاده از PD-Lasta در کاهش بروز عفونت پس از شیمی درمانی.
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comparing the effect of peg-filgrastim (PD-Lasta) with filgrastim (PD-grastim) in increasing neutrophils in AML patients after chemotherapy.
comparing the effect of peg-filgrastim (PD-Lasta) with filgrastim (PD-grastim) in increasing neutrophils in AML patients after chemotherapy.
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مقایسه اثر(PD-Lasta) peg-filgrastim با PD-filgrastim) filgrastim) در افزایش نوتروفیل بیماران AML پس از شیمی درمانی می باشد.
مقایسه اثر(PD-Lasta) peg-filgrastim با PD-filgrastim) filgrastim) در افزایش نوتروفیل بیماران AML پس از شیمی درمانی می باشد.
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58 patients with AML after one or two courses of induction chemotherapy (cytarabine + daunorubicin) and after achieving remission, undergoes consolidation with high-dose cytarabine (4 courses). Patients are divided into two groups via Haphazard number table. The first group 24 hours after consolidation chemotherapy receive daily subcutaneous PD-grastim 5 μgr/kg dose and the second group 24 hours after consolidation chemotherapy receive a PD-Lasta 6mg dose. Then daily ANC (absolute neutrophil count) of the patients in two groups are recorded until reaching above 1500 per microlitre.
58 patients with AML after one or two courses of induction chemotherapy (cytarabine + daunorubicin) and after achieving remission, undergoes consolidation with high-dose cytarabine (4 courses). Patients are divided into two groups via Haphazard number table. The first group 24 hours after consolidation chemotherapy receive daily subcutaneous PD-grastim 5 μgr/kg dose and the second group 24 hours after consolidation chemotherapy receive a PD-Lasta 6mg dose. Then daily ANC (absolute neutrophil count) of the patients in two groups are recorded until reaching above 1500 per microlitre.
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58 بیمار مبتلا به AML پس از دریافت یک یا دو کورس شیمی درمانی القایی (سیتارابین+دانوروبیسین) و پس از رفتن به رمیسیون، تحت درمان با سیتارابین با دوز بالا (چهار سیکل) قرار می گیرند. سپس با استفاده از جدول اعداد تصادفی به دو گروه تقسیم می شوند. گروه اول 24 ساعت پس از اتمام هر سیکل شیمی درمانی تحکیمی، روزانه PD-grastim بادوز 5 میکرو گرم برای هر کیلوگرم زیر جلدی در یافت می کنند و گروه دوم 24 ساعت پس از اتمام شیمی درمانی تحکیمی یک دوز 6 میلی گرم PD-lasta دریافت می کنند. سپس به طور روزانهabsolute neutrophil count (ANC) بیماران در هر دو گروه ثبت می شود تا زمانی که ANC به بالای 1500 در میکرو لیتر برسد.
58 بیمار مبتلا به AML پس از دریافت یک یا دو کورس شیمی درمانی القایی (سیتارابین+دانوروبیسین) و پس از رفتن به رمیسیون، تحت درمان با سیتارابین با دوز بالا (چهار سیکل) قرار می گیرند. سپس با استفاده از جدول اعداد تصادفی به دو گروه تقسیم می شوند. گروه اول 24 ساعت پس از اتمام هر سیکل شیمی درمانی تحکیمی، روزانه PD-grastim بادوز 5 میکرو گرم برای هر کیلوگرم زیر جلدی در یافت می کنند و گروه دوم 24 ساعت پس از اتمام شیمی درمانی تحکیمی یک دوز 6 میلی گرم PD-lasta دریافت می کنند. سپس به طور روزانهabsolute neutrophil count (ANC) بیماران در هر دو گروه ثبت می شود تا زمانی که ANC به بالای 1500 در میکرو لیتر برسد.
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The Data were collected by taking a daily questionnaire and a daily CBC test and measuring the absolute neutrophil count for each patient in case of neutropenia (ANC≤1.5×109/L).
The Data were collected by taking a daily questionnaire and a daily CBC test and measuring the absolute neutrophil count for each patient in case of neutropenia (ANC≤1.5×109/L).
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اطلاعات از طریق پرسشنامه و مشاهده لام خون محیطی و ثبت تعداد نوتروفیل های بیماران (ANC≤1.5×109/L) و همچنینت معاینه روزانه بیماران از نظر بروز عوارض دارویی جمع آوری شد.
اطلاعات از طریق پرسشنامه و مشاهده لام خون محیطی و ثبت تعداد نوتروفیل های بیماران (ANC≤1.5×109/L) و همچنینت معاینه روزانه بیماران از نظر بروز عوارض دارویی جمع آوری شد.
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All patients between 15 to 65 years old with AML who are in remission following induction chemotherapy after receiving high-dose cytarabine enter the trial and if any patient is suffering from sepsis is removed from the trial.
All patients between 15 to 65 years old with AML who are in remission following induction chemotherapy after receiving high-dose cytarabine enter the trial and if any patient is suffering from sepsis is removed from the trial.
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تمام بیماران 15 تا 65 سال مبتلا به AML که تحت شیمی درمانی القایی به رمیسیون رفته اند پس از دریافت سیتارابین با دوز بالا وارد این کارآزمایی می شوند و چنانچه بیماری دچار سپسیس شود از کارآزمایی خارج می شود.
تمام بیماران 15 تا 65 سال مبتلا به AML که تحت شیمی درمانی القایی به رمیسیون رفته اند پس از دریافت سیتارابین با دوز بالا وارد این کارآزمایی می شوند و چنانچه بیماری دچار سپسیس شود از کارآزمایی خارج می شود.
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The first group 24 hours after consolidation chemotherapy receive daily subcutaneous PD-grastim 5 μgr/kg dose and the second group 24 hours after consolidation chemotherapy receive a PD-Lasta 6mg dose.
The first group 24 hours after consolidation chemotherapy receive daily subcutaneous PD-grastim 5 μgr/kg dose and the second group 24 hours after consolidation chemotherapy receive a PD-Lasta 6mg dose.
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گروه اول 24 ساعت پس از اتمام هر سیکل شیمی درمانی تحکیمی، روزانه PD-grastim بادوز 5 میکرو گرم برای هر کیلوگرم زیر جلدی در یافت می کنند و گروه دوم 24 ساعت پس از اتمام شیمی درمانی تحکیمی یک دوز 6 میلی گرم PD-lasta دریافت می کنند.
گروه اول 24 ساعت پس از اتمام هر سیکل شیمی درمانی تحکیمی، روزانه PD-grastim بادوز 5 میکرو گرم برای هر کیلوگرم زیر جلدی در یافت می کنند و گروه دوم 24 ساعت پس از اتمام شیمی درمانی تحکیمی یک دوز 6 میلی گرم PD-lasta دریافت می کنند.
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Main outcome measures: The primary outcome: The effect of PD-Lasta usage in increasing patients ANC above 1500/ul. Secondary outcomes: The effect of PD-Lasta usage in reducing the incidence of infection after chemotherapy.
Main outcome measures: The primary outcome: The effect of PD-Lasta usage in increasing patients ANC above 1500/ul. Secondary outcomes: The effect of PD-Lasta usage in reducing the incidence of infection after chemotherapy.
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متغیرهای پیامد اصلی: پیامد اولیه: تأثیر استفاده از PD-Lasta در افزایش نوتروفیل بیماران مبتلا به AML به بالای 1500 در میکرولیتر. پیامد ثانویه: تأثیر استفاده از PD-Lasta در کاهش بروز عفونت پس از شیمی درمانی.
متغیرهای پیامد اصلی: پیامد اولیه: تأثیر استفاده از PD-Lasta در افزایش نوتروفیل بیماران مبتلا به AML به بالای 1500 در میکرولیتر. پیامد ثانویه: تأثیر استفاده از PD-Lasta در کاهش بروز عفونت پس از شیمی درمانی.
General information
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2015-07-29, 1394/05/07
2015-07-29 00:00:00
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2016-02-09, 1394/11/20
2016-02-09 00:00:00
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2017-07-11, 1396/04/20
2017-07-11 00:00:00
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To Submit the Final Report
To Submit the Final Report
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Denovo AML
Age 15-65
Achieved complete remission after induction chemotherapy
Received high dose of Cytarabine in consolidation chemotherapy
Denovo AML Age 15-65 Achieved complete remission after induction chemotherapy Received high dose of Cytarabine in consolidation chemotherapy
لوسمی میلوییدی اولیه ( Denovo AML )
سن 15تا 65 ساله
بعد از شیمی درمانی القایی به رمیسیون رفته باشند
تحت شیمی درمانی تحکیمی با سیتارابین با دوز بالا قرار گرفته باشند.
لوسمی میلوییدی اولیه ( Denovo AML ) سن 15تا 65 ساله بعد از شیمی درمانی القایی به رمیسیون رفته باشند تحت شیمی درمانی تحکیمی با سیتارابین با دوز بالا قرار گرفته باشند.
Secondary AML
ECOG performance status≥3
Have any effective disease (such as cardiovascular disease, renal disease, liver disease, pulmonary disease, diabetes, high blood pressure etc.) or receiving drugs and continuous treatment
Secondary AML ECOG performance status≥3 Have any effective disease (such as cardiovascular disease, renal disease, liver disease, pulmonary disease, diabetes, high blood pressure etc.) or receiving drugs and continuous treatment
AML ثانویه
عملکرد 3 ≥ECOG
بیماران فاقد بیماری های همراه تاثیرگذار (شامل بیماری های شناخته شده قلبی عروقی ، کلیوی ، کبدی , ریوی , دیابت , فشارخون , . . .که در حال دریافت دارو و درمان های مستمر می باشند.)
AML ثانویه عملکرد 3 ≥ECOG بیماران فاقد بیماری های همراه تاثیرگذار (شامل بیماری های شناخته شده قلبی عروقی ، کلیوی ، کبدی , ریوی , دیابت , فشارخون , . . .که در حال دریافت دارو و درمان های مستمر می باشند.)
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with 6 patients block randomized to two classes of the drugs
with 6 patients block randomized to two classes of the drugs
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با استفاده از بلوک های شش تایی عضویت بیمار به گروه های مربوطه (نوع داروی تجویزی) قبل از شروع مطالعه مشخص شد.
با استفاده از بلوک های شش تایی عضویت بیمار به گروه های مربوطه (نوع داروی تجویزی) قبل از شروع مطالعه مشخص شد.
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AML patients were blindly allocated to short acting and long acting group receiving short acting and long acting G-CSF respetively
AML patients were blindly allocated to short acting and long acting group receiving short acting and long acting G-CSF respetively
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بیماران AML بعداز رسیدن به رمیسیون با سیتارابین و دانوروبیسین بطور تصادفی به دو گروه تقسیم و محرک رشد گلبول سفید کوتاه و طولانی مدت دریافت کردند
بیماران AML بعداز رسیدن به رمیسیون با سیتارابین و دانوروبیسین بطور تصادفی به دو گروه تقسیم و محرک رشد گلبول سفید کوتاه و طولانی مدت دریافت کردند
58 individual/event
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58 individual/event
58 نفر/ حادثه
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58 نفر/ حادثه
Recruitment centers
#1
Name of recruitment center - English: Hematology Oncology ward of Valiasr Hospital, Imama Khomeini Hospital Complex
Name of recruitment center - Persian: بخش هماتولوژی انکولوژی بیمارستان ولی عصر (عج) مجتمع بیمارستان امام خمینی (ره)
Full name of responsible person - English: Dr Mohsen Esfandbod
Full name of responsible person - Persian: دکتر محسن اسفندبد
Street address - English: Valiasr Hospital of Imam Khomeini hospital complex, Gharib Street, End of the Keshavarz Boulevard
Street address - Persian: انتهای بلوار کشاورز، خیابان دکتر قریب، مجتمع بیمارستانی امام خمینی (ره)، بیمارستان ولی عصر (عج)
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Hematology Oncology ward of Valiasr Hospital, Imama Khomeini Hospital Complex
Name of recruitment center - Persian: بخش هماتولوژی انکولوژی بیمارستان ولی عصر (عج) مجتمع بیمارستان امام خمینی (ره)
Full name of responsible person - English: Dr Mohsen Esfandbod
Full name of responsible person - Persian: دکتر محسن اسفندبد
Street address - English: Valiasr Hospital of Imam Khomeini hospital complex, Gharib Street, End of the Keshavarz Boulevard
Street address - Persian: انتهای بلوار کشاورز، خیابان دکتر قریب، مجتمع بیمارستانی امام خمینی (ره)، بیمارستان ولی عصر (عج)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419733141
Phone: +98 21 6658 1593
Fax:
Email: sfandbod@sina.tums.ac.ir
Web page address:
Name of recruitment center - English: Hematology Oncology ward of Valiasr Hospital, Imama Khomeini Hospital Complex Name of recruitment center - Persian: بخش هماتولوژی انکولوژی بیمارستان ولی عصر (عج) مجتمع بیمارستان امام خمینی (ره) Full name of responsible person - English: Dr Mohsen Esfandbod Full name of responsible person - Persian: دکتر محسن اسفندبد Street address - English: Valiasr Hospital of Imam Khomeini hospital complex, Gharib Street, End of the Keshavarz Boulevard Street address - Persian: انتهای بلوار کشاورز، خیابان دکتر قریب، مجتمع بیمارستانی امام خمینی (ره)، بیمارستان ولی عصر (عج) City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1419733141 Phone: +98 21 6658 1593 Fax: Email: sfandbod@sina.tums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Pooyesh Darou Biopharmaceutical Company
Name of organization / entity - Persian: شرکت پویش دارو
Full name of responsible person - English: Shima Tanha
Full name of responsible person - Persian: شیما تنها
Street address - English: No.13, 5th Ave, Fatemi St, Tehran, Iran
Street address - Persian: تهران- خیابان فاطمی- خیابان پنجم- پلاک 13
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Pooyesh Darou Biopharmaceutical Company
Name of organization / entity - Persian: شرکت پویش دارو
Full name of responsible person - English: Shima Tanha
Full name of responsible person - Persian: شیما تنها
Street address - English: No.13, 5th Ave, Fatemi St, Tehran, Iran
Street address - Persian: تهران- خیابان فاطمی- خیابان پنجم- پلاک 13
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1415763863
Phone: +98 21 8897 0979
Fax:
Email: info@pooyeshdarou.com
Web page address:
contact.organization_id: Name of organization / entity - English: Pooyesh Darou Biopharmaceutical Company Name of organization / entity - Persian: شرکت پویش دارو Full name of responsible person - English: Shima Tanha Full name of responsible person - Persian: شیما تنها Street address - English: No.13, 5th Ave, Fatemi St, Tehran, Iran Street address - Persian: تهران- خیابان فاطمی- خیابان پنجم- پلاک 13 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1415763863 Phone: +98 21 8897 0979 Fax: Email: info@pooyeshdarou.com Web page address:
empty
Private
private
empty
Domestic
domestic
empty
Persons
persons
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Dr Mohsen Esfandbod
Full name of responsible person - Persian: دکتر محسن اسفندبد
Position - English: Adult clinical Hematology Oncology/ Assistant Professor
Position - Persian: فوق تخصص خون و سرطان بالغین/استادیار هیأت علمی دانشگاه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Keshavarz Boulevard, Cornre of the Ghods Street
Street address - Persian: بلوار کشاورز، نبش خیابان قدس
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 81631
Mobile: +98 912 113 7334
Fax: +98 21 8898 9664
Email: sfandbod@sina.tums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Dr Mohsen Esfandbod
Full name of responsible person - Persian: دکتر محسن اسفندبد
Position - English: Adult clinical Hematology Oncology/ Assistant Professor
Position - Persian: فوق تخصص خون و سرطان بالغین/استادیار هیأت علمی دانشگاه
Latest degree: sub_specialist
Area of specialty/work: 88
Area of specialty/work title - English: adult clinical hematologist oncologist
Area of specialty/work title - Persian: خون و سرطان بالغین
Street address - English: Keshavarz Boulevard, Cornre of the Ghods Street
Street address - Persian: بلوار کشاورز، نبش خیابان قدس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 81631
Mobile: +98 912 113 7334
Fax: +98 21 8898 9664
Email: sfandbod@sina.tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tehran University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران Full name of responsible person - English: Dr Mohsen Esfandbod Full name of responsible person - Persian: دکتر محسن اسفندبد Position - English: Adult clinical Hematology Oncology/ Assistant Professor Position - Persian: فوق تخصص خون و سرطان بالغین/استادیار هیأت علمی دانشگاه Latest degree: sub_specialist Area of specialty/work: 088 Area of specialty/work title - English: adult clinical hematologist oncologist Area of specialty/work title - Persian: خون و سرطان بالغین Street address - English: Keshavarz Boulevard, Cornre of the Ghods Street Street address - Persian: بلوار کشاورز، نبش خیابان قدس City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1417653761 Phone: +98 21 81631 Mobile: +98 912 113 7334 Fax: +98 21 8898 9664 Email: sfandbod@sina.tums.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Dr Gholamreza Toogeh
Full name of responsible person - Persian: دکتر غلامرضا توگه
Position - English: Adult clinical Hematology Oncology/ Associate Professor
Position - Persian: فوق تخصص خون و سرطان بالغین/دانشیار هیأت علمی دانشگاه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Keshavarz Boulevard, Cornre of the Ghods Street
Street address - Persian: بلوار کشاورز، نبش خیابان قدس
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 81631
Mobile: +98 912 134 6329
Fax: +98 21 8898 9664
Email: gh_toogeh@yahoo.com; togehgho@sina.tums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Dr Gholamreza Toogeh
Full name of responsible person - Persian: دکتر غلامرضا توگه
Position - English: Adult clinical Hematology Oncology/ Associate Professor
Position - Persian: فوق تخصص خون و سرطان بالغین/دانشیار هیأت علمی دانشگاه
Latest degree: sub_specialist
Area of specialty/work: 0
Area of specialty/work title - English: adult clinical hematologist oncologist
Area of specialty/work title - Persian: فوق تخصص خون و سرطان بالغین
Street address - English: Keshavarz Boulevard, Cornre of the Ghods Street
Street address - Persian: بلوار کشاورز، نبش خیابان قدس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 81631
Mobile: +98 912 134 6329
Fax: +98 21 8898 9664
Email: gh_toogeh@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Tehran University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران Full name of responsible person - English: Dr Gholamreza Toogeh Full name of responsible person - Persian: دکتر غلامرضا توگه Position - English: Adult clinical Hematology Oncology/ Associate Professor Position - Persian: فوق تخصص خون و سرطان بالغین/دانشیار هیأت علمی دانشگاه Latest degree: sub_specialist Area of specialty/work: 0 Area of specialty/work title - English: adult clinical hematologist oncologist Area of specialty/work title - Persian: فوق تخصص خون و سرطان بالغین Street address - English: Keshavarz Boulevard, Cornre of the Ghods Street Street address - Persian: بلوار کشاورز، نبش خیابان قدس City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1417653761 Phone: +98 21 81631 Mobile: +98 912 134 6329 Fax: +98 21 8898 9664 Email: gh_toogeh@yahoo.com; togehgho@sina.tums.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Fariba Zarrabi
Full name of responsible person - Persian: فریبا ضرابی
Position - English: Research Administrate at Thrombosis Hemostasis Research Center/ MSc in Genetics
Position - Persian: کارشناسی ارشد رشته ژنتیک
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Keshavarz Boulevard, Cornre of the Ghods Street
Street address - Persian: بلوار کشاورز، نبش خیابان قدس
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 81631
Mobile: +98 912 539 5986
Fax: +98 21 8898 9664
Email: fariba_zarrabi@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Fariba Zarrabi
Full name of responsible person - Persian: فریبا ضرابی
Position - English: Research Administrate at Thrombosis Hemostasis Research Center/ MSc in Genetics
Position - Persian: کارشناسی ارشد رشته ژنتیک
Latest degree: master
Area of specialty/work: 51
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Keshavarz Boulevard, Cornre of the Ghods Street
Street address - Persian: بلوار کشاورز، نبش خیابان قدس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 81631
Mobile: +98 912 539 5986
Fax: +98 21 8898 9664
Email: fariba_zarrabi@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Tehran University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران Full name of responsible person - English: Fariba Zarrabi Full name of responsible person - Persian: فریبا ضرابی Position - English: Research Administrate at Thrombosis Hemostasis Research Center/ MSc in Genetics Position - Persian: کارشناسی ارشد رشته ژنتیک Latest degree: master Area of specialty/work: 051 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Keshavarz Boulevard, Cornre of the Ghods Street Street address - Persian: بلوار کشاورز، نبش خیابان قدس City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1417653761 Phone: +98 21 81631 Mobile: +98 912 539 5986 Fax: +98 21 8898 9664 Email: fariba_zarrabi@yahoo.com Web page address:
Sharing plan
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
na
na
na
na
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comparison of long acting and short acting G-CSF in neutrophil recovery in AML patients after consolidation
comparison of long acting and short acting G-CSF in neutrophil recovery in AML patients after consolidation
empty
مقایسه محرک رشد گلبول قرمز کوتاه و طولانی اثر در بیماران لوسمی حاد میلوییدی پس از درمان تحکیمی
مقایسه محرک رشد گلبول قرمز کوتاه و طولانی اثر در بیماران لوسمی حاد میلوییدی پس از درمان تحکیمی
*Cytogenetic data were not available in five patients.
Characteristic
PD-Grastim(n=22)
PD-Lasta(n=29)
Age, years
Mean (SD)
46.5 (14.1)
42.3 (13.3)
Range
15-65
15-65
Sex, n (%)
Male
10 (41.4)
24 (82.8)
Female
12 (58.6)
5 (17.2)
*Cytogenetic, n
Intermediate
14
24
Favorable
3
4
Unfavorable
1
-
*Cytogenetic data were not available in five patients.
اطلاعات پایه
PD-Grastim(n=22)
PD-Lasta(n=29)
سن، سال
Mean (SD)
46.5 (14.1)
42.3 (13.3)
Range
15-65
15-65
جنسیت, n (%)
مرد
10 (41.4)
24 (82.8)
زن
12 (58.6)
5 (17.2)
*سایتوژنتیک, n
Intermediate
14
24
Favorable
3
4
Unfavorable
1
-
*Cytogenetic data were not available in five patients.
اطلاعات پایه
PD-Grastim(n=22)
PD-Lasta(n=29)
سن، سال
Mean (SD)
46.5 (14.1)
42.3 (13.3)
Range
15-65
15-65
جنسیت, n (%)
مرد
10 (41.4)
24 (82.8)
زن
12 (58.6)
5 (17.2)
*سایتوژنتیک, n
Intermediate
14
24
Favorable
3
4
Unfavorable
1
-
*Cytogenetic data were not available in five patients.
Inclusion criteria
Exclusion criteria
Age 15-65
Secondary AML
Denovo AML
ECOG performance status≥3
Achieved complete remission after induction chemotherapy
Have any effective disease (such as cardiovascular disease, renal disease, liver disease, pulmonary disease, diabetes, high blood pressure etc.) or receiving drugs and continuous treatment
Received high dose of Cytarabine in consolidation chemotherapy
Inclusion criteria
Exclusion criteria
Age 15-65
Secondary AML
Denovo AML
ECOG performance status≥3
Achieved complete remission after induction chemotherapy
Have any effective disease (such as cardiovascular disease, renal disease, liver disease, pulmonary disease, diabetes, high blood pressure etc.) or receiving drugs and continuous treatment
Received high dose of Cytarabine in consolidation chemotherapy
معیار ورود
معیار خروج
سن 15-65
ثانویه AML
Denovo AML
ECOG performance status≥3
رسیدن به بهبود کامل بعد از شیمی درمانی
داشتن بیماری تأثیرگذار (مثل بیماری های قلب، کلیه، کبد، ریه، دیابت، فشار خون بالا و غیره و یا گرفتن داروها و درمان های مداوم)
گرفتن دوز بالای Cytarabine در consolidation chemotherapy
معیار ورود
معیار خروج
سن 15-65
ثانویه AML
Denovo AML
ECOG performance status≥3
رسیدن به بهبود کامل بعد از شیمی درمانی
داشتن بیماری تأثیرگذار (مثل بیماری های قلب، کلیه، کبد، ریه، دیابت، فشار خون بالا و غیره و یا گرفتن داروها و درمان های مداوم)
گرفتن دوز بالای Cytarabine در consolidation chemotherapy
Complication
PD-Grastim(n=22)
PD-Lasta(n=29)
Fever, n (%)
3 (13.6%)
3 (10.3%)
Bone pain, n (%)
13 (59.1%)
12 (41.4%)
Fatigue, n (%)
1 ( 3.4% )
1 (3.4%)
Headache, n (%)
1 (3.4%)
1 (3.4%)
Complication
PD-Grastim(n=22)
PD-Lasta(n=29)
Fever, n (%)
3 (13.6%)
3 (10.3%)
Bone pain, n (%)
13 (59.1%)
12 (41.4%)
Fatigue, n (%)
1 ( 3.4% )
1 (3.4%)
Headache, n (%)
1 (3.4%)
1 (3.4%)
رخدادهای نامطلوب
PD-Grastim(n=22)
PD-Lasta(n=29)
تب,n (%)
3 (13.6%)
3 (10.3%)
درد استخوان,n (%)
13 (59.1%)
12 (41.4%)
خستگی,n (%)
1 ( 3.4% )
1 (3.4%)
سردرد,n (%)
1 (3.4%)
1 (3.4%)
رخدادهای نامطلوب
PD-Grastim(n=22)
PD-Lasta(n=29)
تب,n (%)
3 (13.6%)
3 (10.3%)
درد استخوان,n (%)
13 (59.1%)
12 (41.4%)
خستگی,n (%)
1 ( 3.4% )
1 (3.4%)
سردرد,n (%)
1 (3.4%)
1 (3.4%)
empty
The median time to recovery of neutrophils was 11.00 and 13.00 days for short-acting G-CSF (PD-Grastim) (n=22) and long-acting G-CSF (PD-Lasta) (n=29) groups, respectively (U=186.5, P>0.05 two-tailed). The incidence of adverse effects was similar in both short-acting G-CSF (PD-Grastim) and long-acting G-CSF (PD-Lasta) groups.
The median time to recovery of neutrophils was 11.00 and 13.00 days for short-acting G-CSF (PD-Grastim) (n=22) and long-acting G-CSF (PD-Lasta) (n=29) groups, respectively (U=186.5, P>0.05 two-tailed). The incidence of adverse effects was similar in both short-acting G-CSF (PD-Grastim) and long-acting G-CSF (PD-Lasta) groups.
empty
میانه زمان در بهبود نوتروفیل ها به ترتیب 11.00 و 13.00 روز برای گروه های short-acting G-CSF (PD-Grastim) (n=22) و long-acting G-CSF (PD-Lasta) (n=29) بود (U=186.5, P>0.05 two-tailed). وقوع رخدادهای نامطلوب در هر دو گروه مشابه بود.
میانه زمان در بهبود نوتروفیل ها به ترتیب 11.00 و 13.00 روز برای گروه های short-acting G-CSF (PD-Grastim) (n=22) و long-acting G-CSF (PD-Lasta) (n=29) بود (U=186.5, P>0.05 two-tailed). وقوع رخدادهای نامطلوب در هر دو گروه مشابه بود.
Protocol summary
Study aim
comparing the effect of peg-filgrastim (PD-Lasta) with filgrastim (PD-grastim) in increasing neutrophils in AML patients after chemotherapy.
Design
58 patients with AML after one or two courses of induction chemotherapy (cytarabine + daunorubicin) and after achieving remission, undergoes consolidation with high-dose cytarabine (4 courses). Patients are divided into two groups via Haphazard number table. The first group 24 hours after consolidation chemotherapy receive daily subcutaneous PD-grastim 5 μgr/kg dose and the second group 24 hours after consolidation chemotherapy receive a PD-Lasta 6mg dose. Then daily ANC (absolute neutrophil count) of the patients in two groups are recorded until reaching above 1500 per microlitre.
Settings and conduct
The Data were collected by taking a daily questionnaire and a daily CBC test and measuring the absolute neutrophil count for each patient in case of neutropenia (ANC≤1.5×109/L).
Participants/Inclusion and exclusion criteria
All patients between 15 to 65 years old with AML who are in remission following induction chemotherapy after receiving high-dose cytarabine enter the trial and if any patient is suffering from sepsis is removed from the trial.
Intervention groups
The first group 24 hours after consolidation chemotherapy receive daily subcutaneous PD-grastim 5 μgr/kg dose and the second group 24 hours after consolidation chemotherapy receive a PD-Lasta 6mg dose.
Main outcome variables
Main outcome measures: The primary outcome: The effect of PD-Lasta usage in increasing patients ANC above 1500/ul. Secondary outcomes: The effect of PD-Lasta usage in reducing the incidence of infection after chemotherapy.
General information
Reason for update
To Submit the Final Report
Acronym
none
IRCT registration information
IRCT registration number:IRCT2015072623349N1
Registration date:2016-01-19, 1394/10/29
Registration timing:registered_while_recruiting
Last update:2022-06-27, 1401/04/06
Update count:1
Registration date
2016-01-19, 1394/10/29
Registrant information
Name
Mohsen Esfandbod
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 982 181 631
Email address
sfandbod@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Pooyesh Darou Biopharmaceutical Company
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
2015-07-29, 1394/05/07
Actual recruitment end date
2016-02-09, 1394/11/20
Trial completion date
2017-07-11, 1396/04/20
Scientific title
The effectiveness of a single dose of peg-filgrastim (PD-Lasta) compared with Filgrastim (PD-grastim) to increase the absolute number of neutrophils (ANC) in patients with AML after chemotherapy
Public title
The effect of long-acting subcutaneous drug in increasing white blood cells in patients with leukemia after chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Denovo AML
Age 15-65
Achieved complete remission after induction chemotherapy
Received high dose of Cytarabine in consolidation chemotherapy
Exclusion criteria:
Secondary AML
ECOG performance status≥3
Have any effective disease (such as cardiovascular disease, renal disease, liver disease, pulmonary disease, diabetes, high blood pressure etc.) or receiving drugs and continuous treatment
Age
From 15 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
58
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
with 6 patients block randomized to two classes of the drugs
Blinding (investigator's opinion)
Single blinded
Blinding description
AML patients were blindly allocated to short acting and long acting group receiving short acting and long acting G-CSF respetively
Placebo
Not used
Assignment
Parallel
Other design features
Haphazard number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz Boulevard, Cornre of the Ghods Street
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2015-08-03, 1394/05/12
Ethics committee reference number
27325
Health conditions studied
1
Description of health condition studied
Acute Meyeloid Lukemia
ICD-10 code
C81-C96 -
ICD-10 code description
C81-C96 Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue - C92.0Acute myeloblastic leukaemia [AML]
Primary outcomes
1
Description
The time of reaching ANC above 1500/ul by using PD-lasta
Timepoint
Patient daily absolute neutrophil count (ANC) record until ANC reaches above 1500 per microlitre
Method of measurement
Colter
Secondary outcomes
1
Description
The effect of PD-Lasta in reducing the incidence of infection after chemotherapy
Timepoint
From day 14 after chemotherapy
Method of measurement
Clinical evaluation
Intervention groups
1
Description
Intervention group patients after receiving one or two courses of induction chemotherapy (cytarabine+daunorubicin) and after achieving complete remission, are treated with high dose ara-c (2 to 4 cycle). After 24 hour of chemotherapy, patients receive a single long-acting subcutaneous GCSF (PD-lasta).
Category
Treatment - Drugs
2
Description
Control group patients after receiving one or two courses of induction chemotherapy (cytarabine+daunorubicin) and after achieving complete remission, are treated with high dose ara-c (2 to 4 cycle). After 24 hour of chemotherapy patients receive daily short-acting GCSF (PD-filgrastim).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology Oncology ward of Valiasr Hospital, Imama Khomeini Hospital Complex
Full name of responsible person
Dr Mohsen Esfandbod
Street address
Valiasr Hospital of Imam Khomeini hospital complex, Gharib Street, End of the Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1593
Email
sfandbod@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pooyesh Darou Biopharmaceutical Company
Full name of responsible person
Shima Tanha
Street address
No.13, 5th Ave, Fatemi St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1415763863
Phone
+98 21 8897 0979
Email
info@pooyeshdarou.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pooyesh Darou Biopharmaceutical Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohsen Esfandbod
Position
Adult clinical Hematology Oncology/ Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
adult clinical hematologist oncologist
Street address
Keshavarz Boulevard, Cornre of the Ghods Street
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Fax
+98 21 8898 9664
Email
sfandbod@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Gholamreza Toogeh
Position
Adult clinical Hematology Oncology/ Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
adult clinical hematologist oncologist
Street address
Keshavarz Boulevard, Cornre of the Ghods Street
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Fax
+98 21 8898 9664
Email
gh_toogeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Zarrabi
Position
Research Administrate at Thrombosis Hemostasis Research Center/ MSc in Genetics
Latest degree
Master
Other areas of specialty/work
Medical Genetics
Street address
Keshavarz Boulevard, Cornre of the Ghods Street
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Fax
+98 21 8898 9664
Email
fariba_zarrabi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
comparison of long acting and short acting G-CSF in neutrophil recovery in AML patients after consolidation
When the data will become available and for how long
NON
To whom data/document is available
NON
Under which criteria data/document could be used
NON
From where data/document is obtainable
NON
What processes are involved for a request to access data/document
NON
Comments
No special comment
Trial results
Please tick if results have been published
Yes
Summary result posting date
2022-06-27, 1401/04/06
Table of baseline comparison
Characteristic
PD-Grastim(n=22)
PD-Lasta(n=29)
Age, years
Mean (SD)
46.5 (14.1)
42.3 (13.3)
Range
15-65
15-65
Sex, n (%)
Male
10 (41.4)
24 (82.8)
Female
12 (58.6)
5 (17.2)
*Cytogenetic, n
Intermediate
14
24
Favorable
3
4
Unfavorable
1
-
*Cytogenetic data were not available in five patients.
Participant flow diagram
Inclusion criteria
Exclusion criteria
Age 15-65
Secondary AML
Denovo AML
ECOG performance status≥3
Achieved complete remission after induction chemotherapy
Have any effective disease (such as cardiovascular disease, renal disease, liver disease, pulmonary disease, diabetes, high blood pressure etc.) or receiving drugs and continuous treatment
Received high dose of Cytarabine in consolidation chemotherapy
Table of variable outcomes' results
Table of adverse events
Complication
PD-Grastim(n=22)
PD-Lasta(n=29)
Fever, n (%)
3 (13.6%)
3 (10.3%)
Bone pain, n (%)
13 (59.1%)
12 (41.4%)
Fatigue, n (%)
1 ( 3.4% )
1 (3.4%)
Headache, n (%)
1 (3.4%)
1 (3.4%)
First publication date
2021-04-01, 1400/01/12
Abstract of published paper
The median time to recovery of neutrophils was 11.00 and 13.00 days for short-acting G-CSF (PD-Grastim) (n=22) and long-acting G-CSF (PD-Lasta) (n=29) groups, respectively (U=186.5, P>0.05 two-tailed). The incidence of adverse effects was similar in both short-acting G-CSF (PD-Grastim) and long-acting G-CSF (PD-Lasta) groups.