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IRCT2015072623349N1 IRCT 2016-01-19 Pooyesh Darou Biopharmaceutical Company The effect of long-acting subcutaneous drug in increasing white blood cells in patients with leukemia after chemotherapy none 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 2015-07-23 anticipated 58 Complete https://irct.ir/trial/19931 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Haphazard number table, Randomization description: with 6 patients block randomized to two classes of the drugs, Blinding description: AML patients were blindly allocated to short acting and long acting group receiving short acting and long acting G-CSF respetively. 3 Acute Meyeloid Lukemia. Intervention 1: 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). Intervention 2: 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). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8381103/ 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. Yes - There is a plan to make this available What will be shared: comparison of long acting and short acting G-CSF in neutrophil recovery in AML patients after consolidation When: NON To whom: NON Conditions: NON Where to obtain: NON How to obtain: NON Comments: No special comment
public Dr Mohsen Esfandbod
Keshavarz Boulevard, Cornre of the Ghods Street
Tehran Iran (Islamic Republic of) 1417653761 +98 21 81631 sfandbod@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr Gholamreza Toogeh
Keshavarz Boulevard, Cornre of the Ghods Street
Tehran Iran (Islamic Republic of) 1417653761 +98 21 81631 gh_toogeh@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Denovo AML Age 15-65 Achieved complete remission after induction chemotherapy Received high dose of Cytarabine in consolidation chemotherapy 15 years 65 years Both Secondary AML ECOG performance statusā‰„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 C81-C96 - C81-C96 Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue - C92.0Acute myeloblastic leukaemia [AML] Treatment - Drugs Treatment - Drugs 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). 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). 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. The effect of PD-Lasta in reducing the incidence of infection after chemotherapy. Timepoint: From day 14 after chemotherapy. Method of measurement: Clinical evaluation. Pooyesh Darou Biopharmaceutical Company Approved 2015-08-03 Ethics committee of Tehran University of Medical Sciences Keshavarz Boulevard, Cornre of the Ghods Street Tehran Tehran Iran (Islamic Republic of)