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IRCT20151020024625N8 IRCT 2018-06-30 Semnan University of Medical Sciences Pegfilgrastim compared with filgrastim in patients with acute myeloid leukemia after chemotherapy A single dose of pegfilgrastim compared with daily filgrastim for supporting neutrophil recovery in patients with acute myeloid leukemia after chemotherapy 2017-01-20 anticipated 58 Complete https://irct.ir/trial/31942 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization by six block randomization, Blinding description: The person who evaluate outcome is unaware from type of intervention. 2-3 Neutropenia. Intervention 1: Intervention group: Patients received one or two course induction chemotherapy (idarubicin 12 mg/m2 days 1–3, cytarabine 100 mg/m2 twice daily days 1–7). If complete remission was achieved, patients received one course of high-dose cytarabine consolidation therapy (3 g/m2 if aged <55 years, 2 g/m2 if aged ≥ 55 years). Then, Filgrastim 5 μg/kg SC was administered daily beginning 24 hours after chemotherapy. Then complete blood cell count and differential and peripheral blood smear were performed for all patients and patients evaluated for outcomes and complications for up to 21 days. Intervention 2: Intervention group: Patients received a course induction chemotherapy (idarubicin 12 mg/m2 days 1–3, cytarabine 100 mg/m2 twice daily days 1–7). If complete remission was achieved, patients received one course of high-dose cytarabine consolidation therapy (3 g/m2 if aged <55 years, 2 g/m2 if aged ≥ 55 years). Then, Pegfilgrastim was administered as a single SC 6-mg dose approximately 24 hours after completing chemotherapy. Then complete blood cell count and differential and peripheral blood smear were performed for all patients and patients evaluated for outcomes and complications for up to 21 days. Yes - There is a plan to make this available What will be shared: Data will publish as final report. When: َAfter completing To whom: Researchers and Physicians Conditions: For similar studies and clinical use Where to obtain: Scientific responsible, Farahnaz Ghahremanfard MD How to obtain: Call contact or e.mail Comments:
public Farahnaz Ghahremanfard MD
Basidj Boulevard
Semnan Iran (Islamic Republic of) 3519899951 +98 23 3142 2120 f_ghahremanfard@yahoo.com Semnan University of Medical Sciences scientific Farahnaz Ghahremanfard MD
Basidj Boulevard
Semnan Iran (Islamic Republic of) 3519899951 +98 23 3142 2120 f_ghahremanfard@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Patients who went to remission after induction chemotherapy. 15 years 65 years Both Non remission Sepsis during or after chemotherapy History of hypersensitivity reactions to E. coli-derived proteins and other drugs D72 Other disorders of white blood cells Treatment - Other Treatment - Other Intervention group: Patients received one or two course induction chemotherapy (idarubicin 12 mg/m2 days 1–3, cytarabine 100 mg/m2 twice daily days 1–7). If complete remission was achieved, patients received one course of high-dose cytarabine consolidation therapy (3 g/m2 if aged <55 years, 2 g/m2 if aged ≥ 55 years). Then, Filgrastim 5 μg/kg SC was administered daily beginning 24 hours after chemotherapy. Then complete blood cell count and differential and peripheral blood smear were performed for all patients and patients evaluated for outcomes and complications for up to 21 days. Intervention group: Patients received a course induction chemotherapy (idarubicin 12 mg/m2 days 1–3, cytarabine 100 mg/m2 twice daily days 1–7). If complete remission was achieved, patients received one course of high-dose cytarabine consolidation therapy (3 g/m2 if aged <55 years, 2 g/m2 if aged ≥ 55 years). Then, Pegfilgrastim was administered as a single SC 6-mg dose approximately 24 hours after completing chemotherapy. Then complete blood cell count and differential and peripheral blood smear were performed for all patients and patients evaluated for outcomes and complications for up to 21 days. Neutrophil count. Timepoint: Daily< up to 21 days after intervention. Method of measurement: Complete blood cell count and peripheral blood smear. Semnan University of Medical Sciences Approved 2015-10-06 Ethics Committee of Semnan University of Medical Sciences Basidj Boulevard Semnan Semnan Iran (Islamic Republic of)