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IRCT20140818018842N25 IRCT 2022-09-01 Tehran University of Medical Sciences Comparison of conditioning regimens before Hematopoietic Cell Transplantation in patients with Acute Leukemia. - Comparison of Myeloablative versus Reduced-Intensity conditioning regimen before Hematopoietic Cell Transplantation in Measurable Residual Disease negative, 50 years or older patients with Acute Myeloid Leukemia, Myelodysplastic Syndromes and Acute Lymphoblastic Leukemia: A phase III Randomized Controlled Trial. 2022-04-04 anticipated 84 Complete https://irct.ir/trial/62418 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assigning to the study groups is parallel; group 1 is considered the intervention group which will receive the reduced intensity conditioning regimen, and group 2 is the control group which will receive the myeloablative regimen. The balanced block randomization list will be generated through the research institute's web-based software; after entering the sample size 84 and considering the block size of 4, according to this balanced block randomization list, a sequence of numbers is created, and this sequence of numbers is defined in the system. If the patients meet the criteria of the study after obtaining informed consent, their national code will be entered into the system, and the software will announce the code of each patient. 3 Condition 1: Acute Myeloblastic leukemia. Condition 2: Myelodysplastic Syndromes. Condition 3: Acute Lymphoblastic Leukemia. Intervention 1: Intervention group: patients with acute leukemia who are candidates for allogeneic Hematopoietic Cell Transplantation and are between 50-65 years old and Measurable Residual Disease negative will be included in the trial. After randomization, they will be transplanted according to the reduced-intensity conditioning regimen. Reduced-intensity conditioning regimen consists of: Fludarabine (ACTOVERCO): 30 mg/m2/day day -6 to -2 before transplantation and Busulfan (Nanoalvand): 3.2 mg/kg/day, from day -5 to -4 before transplantation. Intervention 2: Control group: patients with acute leukemia who are candidates for allogeneic Hematopoietic Cell Transplantation and are between 50-65 years and Measurable Residual Disease negative will be included in the trial. After randomization, they will be transplanted according to the myeloablative conditioning regimen. Myeloablative conditioning regimen consists of: Busulfan (Nanoalvand): 3.2 mg/kg/day, from day -6 to -3 and Cyclophosphamide (Baxter): 60 mg/kg/day, from day -2 to -1 before transplantation. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Leyla Sharifi Aliabadi
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
Tehran Iran (Islamic Republic of) 1417713135 00982288004140 ctu@sina.tums.ac.ir Tehran University of Medical Sciences scientific Tanaz Sayar Bahri
Shariati Hospital, North Kargar Ave.
Tehran Iran (Islamic Republic of) 1411713135 - tanaz.bahri@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients from 50 to 65 years old Patients with diagnosis of Myelodysplastic Syndromes , Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia who are Measurable Residual Disease negative pre-transplant within 30 days of enrollment. Patient and donor are allowed to be a full match (8/8), or at least Human Leukocyte Antigens (HLA)-A, -B, -C and DRB1 matched. Cardiac function: Ejection Fraction ≥ 40% Hepatic function: total bilirubin and Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2,5 x the upper limit of normal Pulmonary function: Forced expiratory volume (FEV1) ≥ 50% Renal function: creatinine clearance > 40 mL/min based on the Cockroft-Gault formula Hematopoietic Cell Transplantation-specific Comorbidity Index (HCT-CI) score <4 Signed informed consent. 50 years 65 years Both Prior allogeneic stem cell transplantation Symptomatic coronary artery disease Karnofsky Performance Score < 70 Central nervous system involvement Patients with uncontrolled bacterial, viral or fungal infection Females who are pregnant or breastfeeding. Patients seropositive for human immunodeficiency virus. C92.0 D46 C91.0 Acute myeloblastic leukemia Myelodysplastic syndromes Acute lymphoblastic leukemia [ALL] Treatment - Other Treatment - Other Intervention group: patients with acute leukemia who are candidates for allogeneic Hematopoietic Cell Transplantation and are between 50-65 years old and Measurable Residual Disease negative will be included in the trial. After randomization, they will be transplanted according to the reduced-intensity conditioning regimen. Reduced-intensity conditioning regimen consists of: Fludarabine (ACTOVERCO): 30 mg/m2/day day -6 to -2 before transplantation and Busulfan (Nanoalvand): 3.2 mg/kg/day, from day -5 to -4 before transplantation. Control group: patients with acute leukemia who are candidates for allogeneic Hematopoietic Cell Transplantation and are between 50-65 years and Measurable Residual Disease negative will be included in the trial. After randomization, they will be transplanted according to the myeloablative conditioning regimen. Myeloablative conditioning regimen consists of: Busulfan (Nanoalvand): 3.2 mg/kg/day, from day -6 to -3 and Cyclophosphamide (Baxter): 60 mg/kg/day, from day -2 to -1 before transplantation. Overall survival. Timepoint: Monthly for 18 months after transplantation. Method of measurement: Visiting the patient and performing monthly lab tests in outpatient clinique. Disease Free survival after transplantation. Timepoint: 1, 3, 6, 9, 12 and 18 months post transplant. Method of measurement: Bone marrow biopsy and aspiration and flowcytometry and chimerism. Transplant Related Mortality. Timepoint: Monthly for 18 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique. Incidence of acute graft versus host disease. Timepoint: Monthly for 4 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique. Incidence of chronic graft versus host disease. Timepoint: Monthly for 18 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique. Relapse Incidence. Timepoint: 1, 3, 6, 9, 12 and 18 months post transplant. Method of measurement: Bone marrow biopsy and aspiration and flowcytometry and chimerism. Incidence of infectious complications post-transplant. Timepoint: Monthly for 18 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique. Tehran University of Medical Sciences Approved 2022-03-15 Ethic committee of Hematology- Oncology and cell therapy Research Institute, Tehran University of Me Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy Tehran Tehran Iran (Islamic Republic of)