Condition 1: Acute Myeloblastic leukemia. Condition 2: Myelodysplastic Syndromes. Condition 3: Acute Lymphoblastic Leukemia. Acute myeloblastic leukemia Myelodysplastic syndromes Acute lymphoblastic leukemia [ALL]
Conditions
Interventions
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 ne
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
50 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival. Timepoint: Monthly for 18 months after transplantation. Method of measurement: Visiting the patient and performing monthly lab tests in outpatient clinique. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactLeyla Sharifi Aliabadi
Tehran University of Medical Sciences
Outcome results
None listed