Comparison of conditioning regimens before Hematopoietic Cell Transplantation in patients with Acute Leukemia.

Phase 3

Recruiting

• Conditions: Condition 1: Acute Myeloblastic leukemia. Condition 2: Myelodysplastic Syndromes. Condition 3: Acute Lymphoblastic Leukemia.; Acute myeloblastic leukemia; Myelodysplastic syndromes; Acute lymphoblastic leukemia [ALL]; C92.0; C91.0

• Registration Number: IRCT20140818018842N25
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 84

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified