Condition 1: Acute lymphoblastic leukemia (ALL). Condition 2: Acute myeloblastic leukemia (AML). Acute lymphoblastic leukemia [ALL] Acute myeloblastic leukemia
Conditions
Interventions
Intervention group: Cyclophosphamide at a dose of 50 mg per kg of body weight on day three post-transplant, followed by bendamustine at a dose of 90 mg per kg of body weight on day four post-transpl
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Years to 60 Years
Inclusion criteria
Inclusion criteria: Diagnosis of acute leukemia based on histologic and cytogenetic criteria. Age between 1 and 60 years. Absence of a fully Human leukocyte antigen(HLA)-matched donor (matched sibling or fully matched unrelated donor) or a donor mismatched in a single allele (9/10 mismatched unrelated donor). 4. Karnofsky Performance Status (KPS) or Lansky Performance Score greater equal than 70. Adequate organ function (renal, hepatic, cardiac, and pulmonary).
Exclusion criteria
Exclusion criteria: Uncontrolled and active infections at the time of enrollment. Prior history of receiving an allogeneic transplantation. Active secondary malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutrophil engraftment(when the absolute neutrophil count consistently exceeds 0.5 × (10)9/L for 3 days in a row (without growth factor support). Timepoint: Daily measurements. Method of measurement: According to total blood count lab test.;Platelet engraftment (when the patient is independent of platelet transfusion for at least 7 days with a platelet count >20 × 10?/L). Timepoint: Daily measurments. Method of measurement: According to total blood count lab test.;The occurrence of Graft versus Host disease according to the MAGIC criteria. Timepoint: Daily assesments. Method of measurement: In accordance with the MAGIC criteria.;Overall survival. Timepoint: Patients will be followed daily during hospitalization and then monthly after discharge by trained study personnel. Method of measurement: Patients will be followed daily during hospitalization and then monthly after discharge by trained study personnel, through interviews with the patient and their family.;Relapse. Timepoint: Patients will be followed daily during hospitalization and then monthly after discharge. Method of measurement: Patients will be followed daily during hospitalization and then monthly after discharge by a trained interviewer and according to the physician's findings and in accordance to laboratory and clinical criteria.;Progression Free survival. Timepoint: Patients will be followed daily during hospitalization and then monthly after discharge. Method of measurement: Patients will be followed daily during hospitalization and then monthly after discharge by a trained interviewer and according to the physician's findings and in accordance to laboratory and clinical criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cytomegalovirus(CMV) reactivation. Timepoint: Weekly. Method of measurement: Polymerase chain reaction(PCR) lab test.;Hemorrhagic cystitis occurrance. Timepoint: Patients will be followed daily during hospitalization and then monthly after discharge. Method of measurement: Patients will be followed daily during hospitalization and then monthly after discharge by trained study personnel, through interviews with the patient and their family. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactTahereh Rostami
Tehran University of Medical Sciences
Outcome results
None listed