GVHD Prophylaxis With Post-transplantation Bendamustine in Refractory Leukemia
Leukemia, Acute Lymphoblastic, Acute Myeloid Leukemia, Mixed-Lineage Acute Leukemias
About this trial
This is an interventional treatment trial for Leukemia, Acute Lymphoblastic focused on measuring Allogeneic Transplantation, Hematopoietic Stem Cell Transplantation, Leukemia, Acute Lymphoblastic, Acute Myeloid Leukemia, Mixed-Lineage Acute Leukemias, Immune System Diseases, Immunosuppressive Agents, Myeloablative Agonists, Busulfan, Fludarabine, Antineoplastic Agents, Alkylating, Bendamustine Hydrochloride
Eligibility Criteria
Inclusion Criteria:
- Diagnosis: Acute Myeloblastic Leukemia Acute Lymphoblastic Leukemia Mixed-Lineage Acute Leukemias
- Disease, refractory to at list one course of induction chemotherapy or immunotherapy
- More than 5% clonal blasts in the bone marrow or peripheral blood at the time of inclusion
- Signed informed consent
- Matched related, 8-10/10 HLA-matched unrelated or haploidentical donor available. The HLA typing is performed by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.
- No second tumors
- No severe concurrent illness
- No previous autologous or allogeneic stem cell transplantations
Exclusion Criteria:
- Karnofsky index <70%
- Moderate or severe cardiac dysfunction, left ventricular ejection fraction <50%
- Moderate or severe decrease in pulmonary function, FEV1 <70% or DLCO<70% of predicted
- Respiratory distress >grade I
- Severe organ dysfunction: AST or ALT >5 upper normal limits, bilirubin >1.5 upper normal limits, creatinine >1.5 upper normal limits
- Creatinine clearance < 60 mL/min
- Uncontrolled bacterial or fungal infection at the time of enrollment, defined by CRP level >70 mg/L or positive procalcitonin in patient with adequate empirical antibacterial and antifungal therapy.
- Requirement for vasopressor support at the time of enrollment
- Pregnancy
- Somatic or psychiatric disorder making the patient unable to sign informed consent
Sites / Locations
- First Pavlov State Medical University of St. Petersburg
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
280 mg/m2 bendamustine
200 mg/m2 bendamustine
140 mg/m2 bendamustine
10 patients Days -7 through -2: Fludarabine 30 mg/m2/day iv x 6 days Days -6 through -3: Busulfan 1 mg/kg po qid №14 Day 0: Infusion of unmanipulated graft Day +3 and +4: Bendamustine 140 mg/m2/day iv.
10 patients Days -7 through -2: Fludarabine 30 mg/m2/day iv x 6 days Days -6 through -3: Busulfan 1 mg/kg po qid №14 Day 0: Infusion of unmanipulated graft Day +3 and +4: Bendamustine 100 mg/m2/day iv
10 patients Days -7 through -2: Fludarabine 30 mg/m2/day iv x 6 days Days -6 through -3: Busulfan 1 mg/kg po qid №14 Day 0: Infusion of unmanipulated graft Day +3, +4: Bendamustine 70 mg/m2/day iv.