At a glance
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Allogeneic Hematopoietic Stem Cell Transplantation as Initial Salvage Therapy for Patients With Primary Induction Failure Acute Myeloid Leukemia Refractory to High-Dose Cytarabine-Based Induction Chemotherapy
In Brief
A Phase 2 clinical trial evaluating Busulfan, Fludarabine, and 10 other interventions for Leukemia. Completed, enrolled 11 participants across 1 site.
Detailed Summary
Objectives: Primary Objectives: 1. To determine the safety and feasibility of allogeneic hematopoietic stem cell transplantation (AHSCT) as initial salvage treatment for patients with primary induction failure (PIF) acute myeloid leukemia (AML). 2. To determine efficacy of AHSCT following decitabine, clofarabine, idarubicin, and cytarabine (DCIA) salvage chemotherapy evaluated by overall response rate (RR), defined as complete response (CR) or CR without platelet recovery (CRp) or CR with insufficient hematological recovery (CRi). Secondary Objectives: 1. To determine the percentage of patients with PIF AML eligible for AHSCT after up to 2 courses of induction chemotherapy. 2. To determine the early treatment-related mortality (TRM) (within first 4 weeks of first salvage chemotherapy regimen with DCIA and day 100 TRM after AHSCT. 3. To determine the efficacy DCIA regimen as salvage chemotherapy for patients with PIF AML (% of patients who achieve \</=5% bone marrow blasts prior to AHSCT. 4. To determine the TRM at 1 year, relapse rate (RR), overall survival (OS) and event-free survival (EFS) for patients with PIF AML treated with DCIA followed by early AHSCT.
Study Details
Timeline
Interventions
Test dose Busulfan 32 mg/m2 given by vein on Day -8. Busulfan AUC 5,000 by vein on Days -6 to -3.
Fludarabine 10 mg/m2 by vein on Days -6 to -3.
Salvage Chemotherapy Before Transplant: Clofarabine 15 mg/m2 by vein on Days 6 - 9. Stem Cell Transplant: Clofarabine 40 mg/m2 by vein on Days -6 to -3.
Total body irradiation (TBI) delivered at 2Gy on Day -2.
Thymoglobulin 2.0 mg/Kg by vein on Days -3 and -2.
Fresh or cryopreserved bone marrow or peripheral blood (PB) progenitor cells infused on Day 0. Goal is to infuse 4 X 106 CD34+ cells/kg if PB or \>3.0 X 108 marrow mononuclear cells/kg if bone marrow.
Cyclophosphamide 50 mg/kg by vein on Days +3 and +4.
Tacrolimus 0.015 mg/kg/day by vein or mouth on Day +5.
Mycophenolate mofetil 15 mg/kg/dose by vein or by mouth three times a day from Day +5 to Day+100.
20 mg/m2 by vein on Days 1 - 5.
1 g/m2 by vein on Days 6 - 10.
10 mg/m2 by vein on Days 6 - 8.