Overview

Allogeneic Hematopoietic Stem Cell Transplantation (AlloSCT) Initial Salvage Therapy for Induction Failure Acute Myeloid Leukemia (AML)

Status:
Active, not recruiting

Trial end date:
2023-09-01

Target enrollment:

Participant gender:

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 Phase: Phase 2

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Treatments:

Antilymphocyte Serum
Azacitidine
Busulfan
Clofarabine
Cyclophosphamide
Cytarabine
Decitabine
Fludarabine
Fludarabine phosphate
Idarubicin
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus
Thymoglobulin
Vidarabine