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

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.

Conditions

• Leukemia

Interventions

DRUG

Busulfan

Test dose Busulfan 32 mg/m2 given by vein on Day -8. Busulfan AUC 5,000 by vein on Days -6 to -3.

DRUG

Fludarabine

Fludarabine 10 mg/m2 by vein on Days -6 to -3.

DRUG

Clofarabine

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.

RADIATION

Total Body Irradiation (TBI)

Total body irradiation (TBI) delivered at 2Gy on Day -2.

DRUG

Thymoglobulin

Thymoglobulin 2.0 mg/Kg by vein on Days -3 and -2.

BIOLOGICAL

Stem Cell Infusion

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.

DRUG

Cyclophosphamide

Cyclophosphamide 50 mg/kg by vein on Days +3 and +4.

DRUG

Tacrolimus

Tacrolimus 0.015 mg/kg/day by vein or mouth on Day +5.

DRUG

Mycophenolate mofetil

Mycophenolate mofetil 15 mg/kg/dose by vein or by mouth three times a day from Day +5 to Day+100.

DRUG

Decitabine

20 mg/m2 by vein on Days 1 - 5.

DRUG

Cytarabine

1 g/m2 by vein on Days 6 - 10.

DRUG

Idarubicin

10 mg/m2 by vein on Days 6 - 8.

Sponsors & Collaborators

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Stefan Ciurea, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-14

Primary Completion

2020-09-22

Completion

2021-09-22

FDA Drug

Yes

Countries

• United States

Study Locations