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

PHASE2CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

September 14, 2015

Primary Completion Date

September 22, 2020

Study Completion Date

September 22, 2021

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.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
lead

M.D. Anderson Cancer Center

OTHER

NCT02441803 - Allogeneic Hematopoietic Stem Cell Transplantation (AlloSCT) Initial Salvage Therapy for Induction Failure Acute Myeloid Leukemia (AML) | Biotech Hunter | Biotech Hunter