Fludarabine-IV Busulfan ± Clofarabine and Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Phase 3 Completed 256 enrolled M.D. Anderson Cancer Center Sanofi · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn if combining busulfan with clofarabine and fludarabine can help control the disease better than the previous standard method (using busulfan and fludarabine alone) in patients with AML or MDS. The safety of this combination therapy will also be studied.

Timeline

Start: 2011-11-02
Primary completion: 2020-12-14
Completion: 2020-12-14

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Busulfan	Small molecule	130 mg/m2	Intravenous
Subject	Busulfan	Small molecule	6000 unknown	Intravenous
Subject	Clofarabine	Other / unclassified	30 mg/m2	Intravenous
Subject	Fludarabine	Small molecule	10 mg/m2	Intravenous
Subject	Fludarabine	Small molecule	40 mg/m2	Intravenous
Background	Methotrexate	Small molecule	5 mg/m2	Intravenous
Background	Tacrolimus	Small molecule	0.015 mg/kg	Oral
Background	Thymoglobulin	Protein / enzyme biologic	2 mg/kg	Intravenous

Fludarabine-IV Busulfan ± Clofarabine and Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Summary

Timeline

Drugs

Indications