Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Acute Myeloid LeukemiaMyelodysplastic SyndromeChronic Myeloid Leukemia
Interventions
DRUG

Clofarabine

Day -6 to Day -3 for Arm 1 = 10 mg/m\^2 intravenous (IV) Daily; Arm 2 = 20 mg/m\^2 IV Daily; Arm 3 = 30 mg/m\^2 IV Daily; Arm 4 = 40 mg/m\^2 IV Daily

DRUG

Busulfan

"Day -6 to Day -3 for Arm 1: 30 mg/m\^2 IV Daily; Arm 2: 20 mg/m\^2 IV Daily; Arm 3: 10 mg/m\^2 IV Daily; Arm 4: 40 mg/m\^2 IV Daily.~Test dose Day -8 32 mg/ m\^2 IV over 45 min, rest on Day -7."

DRUG

Fludarabine

Day -6 to Day -3 for Arm 1: 30 mg/m\^2 IV Daily; Arm 2: 20 mg/m\^2 IV Daily; Arm 3: 10 mg/m\^2 IV Daily

OTHER

Stem Cell Infusion

Day 0 stem cell infusion (Bone marrow or peripheral blood progenitor cells (PBPC))

DRUG

Thymoglobulin (ATG)

Day -3 to Day -1 at 0.5 mg/kg IV on Day -3; 1.5 mg/kg on Day -2 and 2.0 mg/kg on Day -1.

DRUG

Filgrastim

Subcutaneous injection daily, starting 1 week after Stem Cell Transplant.

Trial Locations (1)

77030

UT MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

Genzyme, a Sanofi Company

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT00469014 - Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter