Clofarabine Combinations in Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS) and Myeloid Blast Phase Chronic Myeloid Leukemia (CML)

PHASE2CompletedINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

December 31, 2003

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Acute Myeloid LeukemiaMyelodysplastic SyndromeChronic Myeloid Leukemia
Interventions
DRUG

Clofarabine 40mg/m^2

40 mg/m\^2 by vein over 1 hour daily for 5 days.

DRUG

Idarubicin 10mg/m^2

"10 mg/m\^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle.~Clofarabine + Idarubicin plus Ara-C:~6 mg/m\^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle."

DRUG

Ara-C 0.75 g/m^2

0.75 g/m\^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle.

DRUG

Clofarabine 22.5mg/m^2

22.5 mg/m\^2 by vein over 1 hour daily for 5 days.

DRUG

Ara-C 1 g/m^2

1 g/m\^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle.

DRUG

Idarubicin 6 mg/m^2

6 mg/m\^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle.

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

NCT00067028 - Clofarabine Combinations in Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS) and Myeloid Blast Phase Chronic Myeloid Leukemia (CML) | Biotech Hunter | Biotech Hunter