Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)

PHASE2RecruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

February 7, 2012

Primary Completion Date

February 1, 2026

Study Completion Date

February 1, 2026

Conditions
Leukemia
Interventions
DRUG

Cladribine

"Induction cycle: 5 mg/m2 by vein on days 1 - 5 for up to 2, 28 day cycles.~Consolidation cycle: 5 mg/m2 by vein on days 1 - 3 of cycles 2, 5, 6, 9, 10, 13, 14, 17, and 18."

DRUG

Cytarabine

"Induction cycle: 20 mg subcutaneously twice daily on days 1-10 for up to 2, 28 day cycles.~Consolidation cycle: 20 mg subcutaneously twice daily on days 1 - 10 of cycles 2, 5, 6, 9, 10, 13, 14, 17, and 18."

DRUG

Decitabine

Consolidation cycle: 20 mg/m2 by vein over 1 to 2 hours on days 1-5 of cycles 3, 4, 7, 8, 11, 12, 15, and 16.

Trial Locations (1)

77030

RECRUITING

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
lead

M.D. Anderson Cancer Center

OTHER