NCT00569010 - Phase I/II Study of 5-Azacytidine With Ara-C in Patients With Relapsed/Refractory Acute Myelogenous Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

October 31, 2009

Study Completion Date

October 31, 2009

Conditions

Acute Myelogenous LeukemiaMyelodysplastic SyndromeLeukemia

Interventions

DRUG

Azacitidine

Group 1 and 3 at Level 0 = 37.5 mg/m\^2 IV Over 20-30 minutes Daily for 7 Days Group 2 and 4 at Level 1 = 75.0 mg/m\^2 IV Over 20-30 minutes Daily for 7 days

DRUG

Ara-C

"Group 1 and 2 at Low-Dose = 100 mg/m\^2 Daily continuous intravenous infusion (CIV) for 7 days~Arms 3 and 4 at High-dose = 1 g/m\^2 Daily CIV for 4 days (age\<65 years) or 3 days (age\>=65 years)"

Trial Locations (1)

77030

U.T.M.D. Anderson Cancer Center, Houston