NCT00801489View on ClinicalTrials.gov

Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

PHASE2RecruitingINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

April 4, 2007

Primary Completion Date

October 11, 2028

Study Completion Date

October 11, 2028

Conditions
Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1de Novo Myelodysplastic SyndromeHigh Risk Myelodysplastic SyndromeInv(16)Myelodysplastic Syndrome With Excess Blastst(16;16)t(8;21)Untreated Adult Acute Myeloid Leukemia
Interventions
DRUG

Cytarabine

Given IV

DRUG

Decitabine

Given IV

BIOLOGICAL

Filgrastim-sndz

Given SC

DRUG

Fludarabine Phosphate

Given IV

DRUG

Gemtuzumab Ozogamicin

Given IV

DRUG

Idarubicin

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

Trial Locations (1)

77030

RECRUITING

M D Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

M.D. Anderson Cancer Center

OTHER