NCT02115295View on ClinicalTrials.gov

Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia

PHASE2RecruitingINTERVENTIONAL
Enrollment

508

Participants

Timeline

Start Date

May 19, 2014

Primary Completion Date

May 31, 2030

Study Completion Date

May 31, 2030

Conditions
Acute Biphenotypic LeukemiaAcute Myeloid LeukemiaBlast Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveBlasts 10 Percent or More of Bone Marrow Nucleated CellsBlasts 10 Percent or More of Peripheral Blood White Cellsde Novo Myelodysplastic SyndromeMyelodysplastic SyndromePreviously Treated Myelodysplastic SyndromeRecurrent Acute Myeloid LeukemiaRecurrent Chronic Myelogenous Leukemia, BCR-ABL1 PositiveRefractory Acute Myeloid LeukemiaRefractory Chronic Myelogenous Leukemia, BCR-ABL1 PositiveSecondary Acute Myeloid LeukemiaUntreated Adult Acute Myeloid Leukemia
Interventions
DRUG

Cladribine

Given IV

DRUG

Cytarabine

Given IV

DRUG

Gilteritinib

Given PO

DRUG

Idarubicin

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Midostaurin

Given PO

DRUG

Venetoclax

Given PO

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