Venetoclax and Decitabine in Treating Participants With Relapsed/Refractory Acute Myeloid Leukemia or Relapsed High-Risk Myelodysplastic Syndrome

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03404193
Phase
PHASE2
Status
Terminated

Conditions

  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
  • Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Chronic Myelomonocytic Leukemia
  • Mixed Phenotype Acute Leukemia
  • Myelodysplastic Syndrome
  • Recurrent Acute Biphenotypic Leukemia
  • Recurrent Acute Myeloid Leukemia
  • Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Recurrent Chronic Myelomonocytic Leukemia
  • Recurrent Mixed Phenotype Acute Leukemia
  • Refractory Acute Myeloid Leukemia
  • Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Refractory Chronic Myelomonocytic Leukemia
  • Refractory Mixed Phenotype Acute Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Decitabine — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Venetoclax — DRUG
    Given PO

Study Details

This phase II trial studies how well venetoclax and decitabine work in treating participants with acute myeloid leukemia that has come back or does not respond to treatment, or with high-risk myelodysplastic syndrome that has come back. Drugs used in chemotherapy, such as venetoclax and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Key Dates

Start date
Jan 18, 2018
Status verified
Mar 2026
Primary completion
Mar 5, 2026
Completion
Mar 5, 2026

Study Design

Enrollment
235 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (decitabine, venetoclax)
    Participants receive decitabine IV over 1 hour on days 1-10 and may also receive decitabine on days 1-5 after achieving complete remission/complete remission with incomplete count recovery during consolidation/maintenance. Participants also receive venetoclax PO daily on days 1-28 of cycle 1 and on days 1-21 of subsequent cycles. Treatment repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Up to 4 cycles (112 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
M D Anderson Cancer Center· Houston, TX

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