DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04752163
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Recurrent Acute Lymphoblastic Leukemia
  • Recurrent Acute Myeloid Leukemia
  • Recurrent Chronic Myelomonocytic Leukemia
  • Recurrent Myelodysplastic Syndrome
  • Refractory Acute Lymphoblastic Leukemia
  • Refractory Acute Myeloid Leukemia
  • Refractory Chronic Myelomonocytic Leukemia
  • Refractory Myelodysplastic Syndrome

Eligibility Criteria

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

Interventions

  • DS-1594b — DRUG
    Given DS-1594b PO
  • Azacitidine — DRUG
    Given IV or SC
  • Cyclophosphamide — DRUG
    Given IV
  • Cytarabine — DRUG
    Given IT
  • Dexamethasone — DRUG
    Given PO or IV
  • Filgrastim — BIOLOGICAL
    Given SC
  • Leucovorin — DRUG
    Given IV or PO
  • Mesna — DRUG
    Given IV
  • Methotrexate — DRUG
    Given IT
  • Prednisone — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV
  • Venetoclax — DRUG
    Given PO
  • Vincristine — DRUG
    Given IV

Study Details

This phase I/II trial studies the effect of DS-1594b with or without azacitidine, venetoclax, or mini-HCVD in treating patients with acute myeloid leukemia or acute lymphoblastic leukemia that has come back (recurrent) or not responded to treatment (refractory). Chemotherapy drugs, such as azacitidine, venetoclax, and mini-HCVD, 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. DS-1594b may inhibit specific protein bindings that cause blood cancer. Giving DS-1594b, azacitidine, and venetoclax, or mini-HCVD may work better in treating patients with acute myeloid leukemia or acute lymphoblastic leukemia.

Key Dates

Start date
Mar 25, 2021
Status verified
May 2025
Primary completion
Nov 8, 2023
Completion
Nov 8, 2023

Study Design

Enrollment
17 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A and B (DS-1594b)
    Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
  • Experimental: Cohort C (DS-1594b, venetoclax, azacitidine)
    Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
  • Experimental: Cohort D (DS-1594b, mini-HCVD)
    Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description.
  • Experimental: Phase I (DS-1594b) Cohort 1
    Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily.
  • Experimental: Phase I (DS-1594b) Cohort 2
    Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily.
  • Experimental: Phase I (DS-1594b) Cohort 3
    Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily.
  • Experimental: Phase I (DS-1594b) Cohort 4
    Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily.
  • Experimental: Phase I (DS-1594b) Cohort 5
    Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) (Phase I) [ Time Frame: Day 28 ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
M D Anderson Cancer Center· Houston, TX

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