Phase I/II Study of SY-1425 (Tamibarotene) in Combination With Azacitidine and Venetoclax for Patients With Chronic Myelomonocytic Leukemia

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06085638
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Chronic Myelomonocytic Leukemia

Eligibility Criteria

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

Interventions

  • Azacitidine — DRUG
    Given by SC (under the skin) or IV (vein)
  • Tamibarotene — DRUG
    Given by PO
  • Venetoclax — DRUG
    Given by PO TAMIBAROTENE Azacitidine Azacitidine, 5-azacytidine, 5-aza, Vidaza™, 5-AZC, AZA-CR, Ladakamycin, NSC-102816, Azacytidine Venetoclax ABT-199, GDC-0199, Venetoclax

Study Details

To learn if adding venetoclax to the chemotherapy combination of tamibarotene and azacitidine is more effective than tamibarotene and azacitidine alone in treating higher-risk CMM

Key Dates

Start date
Sep 14, 2023
Status verified
Mar 2024
Primary completion
Oct 20, 2023
Completion
Oct 20, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm1: Cohort 1: Azacitidine + Tamibarotene
    Participants will receive azacitidine on Days 1-7 of each cycle and tamibarotene 2 times a day every day. Up to 20 participants will be enrolled in Cohort 1.
  • Experimental: Arm2: Cohort 2,3: Azacitidine + Tamibarotene + Venetoclax
    Participants will receive azacitidine on Days 1-7 of each cycle, tamibarotene 2 times a day every day, and venetoclax on either Days 1-7 or Days 1-14 of each cycle, depending on the dose level you are assigned at enrollment. Up to 12 participants will be enrolled in Cohort 2. Once Cohort 2 is complete, Cohort 3 will begin. Participants in Cohort 3 will receive the recommended dosing schedule found in Cohort 2 (azacitidine on Days 1-7, tamibarotene 2 times a day every day, and venetoclax on either Days 1-7 or Days 1-14

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average of 1 year ]

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