A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05365035
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myelodysplastic Syndromes
  • Myeloproliferative Chronic Myelomonocytic Leukemia

Eligibility Criteria

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

Interventions

  • Cladribine — DRUG
    Given by Vein (IV)
  • Cytarabine — DRUG
    Given under the skin; subcutaneous injection (SQ)
  • Venetoclax — DRUG
    Given by PO
  • Azacitidine — DRUG
    Given by IV or subcutaneous injection (SQ)

Study Details

To learn if the combination of cladribine, cytarabine, venetoclax, and azacitidine can help to control higher-risk myelodysplastic syndrome (MDS) with excess blasts and/or higher-risk chronic myelomonocytic leukemia (CMML).

Key Dates

Start date
Sep 23, 2022
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: cladribine, cytarabine, venetoclax, and azacitidine
    Participants will receive cladribine, cytarabine, and venetoclax for 2 cycles and then azacitidine and venetoclax for 2 cycles. Participants will repeat this pattern of 2 cycles each for up to a total of 18

Primary Outcome Measure

To establish the overall survival (OS). [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Guillermo Bravo, MD
[email protected]
713-794-3604
Guillermo Bravo, MD (PRINCIPAL_INVESTIGATOR)

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

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