Cladribine Venetoclax in Monocytic AML

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06232655
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Cladribine — DRUG
    A medication used to treat hairy cell leukemia (leukemic reticuloendotheliosis) and B-cell chronic lymphocytic leukemia. Cladribine, sold under the brand name Mavenclad, is used for the treatment of adults with highly active forms of relapsing-remitting multiple sclerosis.
  • Venetoclax — DRUG
    A medication used to treat adults with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or acute myeloid leukemia (AML).
  • Azacitidine — DRUG
    Medication used for the treatment of myelodysplastic syndrome, myeloid leukemia, and juvenile myelomonocytic leukemia. It is a chemical analog of cytidine, a nucleoside in DNA and RNA.. Azacitidine and its deoxy derivative, decitabine were first synthesized in Czechoslovakia as potential chemotherapeutic agents for cancer.

Study Details

Investigation of Relapsed or refractory AML with a monocytic phenotype after failure of hypomethylating agent+venetoclax

Key Dates

Start date
Feb 8, 2024
Status verified
Dec 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cladribine plus Venetoclax
    Subjects will receive cladribine at a dose of 5mg/m2 daily via intravenous infusion on days 1 through 5 of a 28 day cycle. Concomitantly, venetoclax will be administered orally at a dose of 100mg on day 1, 200mg on day 2, and 400mg daily on days 3 through 28.
  • Experimental: Alternating Aza/Ven and Clad/Ven
    Alternating 28-day consolidation cycles of Aza/Ven (even cycles) and Clad/Ven (odd cycles), while those who do not respond will come off the study.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: End of Treatment, an average of 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Universtiy of Colorado HospitalAuroraColorado80045
Derek Schatz
[email protected]
720-848-0628
Christine McMahon, MD (PRINCIPAL_INVESTIGATOR)
Mathew Angelos, MD (SUB_INVESTIGATOR)
Jorge Monge Urrea, MD (SUB_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Universtiy of Colorado Hospital· Aurora, CO

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