Trial of Cladribine and Low-Dose Cytarabine (LoDAC) Alternating With Decitabine vs. Hypomethylating Agents (HMA) Plus Venetoclax as Frontline Therapy for AML or High-Grade MDS in Patients Unfit for Intensive Induction

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT05766514
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Cladribine — DRUG
    Subjects will be given 5 mg/m2 cladribine intravenously on days 1-5 of cycle 1 and on days 1-3 of cycles 2, 5, 6, 9, 10, 13, 14, 17 and 18.
  • Cytarabine — DRUG
    Subjects will be given 20 mg cytarabine subcutaneously twice daily on days 1-10 of cycles 1, 2, 5, 6, 9, 10, 13, 14, 17 and 18.
  • Decitabine — DRUG
    Subjects will be given 20 mg/m2 decitabine intravenously on days 1-5 of cycles 3, 4, 7, 8, 11, 12, 15 and 16
  • azacitidine or decitabine — DRUG
    Subjects will be given either 20 mg/m2 decitabine intravenously on days 1-5 of each cycle or 75 mg/m2 azacitidine intravenously or subcutaneously on days 1-7 of each cycle. The treating physician will determine which drug each subject will receive.
  • Venetoclax — DRUG
    Subject will take 400 mg venetoclax orally once daily on days 1-21 of each cycle.

Study Details

This phase II, open-label, randomized trial will compare the efficacy of the novel regimen of cladribine/low-dose cytarabine alternating with decitabine to the current standard of care regimen of hypomethylating agents (decitabine or azacitidine) plus venetoclax in patients with acute myeloid leukemia (AML) or high-grade myelodysplastic syndrome (MDS) who are either elderly or unfit for intensive induction. Subjects will be randomized to be treated with either cladribine/low-dose cytarabine alternating with decitabine (Arm A) or decitabine or azacitadine plus venetoclax (Arm B).

Key Dates

Start date
Apr 30, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

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

Arms

  • Experimental: Arm A (investigational arm): cladribine, cytarabine, and decitabine
  • Active Comparator: Arm B (control arm): azacitidine with venetoclax or decitabine with venetoclax

Primary Outcome Measure

Rate of complete remission [ Time Frame: 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32608-

Find similar trials in Gainesville, FL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Florida· Gainesville, FL

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