Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML

Part of paid clinical trials in Miami, Florida.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT06504459
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Azacitidine — DRUG
    Given IV or SC
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Cladribine — DRUG
    Given IV
  • Cytarabine — DRUG
    Given SC
  • Echocardiography — PROCEDURE
    Undergo ECHO
  • Lumbar Puncture — PROCEDURE
    Undergo LP
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Venetoclax — DRUG
    Given PO

Study Details

This phase II trial tests how well venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax works in treating patients with newly diagnosed monocytic acute myeloid leukemia (AML) and active signaling mutated AML. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as cladribine, cytarabine and azacitidine, 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. Giving venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax may kill more cancer cells in patients with newly diagnosed monocytic AML and active signaling mutated AML.

Key Dates

Start date
Jan 3, 2025
Status verified
Apr 2026
Primary completion
Oct 11, 2027
Completion
May 1, 2028

Study Design

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

Arms

  • Experimental: Treatment (venetoclax, cladribine, cytarabine, azacitidine)
    See Detailed Description

Primary Outcome Measure

Composite complete remission (CRc) rate [ Time Frame: At start of treatment to post-induction disease assessment (Cycle 1 Day 21 or Cycle 2 Day 21. Each cycle is 28 days) ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136
Justin Watts, MD
[email protected]
305-243-8986
OHSU Knight Cancer InstitutePortlandOregon97239
Curtis A. Lachowiez
[email protected]
503-494-6157
Curtis A. Lachowiez (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Miami Miller School of Medicine-Sylvester Cancer Center· Miami, FLOHSU Knight Cancer Institute· Portland, OR

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