Venetoclax, Dasatinib, Prednisone, Rituximab and Blinatumomab for the Treatment of Newly Diagnosed or Relapsed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT04872790
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • B Acute Lymphoblastic Leukemia
  • B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
  • Mixed Phenotype Acute Leukemia
  • Recurrent B Acute Lymphoblastic Leukemia
  • Recurrent Mixed Phenotype Acute Leukemia

Eligibility Criteria

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

Interventions

  • Dasatinib — DRUG
    Given PO
  • Methotrexate — DRUG
    Given IT
  • Prednisone — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV
  • Venetoclax — DRUG
    Given PO
  • Blinatumomab — BIOLOGICAL
    Given IV
  • Bone Marrow Aspiration and Biopsy — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Lumbar Puncture — PROCEDURE
    Undergo lumbar puncture
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection

Study Details

This phase Ib trial studies the effects of venetoclax in combination with dasatinib, prednisone, rituximab and blinatumomab in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia (ALL) that is newly diagnosed or that has come back (relapsed). Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Rituximab and blinatumomab are monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving venetoclax in combination with dasatinib, prednisone, and rituximab and blinatumomab may help treat patients with newly diagnosed or relapsed Philadelphia chromosome positive acute lymphoblastic leukemia.

Key Dates

Start date
Sep 2, 2022
Status verified
May 2026
Primary completion
Dec 2, 2027
Completion
Dec 2, 2027

Study Design

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

Arms

  • Experimental: Treatment (prednisone, dasatinib, venetoclax, rituximab)
    See detailed description

Primary Outcome Measure

Incidence of dose-limiting toxicities [ Time Frame: At day 32 (after 30 days of combination therapy) ]

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239-

Find similar trials in Portland, OR

By research site
OHSU Knight Cancer Institute· Portland, OR

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