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RECRUITING
NCT04872790
PHASE1

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

Sponsor: OHSU Knight Cancer Institute

View on ClinicalTrials.gov

Summary

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.

Official title: A Dose-Finding Phase Ib Study of the Oral BCL-2 Inhibitor Venetoclax (ABT-199) in Combination With Standard Induction Therapy, Dasatinib and Prednisone (and Rituximab in CD20+ Patients), in Adult Patients With Newly Diagnosed and Relapsed Philadelphia Chromosome Positive (Ph+) ALL and Ph+ MPAL

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2022-09-02

Completion Date

2026-12-02

Last Updated

2026-02-10

Healthy Volunteers

No

Interventions

DRUG

Dasatinib

Given PO

DRUG

Methotrexate

Given IT

DRUG

Prednisone

Given PO

BIOLOGICAL

Rituximab

Given IV

DRUG

Venetoclax

Given PO

BIOLOGICAL

Blinatumomab

Given IV

PROCEDURE

Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Locations (1)

OHSU Knight Cancer Institute

Portland, Oregon, United States