RecruitingPhase 1NCT04872790

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

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


Sponsor

OHSU Knight Cancer Institute

Enrollment

20 participants

Start Date

Sep 2, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of targeted drugs — venetoclax, dasatinib, prednisone, rituximab, and blinatumomab — for adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), a type of leukemia with a specific genetic change that makes it harder to treat. The goal is to achieve deep remission without traditional intensive chemotherapy. **You may be eligible if...** - You have been diagnosed with Ph+ ALL or Ph+ mixed-phenotype acute leukemia confirmed by bone marrow biopsy - You are newly diagnosed (with no or minimal prior treatment) or your leukemia has relapsed - Your cancer cells express CD19 (especially if you have had prior CAR-T therapy) - You have not previously been treated with dasatinib (other TKI drugs are allowed) **You may NOT be eligible if...** - Your leukemia does not have the Philadelphia chromosome - You have previously received dasatinib - Your CD19 levels are too low (if you've had prior CAR-T therapy) - You have recently taken strong CYP3A-inhibiting medications and not waited the required washout period Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDasatinib

Given PO

DRUGMethotrexate

Given IT

DRUGPrednisone

Given PO

BIOLOGICALRituximab

Given IV

DRUGVenetoclax

Given PO

BIOLOGICALBlinatumomab

Given IV

PROCEDUREBone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

PROCEDURELumbar Puncture

Undergo lumbar puncture

PROCEDUREBiospecimen Collection

Undergo blood sample collection


Locations(1)

OHSU Knight Cancer Institute

Portland, Oregon, United States

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NCT04872790


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