RecruitingPhase 1NCT03595917

ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML

A Phase 1 Study of ABL001 in Combination With Dasatinib, Prednisone, and Blinatumomab in Patients With BCR-ABL Positive (BCR-ABL+) B-cell Acute Lymphoblastic Leukemia (B-ALL) and Chronic Myeloid Leukemia (CML)


Sponsor

Marlise Luskin, MD

Enrollment

40 participants

Start Date

Jul 24, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

This research study is evaluating a drug called ABL001 taken in combination with dasatinib (Sprycel®) and prednisone (a steroid) as a possible treatment for B-cell Acute Lymphoblastic Leukemia that is BCR-ABL positive (BCR-ABL+ B-ALL) or Chronic Myeloid Leukemia (CML) in lymphoid blast crisis. BCR-ABL+ B-ALL is also called Philadelphia chromosome positive Acute Lymphoblastic Leukemia (Ph+ ALL). It is expected that 40-65 people will take part in this research study. * ABL001 * Dasatinib (Sprycel®) * Prednisone * Blinatumomab


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of four drugs — including two targeted drugs that attack a specific cancer gene mutation (BCR-ABL) and an immunotherapy drug — for people with a type of aggressive leukemia called BCR-ABL positive acute lymphoblastic leukemia (ALL) or a blast crisis phase of chronic myeloid leukemia (CML). **You may be eligible if...** - You have been diagnosed with BCR-ABL positive acute leukemia (a type that has the Philadelphia chromosome mutation) - You are not suitable for, or do not want, standard intensive chemotherapy (for the dose-finding phase) - You are 18 years or older (for the dose expansion phase) - You have cancer cells that are CD19-positive **You may NOT be eligible if...** - You have active, serious infections - You have a history of severe allergic reactions to the drugs used - You have uncontrolled heart disease - You are pregnant or breastfeeding 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

DRUGABL001

•ABL001 is administered daily per 28 day cycle

DRUGDasatinib

Fixed doses oral once a day per 28 day cycle

DRUGPrednisone

Fixed doses oral once a day per 28 day cycle Prednisone will be tapered and stop during cycle 2.

DRUGBlinatumomab

By intravenous continuous infusion beginning no earlier than cycle 2 day 1 of protocol therapy Day 1-28 of each 42-day cycle, cycles 2-6, total of 5 cycles


Locations(4)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

View Full Details on ClinicalTrials.gov

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NCT03595917


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