RecruitingPhase 1Phase 2NCT03319901

Venetoclax and Chemotherapy as Frontline Therapy in Older Patients and Patients With Relapsed/Refractory ALL

A Phase Ib Study of the Combination of Venetoclax With Chemotherapy as Frontline Therapy in Older Patients and Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia


Sponsor

Dana-Farber Cancer Institute

Enrollment

82 participants

Start Date

Oct 30, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

This research study is studying a medication called Venetoclax and a chemotherapy regimen as a possible treatment for Acute Lymphoblastic Leukemia. The drugs involved in this study are: * Venetoclax * Standard Chemotherapy (which includes cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, 6-mercaptopurine, etoposide, and cytarabine


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding venetoclax — a drug that helps trigger cancer cell death — to standard chemotherapy improves outcomes for older adults with newly diagnosed acute lymphoblastic leukemia (ALL), or for any adult whose ALL has returned or stopped responding to treatment. **You may be eligible if...** - You have ALL (a type of blood cancer) that has never been treated AND you are 60 years or older - OR you have ALL that has come back or stopped responding to prior treatment (any age) - Your bone marrow has at least 20% leukemia cells - Your organ function is adequate for chemotherapy **You may NOT be eligible if...** - Your leukemia is a different type (e.g., AML) - Your organ function is too poor to tolerate chemotherapy - You have active, uncontrolled infection 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

DRUGVenetoclax

Venetoclax is an inhibitor of Bcl-2. Bcl-2 is critical for keeping cancer cells alive. By inhibiting Bcl-2, venetoclax promotes cancer cell death.

DRUGStandard Chemotherapy

Standard treatment of chemotherapy is administered


Locations(5)

University of Chicago

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

MD Anderson Cancer Center

Houston, Texas, United States

Intermountain LDS Hospital

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT03319901


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