RecruitingPhase 1NCT05157971

Venetoclax and a Pediatric-Inspired Regimen for the Treatment of Newly Diagnosed B Cell Acute Lymphoblastic Leukemia

A Phase 1 Study Combining Venetoclax With a Pediatric-Inspired Regimen for Newly Diagnosed Adults With B Cell Ph-Like Acute Lymphoblastic Leukemia

Sponsor

City of Hope Medical Center

Enrollment

24 participants

Start Date

Mar 17, 2022

Study Type

INTERVENTIONAL

Conditions

B Acute Lymphoblastic Leukemia Ph-Like Acute Lymphoblastic Leukemia

Summary

This phase I trial tests the safety, side effects, and best dose of venetoclax in combination with a pediatric-inspired chemotherapy regimen known as C10403 in treating patients with newly diagnosed B cell acute lymphoblastic leukemia. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. The C10403 regimen is composed of the chemotherapy drugs cytarabine, cyclophosphamide, daunorubicin, mercaptopurine, pegaspargase, vincristine, and methotrexate, all which work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It also consists of prednisone, which is an anti-inflammatory drug that lowers the body's immune response and is used with other drugs in the treatment of some types of some types of cancer. This study may help researchers learn if adding venetoclax to the pediatric-inspired C10403 regimen can be tolerated and help treat older patients.

Eligibility

Min Age: 18 YearsMax Age: 54 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of venetoclax (a targeted cancer drug) with a chemotherapy regimen typically used in younger patients, for adults newly diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) — a fast-growing cancer of the blood and bone marrow. **You may be eligible if...** - You are 18–54 years old - You have been newly diagnosed with B-cell ALL confirmed by lab tests - You are in reasonably good health (ECOG score 0–2) - Your white blood cell count, liver, and kidney function are within acceptable levels - Your heart function is normal **You may NOT be eligible if...** - You have already received treatment for B-ALL - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding - You are unwilling to use contraception - You have active, uncontrolled infections 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

DRUGCyclophosphamide

Given IV

DRUGCytarabine

Given SC, IV or IT

DRUGDaunorubicin Hydrochloride

Given IV

DRUGMercaptopurine

Given PO

DRUGMethotrexate

Given IT

DRUGPegaspargase

Given IM or IV

DRUGPrednisone

Given PO

DRUGVenetoclax

Given PO

DRUGVincristine Sulfate

Given IV

Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT05157971

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