Venetoclax + Chemotherapy for Acute Lymphoblastic Leukemia

Recruiting in Palo Alto (17 mi)

Jae Park, MD - MSK Leukemia Specialist ...

Overseen byJae Park, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing if adding venetoclax to standard chemotherapy is safe and effective for adults under 60 with newly diagnosed T- or B-cell acute lymphoblastic leukemia (ALL). Venetoclax helps chemotherapy work better by blocking a protein that keeps cancer cells alive. Venetoclax has shown promise in treating various forms of leukemia, including acute lymphoblastic leukemia (ALL), by enhancing the effectiveness of chemotherapy.

Eligibility Criteria

Adults aged 18-60 with newly diagnosed acute lymphoblastic leukemia (ALL), either T-cell or B-cell type, but without Philadelphia chromosome positive status. Participants must have good performance status, adequate kidney and liver function, and no active heart disease or other cancers. Pregnant women are excluded, and effective contraception is required.

Inclusion Criteria

I am able to get out of my bed or chair and move around.

I am between 18 and 60 years old.

My liver is functioning well, with specific blood test levels within acceptable ranges.

+5 more

Exclusion Criteria

I don't have any active cancer needing treatment, except for minor skin cancers or cancers I've been free of for 5 years.

I haven't had a heart attack, stroke, or severe heart issues in the last 6 months.

I do not have HIV, hepatitis B, or hepatitis C.

+4 more

Participant Groups

The trial tests the safety and effectiveness of Venetoclax combined with standard chemotherapy in treating adults with newly diagnosed ALL. The goal is to determine if this combination improves outcomes compared to traditional treatments alone.

1Treatment groups

Experimental Treatment

Group I: Venetoclax in Combination With ChemotherapyExperimental Treatment1 Intervention

All patients will complete Induction I and II of the treatment regimens, consisting of several chemotherapy agents including Peg-ASP.

Venetoclax is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Venclexta for: