Venetoclax + Chemotherapy for Acute Lymphoblastic Leukemia

Overseen By Mark Geyer, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: CYP3A inducers

Disqualifiers: CML, HIV, Hepatitis B/C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

12 Participants Needed

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.

Research Team

Jae Park, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

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.

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

I have ALL with CNS involvement and can get additional treatments for it.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction I

Participants receive venetoclax and chemotherapy agents including Peg-ASP. Venetoclax dosing varies by dose level.

28 days

Multiple visits for treatment and monitoring

Induction II

Continuation of venetoclax and chemotherapy treatment. Venetoclax dosing varies by dose level.

42 days

Multiple visits for treatment and monitoring

Consolidation

Includes 2 Intensification blocks and 2 Re-Induction blocks with venetoclax and chemotherapy agents.

130 days

Multiple visits for treatment and monitoring

Maintenance

Participants receive a 4-drug regimen for 2 years. No venetoclax is administered during this phase.

2 years

Bone marrow aspirate and biopsy every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Venetoclax

Trial Overview 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.

Participant Groups

Group I: Venetoclax in Combination With Chemotherapy Experimental Treatment 1 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:

• Chronic lymphocytic leukemia (CLL)
• Small lymphocytic lymphoma (SLL)
• Acute myeloid leukemia (AML)

Approved in European Union as Venclyxto for:

• Chronic lymphocytic leukemia (CLL)
• Small lymphocytic lymphoma (SLL)
• Acute myeloid leukemia (AML)

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD