A Study of Venetoclax in Combination With Chemotherapy to Treat Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

NCT05386576 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 21-372
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers are doing this study to find out whether combining venetoclax with several different standard chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) in children is safe and effective in adults with newly diagnosed ALL. Participants in this study will be under the age of 60, and they will have T- or B-cell ALL.

Conditions

Acute Lymphoblastic Leukemia

Keywords

Venetoclax; 21-372

Outcome Measures

Primary Outcomes (1)

• proportion of patients who have a Dose Limiting Toxicities

  up to 6 weeks

Study Arms (1)

Venetoclax in Combination With Chemotherapy

EXPERIMENTAL

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

Drug: Venetoclax

Interventions

Venetoclax DRUG

During Induction I, for patients on Dose Level 1, venetoclax will be administered at a dose of 100mg on day 5, 200mg on day 6 and 400mg on days 7-28. For patients on Dose Level 01, venetoclax will be administered at a dose of 100mg on day 5 and 200mg on days 6-28. During Induction II, venetoclax will be administered at either 400mg daily (Dose Level 1) or 200mg daily (Dose Level -1) from days 1-14 and 29-42.

Venetoclax in Combination With Chemotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients with newly diagnosed Philadelphia chromosome (Ph) negative ALL.
• Patients with T- or B-cell lymphoblastic lymphoma with no bone marrow involvement will also be eligible for the study.
• Age 18-60
• ECOG performance status of 0-2
• Adequate renal function as demonstrated by a calculated creatinine clearance of ≥ 60 ml/min.
• Adequate hepatic function as demonstrated by a total bilirubin ≤ 2.0 mg/dl (unless attributable to Gilbert's disease) and an alkaline phosphatase, AST, and ALT ≤ 4 times the upper limit of normal (unless clinically considered to be related to liver involvement with leukemia)
• Patients with central nervous system (CNS) involvement by ALL are eligible and may receive concomitant treatment with radiation therapy and/or intrathecal chemotherapy in accordance with standard medical practice. For patients with CNS disease, dexamethasone may be temporarily administered instead of prednisone to reduce CNS pressure, at the discretion of the treating physician and after discussion with the MSK PI. Once dexamethasone is no longer needed, prednisone should be given as per protocol for 28 days.
• Negative serum pregnancy test in women of childbearing potential

You may not qualify if:

• CML in lymphoid blast crisis, mature B-cell (i.e. Burkitt's) lymphoma or mixed phenotype acute leukemia (MPAL)
• Prior treatments for ALL, except any doses of corticosteroids and hydroxyurea or one dose of vincristine
• Patients who received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment
• Unstable angina and/or MI or stroke within 6 months prior to screening, and/or impaired cardiac function with EF \<40% or NYHA class III/IV
• Pregnant or lactating women. Women and men of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished.
• Patients with HIV or active hepatitis B or hepatitis C infection are ineligible.
• Patients with concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of the skin, in situ cervical cancer, adequately treated stage I/II cancer from which the patient is current in complete remission, or any other cancer from which the patient has been disease free for five years.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jae Park, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a phase I single-arm, single-center study.

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 23, 2022
• Study Start: June 16, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)