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Venetoclax and Chemotherapy for Acute Lymphoblastic Leukemia

This study is testing Venetoclax, a medication that helps kill cancer cells by blocking a protein called Bcl-2, when given with standard chemotherapy. It's for people with Acute Lymphoblastic Leukemia (ALL), specifically those aged 60 or older who haven't had treatment before, or those aged 18 or older whose ALL has come back or hasn't responded to previous treatments. The main goal is to find the safest and most effective dose of Venetoclax when combined with chemotherapy. This is a Phase 1 study, meaning it's focused on safety and finding the right dose. The study is currently recruiting 82 participants.

Study design
This is a Phase 1 interventional study, which means it tests the safety and appropriate dose of Venetoclax and chemotherapy. It plans to enroll 82 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The maximum tolerated dose will be measured at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03319901

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Dana-Farber Cancer Institute
~82 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:VenetoclaxStandard Chemotherapy

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose
Measured over 2 years

Conditions

Leukemia

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Acute Lymphoblastic Leukemia

NCT03319901

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Dana Farber Cancer Institute

    Boston, Massachusettsno site contact published

  • Intermountain LDS Hospital

    Salt Lake City, Utahno site contact published

  • Massachusetts General Hospital

    Boston, Massachusettsno site contact published

  • MD Anderson Cancer Center

    Houston, Texasno site contact published

  • University of Chicago

    Chicago, Illinoisno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Marlise Luskin, MD, MSCE · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Patients with previously untreated acute lymphoblastic leukemia (B-cell or T-cell)
Bone marrow involvement with ≥20% lymphoblasts
Age ≥ 60 Years
Patients with relapsed or refractory acute lymphoblastic leukemia (B-cell or T-cell) defined as receiving one or more cytotoxic containing regimens
Bone marrow involvement with ≥5% lymphoblasts
Age ≥ 18 Years
Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Refer to Appendix D)
Adequate organ function
Serum total bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for patients with Gilbert's disease
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN, unless clearly due to disease involvement
Creatinine clearance \>50 mL/min (calculated according to institutional standards or using Cockcroft-Gault or Modification of Diet in Renal Disease (MDRD) formula)
Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-hCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug. Women of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. Men who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
Patients or their legally authorized representative must provide written informed consent

Exclusion

Ph-positive ALL, Burkitt's leukemia/lymphoma, or lymphoblastic lymphoma
Patient is pregnant or breastfeeding
Patients with uncontrolled infection
Hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV)
Major surgery or radiation therapy within 4 weeks prior to the first study dose
Systemic chemotherapy/radiotherapy/investigational therapy within 14 days (with the exception of hydroxyurea and/or dexamethasone, or one dose of cytarabine) prior to starting therapy
Symptomatic or untreated leptomeningeal disease or spinal cord compression
Patients with active heart disease (New York Heart Association (NYHA) class 3-4 as assessed by history and physical examination, unstable angina/stroke/myocardial infarction within the last 6 months)
Patients with a cardiac ejection fraction (as measured by either Multi Gated Acquisition (MUGA) or echocardiogram (EKG)) \<40%
History of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years. Patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses)
Concurrent use of warfarin
Received Cytochrome P450 3A (CYP3A) inhibitors (such as fluconazole, ketoconazole, voriconazole, and clarithromycin) within 3 days of starting venetoclax; received strong CYP3A inducers (such as rifampin, rifabutin, phenytoin, carbamazepine, and St. John's Wort) within 3 days of starting venetoclax
Consumed grapefruit, grapefruit products, Seville oranges, or star fruit within 3 days prior to starting venetoclax
Prior treatment with venetoclax
Malabsorption syndrome or other conditions that preclude enteral route of administration
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this study

What this trial measures

  • Maximum Tolerated Dose2 years

    To determine the maximum tolerated dose (MTD) of venetoclax in combination with chemotherapy in patients with newly diagnosed Acute Lymphoblastic Leukemia (ALL)