Actively Recruiting
Venetoclax and Chemotherapy as Frontline Therapy in Older Patients and Patients With Relapsed/Refractory ALL
Led by Dana-Farber Cancer Institute · Updated on 2025-06-05
82
Participants Needed
5
Research Sites
495 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study is studying a medication called Venetoclax and a chemotherapy regimen as a possible treatment for Acute Lymphoblastic Leukemia. The drugs involved in this study are: * Venetoclax * Standard Chemotherapy (which includes cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, 6-mercaptopurine, etoposide, and cytarabine
CONDITIONS
Official Title
Venetoclax and Chemotherapy as Frontline Therapy in Older Patients and Patients With Relapsed/Refractory ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with previously untreated acute lymphoblastic leukemia (B-cell or T-cell)
- Bone marrow involvement with �3e=20% lymphoblasts
- Age �3e= 60 years
- Patients with relapsed or refractory acute lymphoblastic leukemia (B-cell or T-cell) who have received one or more cytotoxic regimens
- Bone marrow involvement with �3e=5% lymphoblasts
- Age �3e= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status �3c=2
- Adequate organ function including:
- Serum total bilirubin �3c=1.5 x upper limit of normal (ULN) or �3c=3 x ULN for patients with Gilbert's disease
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) �3c=3.0 x ULN unless due to disease involvement
- Creatinine clearance >50 mL/min (per institutional standards or Cockcroft-Gault or MDRD formula)
- Women of childbearing potential must have a negative pregnancy test within 14 days before the first dose and agree to use effective contraception during and 30 days after treatment
- Men with partners of childbearing potential must agree to use effective contraception during and 30 days after treatment
- Patients or their legally authorized representatives must provide informed consent
You will not qualify if you...
- Philadelphia chromosome-positive (Ph-positive) ALL, Burkitt's leukemia/lymphoma, or lymphoblastic lymphoma
- Pregnant or breastfeeding women
- Patients with uncontrolled infections
- Hepatitis B or C infection or known HIV seropositivity
- Major surgery or radiation therapy within 4 weeks before first study dose
- Systemic chemotherapy, radiotherapy, or investigational therapy within 14 days before starting therapy (except hydroxyurea/dexamethasone or one dose of cytarabine)
- Symptomatic or untreated leptomeningeal disease or spinal cord compression
- Active heart disease (NYHA class 3-4), unstable angina, stroke, or myocardial infarction within the last 6 months
- Cardiac ejection fraction below 40%
- History of another primary invasive cancer not treated or in remission less than 2 years (except non-melanoma skin cancers or carcinomas in situ)
- Concurrent use of warfarin
- Use of CYP3A inhibitors or inducers within 3 days before starting venetoclax
- Consumption of grapefruit, grapefruit products, Seville oranges, or star fruit within 3 days before starting venetoclax
- Prior treatment with venetoclax
- Conditions preventing oral drug administration such as malabsorption syndrome
- Other severe medical or psychiatric conditions or lab abnormalities that increase risk or interfere with study participation or result interpretation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
5
Intermountain LDS Hospital
Salt Lake City, Utah, United States, 84143
Actively Recruiting
Research Team
M
Marlise Luskin, MD, MSCE
CONTACT
R
Rebecca Leonard
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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