Actively Recruiting
Venetoclax Basket Trial for High Risk Hematologic Malignancies
Led by Andrew E. Place, MD · Updated on 2026-03-12
30
Participants Needed
5
Research Sites
378 weeks
Total Duration
On this page
Sponsors
A
Andrew E. Place, MD
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial is evaluating the safety and tolerability of venetoclax with chemotherapy in pediatric and young adult patients with hematologic malignancies, including myelodysplastic syndrome (MDS), acute myeloid leukemia derived from myelodysplastic syndrome (MDS/AML), and acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LBL). The names of the study drugs involved in this study are below. Please note this is a list for the study as a whole, participants will receive drugs according to disease cohort. * Venetoclax * Azacitidine * Cytarabine * Methotrexate * Hydrocortisone * Leucovorin * Dexamethasone * Vincristine * Doxorubicin * Dexrazoxane * Calaspargase pegol * Hydrocortisone
CONDITIONS
Official Title
Venetoclax Basket Trial for High Risk Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of MDS, AML arising from MDS, or therapy-related myeloid neoplasms meeting specified disease criteria
- Diagnosis of relapsed or refractory B-cell or T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma with defined disease features
- Age 1 to 40 years depending on cohort, with some restrictions for untreated cases
- Lansky or Karnofsky performance status of 50% or higher
- Fully recovered from acute toxic effects of prior therapies including chemotherapy, immunotherapy, or radiation
- Adequate organ function as defined by liver enzymes, bilirubin, and cardiac function
- Female participants of childbearing potential must have negative pregnancy tests and agree to use effective contraception
- No evidence of graft-versus-host disease if prior hematopoietic stem cell transplant received
You will not qualify if you...
- Use of strong or moderate CYP3A inhibitors or inducers within 3 days of study entry
- Ongoing treatment for or evidence of graft-versus-host disease after stem cell transplant
- Known active hepatitis or active systemic infections not improving with treatment
- Known HIV infection
- Pregnant or nursing women
- Significant concurrent disease, psychiatric disorder, or social issues that compromise safety or compliance
- History of allergic reactions to study agents except certain asparaginase formulations for Cohort C
- History of asparaginase-associated pancreatitis or active deep venous thrombosis
- Isolated central nervous system or testicular relapse in Cohort C
- Presence of specific genetic markers or prior malignancies unless meeting defined exceptions
AI-Screening
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Trial Site Locations
Total: 5 locations
1
University of California San Francisco-Benioff Children's Hospital
San Francisco, California, United States, 94158
Actively Recruiting
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Children's Healthcare of Atlanta at Arthur M. Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
4
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
A
Andrew E Place, MD, PhD
CONTACT
J
Jessica A Pollard, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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