Actively Recruiting
A Phase I Study of Hyper-CVAD In Combination With Venetoclax In Pediatric Patients With Relapsed or Refractory Acute Leukemias That Are of the Lymphoid Lineage Including Bi-Phenotypic or Undifferentiated Leukemias
Led by M.D. Anderson Cancer Center · Updated on 2026-03-09
22
Participants Needed
1
Research Sites
358 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To find the recommended dose of hyper-CVAD in combination with venetoclax that can be given to participants with relapsed or refractory leukemia.
CONDITIONS
Official Title
A Phase I Study of Hyper-CVAD In Combination With Venetoclax In Pediatric Patients With Relapsed or Refractory Acute Leukemias That Are of the Lymphoid Lineage Including Bi-Phenotypic or Undifferentiated Leukemias
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric, adolescent, or young adult patients aged 2 to 21 years with relapsed or refractory acute leukemias of the lymphoid lineage including bi-phenotypic or undifferentiated leukemias
- At least 5% leukemic blasts in bone marrow or peripheral blood
- Adequate performance status: ECOG 0-2 for patients 16 years or older, Lansky score above 50 for patients under 16
- Patients with asymptomatic CNS disease are eligible
- Stable use of chronic systemic glucocorticoids (≤11.6 mg/m2 prednisone daily) allowed, with certain dosing adjustments during dexamethasone cycles
- Allowed concurrent use of hydroxyurea and low dose cytarabine (up to 2 gm/m2)
- At least 2 weeks or 5 half-lives from prior therapy (except hydroxyurea, glucocorticoids, or low dose cytarabine)
- Adequate organ function and lab results within 14 days before enrollment
- Negative pregnancy test for females of childbearing potential and agreement to use effective contraception
- Males must agree to use contraception during and for 4 months after study
- At least 30 days since prior hematopoietic stem cell transplant
- Controlled or treated hepatitis B or C infection as specified
- Ability to understand and sign informed consent
- Participants with CD19+ B-ALL must have received CD19-directed therapy prior to enrollment
You will not qualify if you...
- History of secondary or other primary tumors except certain treated cancers
- Uncontrolled CNS pathology such as epilepsy, severe brain injuries, psychosis
- Major surgery or significant traumatic injury within 14 days before dosing
- Uncontrolled infections
- Significant cardiac disease including CHF class III/IV, arrhythmia requiring medication, or cardiomyopathy
- Pregnant or lactating females
- Current enrollment in another clinical trial with investigational products
- Severe liver disease or suspected alcohol abuse
- Inability or unwillingness to comply with study procedures
- Not recovered from previous chemotherapy, surgery, or radiation before study start
- Severe uncontrolled medical or psychiatric conditions increasing risk or interfering with study
- Active or uncontrolled HIV infection or use of contraindicated HIV medications
- History of allergic reactions to similar agents used in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
David McCall, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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