Actively Recruiting
A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy)
Led by M.D. Anderson Cancer Center · Updated on 2026-03-16
22
Participants Needed
1
Research Sites
326 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn if giving the study drugs calaspargase pegol-mknl and decitabine in combination with venetoclax can help to control relapsed/refractory T-ALL and T-LLy. The safety of this drug combination will also be studied.
CONDITIONS
Official Title
A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric, adolescent, or young adult patients with relapsed or refractory T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma
- ECOG performance status ≤2 for patients 16 years or older, Lansky score >50 for patients younger than 16 years
- Age between 1 month and 21 years at time of consent
- Patients with asymptomatic central nervous system (CNS) disease are eligible
- Conditions requiring systemic glucocorticoid use (e.g., autoimmune disease, controlled graft versus host disease, severe asthma) are allowed
- Up to 5 days of glucocorticoids and limited doses of cyclophosphamide or cytarabine as pre-phase treatment are permitted
- Adequate organ function and lab results within 14 days before enrollment, including bilirubin, kidney function, liver enzymes, amylase, lipase, and triglycerides within allowed limits
- Females of childbearing potential must have a negative pregnancy test within 14 days before first dose and agree to use effective contraception during and 3 months after study
- Males must inform doctor if partner becomes pregnant and use condoms during study and for 90 days after last treatment
- At least 30 days since prior stem cell transplant before starting study drugs
- Ability and willingness to swallow tablets or oral dispersible tablets
You will not qualify if you...
- Past or current secondary or other primary tumors except for certain treated skin or solid tumors with no active disease for 2 years
- Uncontrolled CNS conditions such as epilepsy, paresis, aphasia, stroke, severe brain injury, organic brain syndrome, or psychosis
- Significant traumatic injury or major surgery within 14 days before first dosing
- Unwillingness to use effective contraception if of childbearing potential
- Uncontrolled infections as determined by the investigator
- History of significant cardiovascular disease including severe heart failure, arrhythmia requiring medication, or cardiomyopathy
- Pregnancy or breastfeeding, or planning pregnancy during and after study as specified
- Current enrollment in another clinical trial with investigational products
- Severe liver disease or cirrhosis, or suspected active alcohol abuse
- Inability or unwillingness to comply with study requirements
- Unrecovered grade 2 or higher toxicity from prior therapy except certain neuropathies
- Grade 3 or 4 pancreatitis or history of severe reactions to pegylated L-Asparaginase
- Known coagulopathy or active blood clots
- Use of strong or moderate CYP3A inducers within 7 days before first dose
- Malabsorption or conditions preventing oral drug administration
- Recent use of grapefruit, Seville oranges, star fruit, or CYP3A inhibitors within 2 days before first venetoclax dose
- Other severe uncontrolled medical or psychiatric conditions as judged by the investigator
- History of serious hypersensitivity to pegylated L-Asparaginase therapy
- Active thromboembolic events or history of CNS thromboses
- Male patients must not donate sperm during study and specified periods after treatment completion
- Females must not become pregnant during and for specified times after treatment completion
- Patients with pancreatitis grade 3 or higher or history of anaphylaxis to asparaginase are excluded
- Patients with malabsorption syndrome or other conditions that preclude oral drug intake are excluded
- Patients who have consumed grapefruit or similar products or used CYP3A inhibitors shortly before treatment are excluded
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, 77090
Actively Recruiting
Research Team
D
David McCall, MD
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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