Actively Recruiting
A Phase 2 Study to Evaluate Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia and T-Cell Lymphoblastic Lymphoma
Led by M.D. Anderson Cancer Center · Updated on 2026-03-16
22
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the combination of calaspargase pegol-mknl, decitabine, and venetoclax in pediatric, adolescent, and young adult patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LLy). This phase 2 study aims to evaluate how well this drug combination controls the disease and to assess its safety by monitoring adverse events as patients undergo treatment. The study involves giving calaspargase pegol-mknl and decitabine intravenously, while venetoclax is taken by mouth. Patients receive this treatment combination during the study period, with specific dosing schedules managed by the research team. The treatment is followed by monitoring for response, including the possibility of proceeding to hematopoietic stem cell transplant (HSCT) if appropriate. Researchers will also study drug effects related to pharmacokinetics and genetic markers associated with the disease. Participants will be closely monitored through clinical evaluations, laboratory tests, and assessments of disease response, including minimal residual disease (MRD) status. Safety is tracked throughout the study, which lasts on average about one year. The research team measures outcomes such as complete response rate, overall survival, event-free survival, and adverse events. The study also investigates how patients transition to HSCT and the impact of antibodies on treatment outcomes.
CONDITIONS
Brief 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 lymphoma
- Adequate performance status: ECOG ≤2 for patients 16 years or older, Lansky score >50 for patients under 16 years
- Age between 1 month and 21 years at the time of consent
- Patients with asymptomatic central nervous system disease are eligible
- Conditions requiring systemic glucocorticoid use, controlled graft versus host disease, or severe asthma are allowed
- Adequate organ function and lab results within 14 days of enrollment, including bilirubin, renal function, liver enzymes, amylase, lipase, and triglycerides within specified limits
- Females of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 3 months after
- Males must use condoms during the study and for 90 days after treatment and notify doctor if partner becomes pregnant
- At least 30 days must have passed since prior hematopoietic stem cell transplant
- Ability and willingness to swallow tablets or oral dispersible tablets
You will not qualify if you...
- History of secondary or other primary tumors except certain treated cancers with no active disease
- Uncontrolled central nervous system conditions such as epilepsy or severe brain injuries
- Major surgery or significant injury within 14 days before dosing
- Unwillingness to use approved contraception methods
- Uncontrolled infections
- Significant cardiac disease including severe heart failure or arrhythmia requiring medication
- Pregnancy or breastfeeding; planning pregnancy during or shortly after the study period
- Enrollment in another clinical trial with investigational products
- Liver cirrhosis or severe active liver disease
- Inability or unwillingness to comply with study procedures
- Incomplete recovery from prior therapy toxicities except certain neuropathies
- Grade 3 or 4 pancreatitis or history of severe reactions to asparaginase
- Severe uncontrolled medical or psychiatric conditions that increase risk or interfere with study
- History of serious hypersensitivity to pegylated L-Asparaginase
- Known coagulopathy or active thromboembolic events
- Use of strong or moderate CYP3A inducers within 7 days before first dose
- Malabsorption syndrome or conditions preventing oral drug administration
- Recent use of grapefruit, star fruit, or strong CYP3A inhibitors before first dose of venetoclax
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year
Participants receive Calaspargase pegol-mknl, Decitabine, and Venetoclax as part of the study treatment.
Visits scheduled according to treatment cycles (exact frequency not specified)
Duration - Through study completion; an average of 1 year
Participants are monitored for safety and adverse events after treatment completion.
Visit frequency determined by study protocol (not specified)
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77090
Actively Recruiting
Research Team
D
David McCall, MD
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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