M.D. Anderson Cancer Center
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.
Primary Objectives: To characterize the clinical efficacy of Calaspargase pegol-mknl and Decitabine in combination with Venetoclax in pediatric, adolescent, and young adult patients with relapsed/refractory T-ALL/T-LLy based upon the complete response rate (CR). Secondary Objectives: To summarize efficacy per response rate, overall survival (OS), event free survival (EFS), and minimal residual disease (MRD) negativity rate. To summarize the incidence, prevalence, and severity of adverse drug reactions according to common terminology criteria for adverse events (CTCAE) NCI CTCAE version 5.0…
Inclusion Criteria: 1. Pediatric, adolescent, or young adult patients who have relapse or refractory T-cell lymphoblastic leukemia (T-ALL) or T-Cell lymphoblastic lymphoma (T-LLy) according to 2017 WHO classification and NCCN v1 2021. 2. Patients have adequate performance status (ECOG ≤2) for patients≥16 years old, Lansky score \>50 for patients\<16 years old. 3. Patients must be 1mo to 21 years of age at time of signing/or having proxy sign the informed consent. 4. Patients with asymptomatic CNS disease are eligible (see also Exclusion Criterion #2 in section 4.2.) 5. The following condition…
Given by vein
Given by mouth
Given by vein
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