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.
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.
Patients have adequate performance status (ECOG ≤2) for patients≥16 years old, Lansky score >50 for patients<16 years old.
Patients must be 1mo to 21 years of age at time of signing/or having proxy sign the informed consent.
Patients with asymptomatic CNS disease are eligible (see also Exclusion Criterion #2 in section 4.2.)
Presence of clinically significant uncontrolled CNS pathology such as epilepsy, paresis, aphasia, stroke, severe brain injuries, organic brain syndrome, or psychosis.
Significant traumatic injury or major surgery (major surgery means opening of a body cavity, e.g., thoracotomy, laparotomy, laparoscopic organ resection, and major orthopedic procedures, e.g. joint replacement, open reduction, and internal fixation) within 14 days of scheduled dosing day 1.
Male or female subjects of childbearing potential, unwilling to use an approved, effective means of contraception in accordance with institution's standards.
Patients with uncontrolled infections (viral, bacterial, or fungal) per PI's discretion. Infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable.
Single group
Decitabine
DrugGiven by vein
Venetoclax
DrugGiven by mouth
Calaspargase pegol-mknl
DrugGiven by vein
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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