This is an open-label, single institution, Phase 1 study of Venetoclax, Dexamethasone, Bortezomib, and Daratumumab for adolescent and young adult participants with relapsed or refractory T-ALL or T-LBL
Weight must be > or = to 40 kg
Patients must have histologically or cytologically confirmed relapsed or refractory T-ALL or TLBL.
Age ≥ 12 year to ≤ 30 years.
Lansky ≥60 for patients <16, Karnofsky ≥60 for patients ≥ 16 years of age. (See Appendix I)
Patients with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment.
No investigational or commercial anti-cancer agents or therapies other than those described below may be administered with the intent to treat the patient's malignancy.
Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.
Patients with severe uncontrolled peripheral neuropathy significantly impairing motor or sensory function.
Single group
Venetoclax
DrugGiven by mouth
Dexamethasone
DrugGiven by mouth or IV
Bortezomib
DrugGiven subcutaneously or IV
Daratumumab
DrugGiven by IV
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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