A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients With Relapsed Or Refractory T-Cell Acute Lymphoblastic Leukemia And Lymphomas
M.D. Anderson Cancer Center
Summary
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
Description
Primary Objective: • To determine the safety and tolerability of the combination of Venetoclax, Dexamethasone, Bortezomib, and Daratumumab for adolescent and young adult patients with Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) or Lymphoma (LBL). Secondary Objectives: * To conduct a preliminary assessment of efficacy in adolescent and young adult patients treated with this combination based on: * Best overall response (BOR), including complete remission (CR), CR with partial hematological recovery (CRh), CR with incomplete blood count recovery (Cri), morphologic free…
Eligibility
- Age range
- 12–30 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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) * Baseline ejection fraction must be \> 40% OR Shortening fraction \>20%. Either can be used at the investigator's discretion. * Adequate hepatic function (direct bilirubin \< 1.5x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement, and AST and/or ALT \< 5x ULN unless cons…
Interventions
- DrugVenetoclax
Given by mouth
- DrugDexamethasone
Given by mouth or IV
- DrugBortezomib
Given subcutaneously or IV
- DrugDaratumumab
Given by IV
Location
- UT MD AndersonHouston, Texas