NCT07513129

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 12 Years – 30 Years
• Healthy volunteers: Not accepted

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

Detailed description

Primary Objective: • To determine the safety, tolerability, and 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 Ojbectives: * 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 state (MLFS), partial remission (PR), stable disease (SD), and progressive disease (PD) * Time-to-event outcomes: overall survival (OS), event-free survival (EFS), and duration of response (DOR) * Composite remission rate (CRc), defined as CR, CRh, CRi, and MLFS

Conditions

• T-cell Acute Lymphoblastic Leukemia
• Lymphoma

Interventions

Type	Name	Description
DRUG	Venetoclax	Given by mouth
DRUG	Dexamethasone	Given by mouth or IV
DRUG	Bortezomib	Given subcutaneously or IV
DRUG	Daratumumab	Given by IV

Timeline

• Start date: 2026-09-01
• Primary completion: 2029-12-31
• Completion: 2031-12-31
• First posted: 2026-04-06
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study