Venetoclax, Dexamethasone, Bortezomib, and Daratumumab For The Treatment Of Adolescent And Young Adults With Relapsed Or Refractory T-Cell Acute Lymphoblastic Leukemia And T-cell Acute Lymphoblastic Lymphoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07513129
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Lymphoma
  • T-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
12 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Given by mouth
  • Dexamethasone — DRUG
    Given by mouth or IV
  • Bortezomib — DRUG
    Given subcutaneously or IV
  • Daratumumab — DRUG
    Given by IV

Study Details

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

Key Dates

Start date
Sep 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2031

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with Venetoclax, Dexamethasone, Bortezomib, and Daratumumab (VDBD)
    All participants must complete a screening clinic visit, cycle 1 day 1 (- 28 days), day 1 visits for each new cycle (- 7 days), and an end-of-treatment visit (- 7 days).

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD AndersonHoustonTexas77030
Miriam B Garcia, DO
[email protected]
713-745-4312
Miriam B Garcia, DO (PRINCIPAL_INVESTIGATOR)

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By research site
UT MD Anderson· Houston, TX

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