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

NCT07513129 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2025-1869NCI-2026-02416
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

T-cell Acute Lymphoblastic Leukemia; Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion; an average of 1 year

Study Arms (1)

Treatment with Venetoclax, Dexamethasone, Bortezomib, and Daratumumab (VDBD)

EXPERIMENTAL

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).

Drug: Venetoclax; Drug: Dexamethasone; Drug: Bortezomib; Drug: Daratumumab

Interventions

Venetoclax DRUG

Given by mouth

Also known as: Venclexta

Treatment with Venetoclax, Dexamethasone, Bortezomib, and Daratumumab (VDBD)

Dexamethasone DRUG

Given by mouth or IV

Treatment with Venetoclax, Dexamethasone, Bortezomib, and Daratumumab (VDBD)

Bortezomib DRUG

Given subcutaneously or IV

Also known as: Velcade

Treatment with Venetoclax, Dexamethasone, Bortezomib, and Daratumumab (VDBD)

Daratumumab DRUG

Given by IV

Also known as: Darzalex, Darzalex Faspro

Treatment with Venetoclax, Dexamethasone, Bortezomib, and Daratumumab (VDBD)

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 considered due to leukemic involvement, in which case direct bilirubin \< 3x ULN or AST and/or ALT \< 10x ULN will be considered eligible.
• Adequate renal function (calculated creatinine clearance ≥ 30 mL/min) unless related to disease as determined by PI.
• In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 14 days for cytotoxic or non-cytotoxic (immunotherapy agent(s), or an interval of 5 half-lives of the prior therapy (whichever is shorter). Hydroxyurea and/or cytarabine (up to 2 g/m2) for patients with rapidly proliferative disease is allowed before the start of study therapy, as needed, for clinical benefit and after discussion with the PI.
• Concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted.
• Patients may have received any of the study agents prior to enrollment in study if not previously provided in study combination.
• For patients with history or evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured.
• For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of active progression.
• Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better as determined by PI.

You may not qualify if:

• 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.
• The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions:
• i. intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia.
• Previous CNS evaluation and intrathecal (IT) chemotherapy administered prior to consent can be considered as the Cycle 1 Day 1 IT chemotherapy, provided it was completed within 7 days of C1D1. ii. use of hydroxyurea or cytarabine for patients with rapidly proliferative disease.
• iii. use of steroids for treatment of rapidly proliferative disease. iv. Investigational or commercial agent for supportive care may be used in consultation with the treating physician.
• 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.
• Patients with a concurrent second active malignancy under treatment.
• Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection.
• Testing is not required for patients without a known or suspected history.
• Female subjects who are pregnant or breast-feeding.
• Patient has an infection that is both active and uncontrolled.
• History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition venetoclax, dexamethasone, bortezomib, daratumumab.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma

Interventions

venetoclax; Dexamethasone; Bortezomib; daratumumab

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Miriam B Garcia, DOp

  UT MD Anderson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miriam B Garcia, DO

CONTACT

(713) 745-4312; mbgarcia@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start: June 5, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2031
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

US (1)