Venetoclax + Dexamethasone + Bortezomib + Daratumumab for T-Cell Leukemia

Overseen By Miriam B Garcia, DO

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Anticancer agents

Disqualifiers: Uncontrolled medical condition, Active infection, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Miriam B Garcia, DOp

Principal Investigator

UT MD Anderson

Are You a Good Fit for This Trial?

Inclusion Criteria

I have relapsed or refractory T-ALL or TLBL confirmed by biopsy or lab tests.

Patients may have received any of the study agents prior to enrollment if not previously provided in study combination

Approved methods of birth control include hormonal contraception, intrauterine device (IUD), tubal ligation or hysterectomy, partner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide

Exclusion Criteria

I am currently pregnant or breastfeeding.

I am not taking other chemotherapy or anti-leukemia drugs during the study.

History of or any concurrent condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation, or is not in the best interest of the patient to participate

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Venetoclax, Dexamethasone, Bortezomib, and Daratumumab

1 year

Cycle 1 day 1, day 1 visits for each new cycle, end-of-treatment visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bortezomib
• Daratumumab
• Dexamethasone
• Venetoclax

How Is the Trial Designed?

Group I: Treatment with Venetoclax, Dexamethasone, Bortezomib, and Daratumumab (VDBD) Experimental Treatment 4 Interventions

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).

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+