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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12-30
SponsorM.D. Anderson Cancer Center

About 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

Eligibility criteria

Qualifiers

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)

Disqualifiers

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.

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.

Trial design

Treatments tested in this trial

  • Venetoclax
  • Dexamethasone
  • Bortezomib
  • Daratumumab

Treatment groups

18 Participants
are divided into 1 treatment group

Locations

1
UT MD Anderson77030, HoustonTexas, United States

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor