Venetoclax, Dexamethasone, Bortezomib, and Daratumumab For The Treatment Of Adolescent And Young … (NCT07513129) | Clinical Trial Compass
Not Yet RecruitingPhase 1
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
United States18 participantsStarted 2026-09-01
Plain-language 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
Who can participate
Age range12 Years – 30 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 stu…
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year