Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL
Plain-language summary
This trial is testing Vinblastine (Velban) for patients with anaplastic large cell lymphoma (ALCL) who have been newly diagnosed and have not yet received treatment as well as those whose disease has come back or stopped responding to prior treatment. This is a Phase 2 trial, which means researchers are studying how well the treatment works and monitoring for side effects. Patients are randomly assigned to different treatment groups. This trial is available at 1 location in the United States. The trial is currently recruiting patients.
Who can join (key eligibility)
- Age 1 Year to 39 Years years
- Newly diagnosed, not yet treated
- Must be well enough for treatment (adequate performance status)
Final eligibility is determined by the trial team. This list is a starting point only.
What's being tested
Vinblastine (Velban) (DRUG): Low risk cohort patients will receive 2 cycles of Induction therapy with single-drug vinBLAStine (VBL), then undergo disease assessment. If complete remission (CR) and MRD -, LR patients will continue single-drug VBL for a total of 24 months (if absent disease progression or unacceptable toxicity). | Brentuximab vedotin (Adcetris) (DRUG): HR cohort patients with no previous exposure to BV will receive 2 cycles of Induction therapy with BV and NIVO \[BV + NIVO\] one every 21 days, then undergo disease assessment. Patients in CR will proceed with consolidation with RTC allogeneic SCT (SCT)\*. If patient has any response other than CR and MRD-, they will receive 2 cycles of BV, VBL, and NIVO \[BV + VBL + NIVO\] once every 21 days | Nivolumab (Opdivo) (DRUG): High risk cohort patients with previous exposure to Brentuximab vedotin (BV) will receive 2 cycles of Induction therapy with VBL and NIVO \[VBL + NIVO\] on day 1 and 15, then undergo disease assessment. If response is not CR, or patient has PR/SD/PD, patient will receive \[BV+VBL+NIVO\] and subsequent therapy as defined for the HR2 cohort.
Vinblastine (Velban), Brentuximab vedotin (Adcetris), Nivolumab (Opdivo)
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details