Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL
Plain-language summary
This Phase 2 trial is comparing different first-line treatment approaches for people newly diagnosed with ALK-positive ALCL. Patients are randomly assigned to different treatment groups to see which approach works best. It is available at 1 US location.
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.
- Drugs / treatments
- Vinblastine (Velban), Brentuximab vedotin (Adcetris), Nivolumab (Opdivo)
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details