Not Yet RecruitingPhase 2/3

Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem Cell Transplant Alone for High-risk Patients With Relapsed or Refractory Hodgkin Lymphoma

374 participantsStarted 2026-12-04

Plain-language summary

This phase II trial compares the impact of brentuximab vedotin and nivolumab after radiation to standard of care high dose chemotherapy (HDT)-autologous stem cell transplant (ASCT) in standard-risk patients with classic Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). In addition, the phase III trial will compare the effect of pembrolizumab after HDT-ASCT to standard of care HDT-ASCT alone in high-risk patients with relapsed or refractory classic Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. Immunotherapy with monoclonal antibodies, such as nivolumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. An ASCT is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Giving HDT before an ASCT helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Radiation therapy (RT) uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving brentuximab vedotin and nivolumab after radiation may be safe, tolerable and more effective than standard of care HDT-ASCT in treating patients with standard risk relapsed or refractory classic Hodgkin lymphoma. In addition, giving pembrolizumab after standard of care HDT-ASCT may be safe and tolerable and more effective than HDT-ASCT alone in treating high-risk patients with relapsed or refractory classic Hodgkin lymphoma.

Who can participate

Age range5 Years – 75 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: * STEP 0 REGISTRATION: Patient must have biopsy confirmed relapsed classical Hodgkin lymphoma * STEP 0 REGISTRATION: Patient must be 5-75 years of age * STEP 0 REGISTRATION: Patient must have relapsed/refractory classical Hodgkin lymphoma (R/R cHL) after first line of chemotherapy * STEP 0 REGISTRATION: Patients \> 17 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and patients ≤ 17 years of age must have a Lansky performance status 50-100 * STEP 0 REGISTRATION: Patient must have had a PET CT or magnetic resonance imaging (MRI) (PET1) confirming relapse. The PET1 must have been completed prior to starting any salvage therapy and must be obtained within 56 days prior to Step 0 registration * NOTE: If patient received one cycle of salvage prior to study enrollment, PET1 confirming relapse must have been completed prior to the initiation of any salvage therapy * STEP 0 REGISTRATION: Patient must be considered standard- or high-risk at the time of initial relapse. If a patient meets one the following criteria below, they are considered high risk: * Primary refractory disease to frontline therapy * Relapse in \< 3 months after completion of frontline non-checkpoint inhibitor containing therapy * Relapse in \< 6 months after completion of frontline checkpoint inhibitor containing therapy * \> 4 disease sites at relapse (as defined by the German Hodgkin Study Groups \[GHSG\] Criteria) * Prior radiation tha…

What they're measuring

Progression-free survival (PFS) (Standard risk cohort)

Timeframe: From randomization to progression or death without documented progression, assessed up to 15 years

PFS (High-risk cohort)

Timeframe: From randomization to progression or death without documented progression, assessed up to 15 years

Trial details

NCT IDNCT07572123

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2029-03-31