Study on Nivolumab and Brentuximab Vedotin After Stem Cell Transplant for High-Risk Hodgkin Lymphoma
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT03057795
This clinical trial is testing how well the combination of nivolumab and brentuximab vedotin works in patients with high-risk Hodgkin lymphoma that has returned or not responded to treatment, after they have undergone a stem cell transplant.
Patient Parameters
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Program Overview
The purpose of this study is to see if the drugs nivolumab and brentuximab vedotin can help control Hodgkin lymphoma that is high-risk, meaning it has come back or not responded to previous treatments, after a stem cell transplant. These drugs are types of immunotherapy that may help the immune system attack cancer cells and stop them from growing and spreading.
Description
The main goal of this study is to find out how effective the combination of nivolumab and brentuximab vedotin is in keeping Hodgkin lymphoma from progressing for 18 months after a stem cell transplant. Researchers will also look at overall survival rates, how often the cancer comes back, and any deaths not related to cancer. They will assess how well patients respond to the treatment and how safe and tolerable the drugs are.
The study will also explore how the treatment affects the immune system after the transplant and look at specific genetic factors that might influence outcomes. Patients will start receiving the treatment 30 to 60 days after their stem cell transplant. They will get brentuximab vedotin and nivolumab through an IV every 21 days for up to 8 cycles, as long as the cancer does not progress and there are no severe side effects.
After finishing the treatment, patients will have follow-up visits at 30 and 100 days, then at 3, 6, 12, and 18 months, and every six months after that.
Eligibility Criteria
Inclusion Criteria
- Must provide informed consent and agree to use pre-transplant tumor samples if available.
- Must have a performance status score of 0 to 2, meaning they are fully active or able to do light work.
- Must have a confirmed diagnosis of high-risk classical Hodgkin lymphoma.
- Must have had a stem cell transplant or be planning to have one.
- Must start treatment 30 to 60 days after the stem cell transplant.
- Must have recovered from transplant side effects and be able to eat and drink normally.
- Must have stable disease after salvage treatment before the transplant.
- Must have certain blood counts and organ function within specified limits.
- Women of childbearing potential must have a negative pregnancy test and use effective contraception during the study and for 7 months after the last dose of nivolumab.
- Men must use effective contraception during the study and for 7 months after the last dose of nivolumab.
Exclusion Criteria
- Cannot have received any anti-lymphoma or investigational therapy after the stem cell transplant, except for certain radiation therapy.
- Cannot have had a previous allogeneic transplant.
- Cannot have received a high dose of carmustine in previous treatments.
- Cannot have had a live vaccine within 30 days before starting the study treatment.
- Cannot be refractory to previous brentuximab vedotin or anti-PD-1/PD-L1 treatments.
- Cannot have severe allergies to the study drugs.
- Cannot have another primary cancer that has not been in remission for at least 3 years, with some exceptions.
- Cannot have active central nervous system involvement by lymphoma.
- Cannot have a history of certain severe lung diseases or autoimmune diseases, with some exceptions.
- Cannot have active infections like hepatitis B, C, or HIV.
- Cannot be pregnant or breastfeeding.
- Cannot have had recent severe heart problems.
- Cannot have any condition that might interfere with the study or the patient's ability to participate.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Medical Center | 91010 | Duarte | California |
| Mayo Clinic in Rochester | 55905 | Rochester | Minnesota |
| Hackensack University Medical Center | 07601 | Hackensack | New Jersey |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| M D Anderson Cancer Center | 77030 | Houston | Texas |
| Fred Hutchinson Cancer Research Center | 98109 | Seattle | Washington |
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