Combination of Pembrolizumab and BEAM for treating relapsed Hodgkin Lymphoma
MT2022-60: A Phase II Study of Pembrolizumab+ BEAM Conditioning Regimen Before Autologous Stem Cell Transplant (ASCT) Followed by Pembrolizumab Maintenance in Patients of Relapsed or Refractory Classic Hodgkin Lymphoma
This study is testing if giving Pembrolizumab before and after a stem cell transplant can help people with relapsed Hodgkin Lymphoma feel better and have better outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Masonic Cancer Center, University of Minnesota Academic / other |
| Drugs / interventions | chemotherapy, radiation, prednisone, Pembrolizumab |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06377540 on ClinicalTrials.gov |
What this trial studies
This Phase 2 study evaluates the efficacy and safety of Pembrolizumab administered before and after an autologous stem cell transplant (ASCT) using the BEAM conditioning regimen in patients with relapsed classic Hodgkin Lymphoma. Participants will receive Pembrolizumab starting 28 days prior to the transplant and continue for one year post-transplant. The study aims to assess how well this combination therapy works in improving patient outcomes and safety profiles.
Who should consider this trial
Good fit: Ideal candidates are patients eligible for ASCT with a BEAM conditioning regimen and adequate organ function.
Not a fit: Patients with a history of severe autoimmune reactions to PD-1 inhibitors or recent radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with relapsed Hodgkin Lymphoma.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in hematologic malignancies, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eligible for autologous stem cell transplant (ASCT) with BEAM conditioning regimen * KPS greater than 70 or ECOG ≤ 1 * Adequate organ function and blood counts within 14 days of study registration * Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization. * Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening. * HIV-infected participants must have well-controlled HIV on ART Exclusion Criteria: * Patients with prior history of any grade 2 or higher autoimmune reaction to PD-1 inhibitors, necessitating permanent discontinuation of the PD-1 inhibitor or necessitating systemic immunosuppressants. * Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids. * Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. * Has received any chemotherapy within 3 weeks prior to the first dose of study intervention * Has known active CNS disease. * History of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents. Exceptions: Participants with vitiligo, resolved childhood asthma or atopy, hypothyroidism, or Sjogren's syndrome, as well as participants requiring only intranasal steroids, intermittent use of bronchodilators, local steroid injections, or physiologic replacement doses of prednisone (≤ 10 mg/d) may enroll. * Has had an allogenic tissue/solid organ transplant. * Pregnant or breastfeeding as agents used in this study are Pregnancy Category D (positive evidence of risk). Females of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days of study registration
Where this trial is running
Minneapolis, Minnesota
- Masonic Cancer Center — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Sanjal Desai
- Email: desai171@umn.edu
- Phone: 612-625-5469
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.