Combination of Pembrolizumab and BEAM for treating relapsed Hodgkin Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Masonic Cancer Center
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Sanjal Desai
• Email: desai171@umn.edu
• Phone: 612-625-5469

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.