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Phase 2 Pembrolizumab with BEAM for Relapsed Hodgkin Lymphoma

This study is testing a treatment plan for people with classic Hodgkin Lymphoma that has returned (relapsed). It combines a drug called Pembrolizumab with a chemotherapy regimen called BEAM (Carmustine, Etoposide, Cytarabine) and an autologous stem cell transplant (ASCT), where your own healthy stem cells are given back to you. You would receive Pembrolizumab before the transplant and then continue it for one year afterward. The main goal is to see how long people live without their cancer getting worse (progression-free survival) for one year after the transplant. To join, you must be eligible for an ASCT with BEAM, have good overall health, and adequate organ function. The study plans to enroll 28 participants.

Study design
This is a Phase 2 study, meaning it's an early-stage study to see if a new treatment is safe and effective. It is a single-arm study, so all 28 participants will receive the same treatment.
What's involved
You would receive Pembrolizumab infusions before and after your stem cell transplant, along with chemotherapy. The stem cell transplant itself involves an infusion of your own cells. This treatment continues for one year after the transplant.
Compensation
Not stated in the trial record.
Follow-up
The main outcome is measured at one year after the autologous stem cell transplant.

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NCT06377540

MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Masonic Cancer Center, University of Minnesota
~28 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:PembrolizumabAutologous stem cell transplantCarmustineEtoposideCytarabineMelphalan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS)
Measured over Baseline to 1 year post-ASCT

Conditions

Autologous Stem Cell Transplant
Classic Hodgkin Lymphoma

Explore related trials

Classic Hodgkin Lymphoma

Where it's being run

1 sites across 1 states
Minnesota1

Who to contact

Sanjal Desai
[email protected]
612-625-5469
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Progression free survival (PFS)Baseline to 1 year post-ASCT

    Number of participants with progression free survival at 1 year post transplant. Time from date of study enrollment to date of first documented progression, or death. Patients who do not progress or die at the time of analysis will be censored at their last known date alive.