RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Masonic Cancer Center, University of Minnesota • ClinicalTrials.gov ID: NCT06377540

Registry updated: 2026-09-29

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Description

This is a Phase 2 single arm study to evaluate efficacy and safety of Pembrolizumab before with BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab Q3week starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.

Interventions

Pembrolizumab (Drug)
Patients will receive 200 mg Pembrolizumab on Day -28 and Day -6 by IV infusion. Pembrolizumab 200 mg IV will resume at day 30+ after ASCT every 3 weeks for 1 year.
Autologous stem cell transplant (Procedure)
On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
Carmustine (Drug)
Patient will receive a single dose of BCNU on day -6, dose of 300 mg/m2 by IV infusion.
Etoposide (Drug)
Etoposide will be given at dose 100 mg/m2 BID intravenously on days -5, - 4, -3, and -2.
Cytarabine (Drug)
Cytarabine will be given at dose 100 mg/m2 BID intravenously on days -5, -4, - 3, and -2.
Melphalan (Drug)
Melphalan will be given at dose of 140 mg/m2 intravenously on day -1 in a single 20 minute infusion; dose will be based on actual body weight but capped at 3.6 mg/kg as part of BEAM conditioning.

Eligibility 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

Conditions

Autologous Stem Cell Transplant Classic Hodgkin Lymphoma

Locations

Masonic Cancer Center — Minneapolis, Minnesota, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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