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

Recruiting now · Phase 2

Conditions studied: Autologous Stem Cell Transplant, Classic Hodgkin Lymphoma

In brief

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.

Key facts

Study ID

NCT06377540

Run by

Masonic Cancer Center, University of Minnesota

People needed

28

Starts

2024-12-04

Expected to finish

2027-09-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Masonic Cancer Center — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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