Actively Recruiting
MT2022-60: Phase II Study of Pembrolizumab with BEAM Conditioning Before Autologous Stem Cell Transplant Followed by Pembrolizumab Maintenance in Relapsed or Refractory Classic Hodgkin Lymphoma
Led by Masonic Cancer Center, University of Minnesota · Updated on 2025-07-01
28
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of Pembrolizumab combined with BEAM conditioning and autologous stem cell transplant (ASCT) in adults with relapsed or refractory classic Hodgkin lymphoma. It is a Phase 2 single-arm study focused on patients eligible for this transplant treatment. The study is sponsored by the Masonic Cancer Center at the University of Minnesota and investigates progression-free survival as a key outcome.
CONDITIONS
Brief Title
MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible for autologous stem cell transplant with BEAM conditioning regimen
- Karnofsky Performance Status (KPS) greater than 70 or ECOG performance status 0 or 1
- Adequate organ function and blood counts within 14 days before study registration
- Participants positive for hepatitis B surface antigen must have received anti-viral therapy for at least 4 weeks and have undetectable viral load before randomization
- Participants with a history of hepatitis C virus infection must have undetectable viral load at screening
- HIV-infected participants must have well-controlled HIV on antiretroviral therapy
You will not qualify if you...
- History of moderate or severe autoimmune reaction to PD-1 inhibitors requiring permanent discontinuation or systemic immunosuppressants
- Radiotherapy within 2 weeks before starting study treatment or radiation-related toxicities requiring corticosteroids
- Live vaccine or live-attenuated vaccine within 30 days before first dose of study treatment (killed vaccines allowed)
- Chemotherapy within 3 weeks before first dose of study treatment
- Known active central nervous system disease
- History of or active autoimmune disease requiring systemic steroids or autoimmune agents (exceptions apply)
- Prior allogeneic tissue or solid organ transplant
- Pregnant or breastfeeding females; females of childbearing potential must have a negative pregnancy test within 14 days before registration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 13 months
Participants receive Pembrolizumab before BEAM conditioning and autologous stem cell transplant, followed by Pembrolizumab maintenance for 1 year after transplant.
1 infusion at Day -28 and Day -6 before transplant; stem cell transplant on Day 0; Pembrolizumab infusions every 3 weeks starting Day 30+ for 1 year
Duration - Up to 5 years post-transplant
Participants are monitored for progression-free survival and overall survival up to 5 years post-transplant.
Visits according to follow-up schedule for survival monitoring
Trial Site Locations
Total: 1 location
1
Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
S
Sanjal Desai
R
Roberta Nicklow
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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