Actively Recruiting
MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma
Led by Masonic Cancer Center, University of Minnesota · Updated on 2025-07-01
28
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 (ASCT) with BEAM conditioning regimen
- Karnofsky Performance Status (KPS) greater than 70 or ECOG score 0 to 1
- Adequate organ function and blood counts within 14 days before study registration
- If positive for hepatitis B surface antigen (HBsAg), must have received antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
- If history of hepatitis C virus (HCV) infection, must have undetectable HCV viral load at screening
- HIV-infected participants must have well-controlled HIV on antiretroviral therapy (ART)
You will not qualify if you...
- Prior grade 2 or higher autoimmune reaction to PD-1 inhibitors requiring permanent discontinuation or systemic immunosuppressants
- Received radiotherapy within 2 weeks before study start or has radiation-related toxicities requiring corticosteroids
- Received live or live-attenuated vaccine within 30 days before first study dose (killed vaccines allowed)
- Received any chemotherapy within 3 weeks before first study dose
- Known active central nervous system (CNS) disease
- History of or active autoimmune disease requiring systemic steroids or autoimmune agents, except vitiligo, resolved childhood asthma or atopy, hypothyroidism, Sjogren's syndrome, or limited steroid use as specified
- History of allogenic tissue or solid organ transplant
- Pregnant or breastfeeding; females of childbearing potential must have a negative pregnancy test within 14 days before study registration
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
S
Sanjal Desai
CONTACT
R
Roberta Nicklow
CONTACT
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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