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MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma
Sponsor: Masonic Cancer Center, University of Minnesota
Summary
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.
Official title: MT2022-60: A Phase II Study of Pembrolizumab+ BEAM Conditioning Regimen Before Autologous Stem Cell Transplant (ASCT) Followed by Pembrolizumab Maintenance in Patients of Relapsed or Refractory Classic Hodgkin Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2024-12-04
Completion Date
2027-09-01
Last Updated
2025-07-01
Healthy Volunteers
No
Interventions
Pembrolizumab
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
On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
Carmustine
Patient will receive a single dose of BCNU on day -6, dose of 300 mg/m2 by IV infusion.
Etoposide
Etoposide will be given at dose 100 mg/m2 BID intravenously on days -5, - 4, -3, and -2.
Cytarabine
Cytarabine will be given at dose 100 mg/m2 BID intravenously on days -5, -4, - 3, and -2.
Melphalan
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.
Locations (1)
Masonic Cancer Center
Minneapolis, Minnesota, United States