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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Minnesota
Masonic Cancer Center
RECRUITING
Minneapolis
Contact Information
Primary
Sanjal Desai
desai171@umn.edu
612-625-5469
Backup
Roberta Nicklow
nickl004@umn.edu
Time Frame
Start Date: 2024-12-04
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 28
Treatments
Experimental: Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year.
Patients will receive Pembrolizumab before BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.
Sponsors
Leads: Masonic Cancer Center, University of Minnesota

This content was sourced from clinicaltrials.gov

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