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
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * Pati…
Interventions
- DrugPembrolizumab
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.
- ProcedureAutologous stem cell transplant
On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
- DrugCarmustine
Patient will receive a single dose of BCNU on day -6, dose of 300 mg/m2 by IV infusion.
- DrugEtoposide
Etoposide will be given at dose 100 mg/m2 BID intravenously on days -5, - 4, -3, and -2.
- DrugCytarabine
Cytarabine will be given at dose 100 mg/m2 BID intravenously on days -5, -4, - 3, and -2.
- DrugMelphalan
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.
Location
- Masonic Cancer CenterMinneapolis, Minnesota