MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT06377540
Phase
PHASE2
Status
Recruiting
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Conditions

  • Autologous Stem Cell Transplant
  • Classic Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    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 — PROCEDURE
    On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
  • Carmustine — DRUG
    Patient will receive a single dose of BCNU on day -6, dose of 300 mg/m2 by IV infusion.
  • Etoposide — DRUG
    Etoposide will be given at dose 100 mg/m2 BID intravenously on days -5, - 4, -3, and -2.
  • Cytarabine — DRUG
    Cytarabine will be given at dose 100 mg/m2 BID intravenously on days -5, -4, - 3, and -2.
  • Melphalan — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 4, 2024
Status verified
Jun 2025
Primary completion
Sep 1, 2026
Completion
Sep 1, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: Baseline to 1 year post-ASCT ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Masonic Cancer CenterMinneapolisMinnesota55455
Sanjal Desai, MD

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By research site
Masonic Cancer Center· Minneapolis, MN

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