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RECRUITING
NCT06377540
PHASE2

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

Sponsor: Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

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

DRUG

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.

PROCEDURE

Autologous stem cell transplant

On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.

DRUG

Carmustine

Patient will receive a single dose of BCNU on day -6, dose of 300 mg/m2 by IV infusion.

DRUG

Etoposide

Etoposide will be given at dose 100 mg/m2 BID intravenously on days -5, - 4, -3, and -2.

DRUG

Cytarabine

Cytarabine will be given at dose 100 mg/m2 BID intravenously on days -5, -4, - 3, and -2.

DRUG

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