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

NCT06377540 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-07-01

No results posted yet for this study

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.

Conditions

  • Autologous Stem Cell Transplant
  • Classic Hodgkin Lymphoma

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.

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-04
Primary Completion
2026-09-01
Completion
2027-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06377540 on ClinicalTrials.gov