RecruitingPhase 2NCT06377540

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

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


Sponsor

Masonic Cancer Center, University of Minnesota

Enrollment

28 participants

Start Date

Dec 4, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding pembrolizumab (an immunotherapy drug) to the standard BEAM chemotherapy regimen before an autologous stem cell transplant (a procedure using your own stem cells) improves outcomes for people with relapsed Hodgkin lymphoma. **You may be eligible if...** - You are eligible for an autologous stem cell transplant with BEAM conditioning - Your general health and organ function are adequate (KPS greater than 70 or ECOG 1 or better) - If you have hepatitis B or C, it must be well controlled with treatment - If you have HIV, it must be well controlled on antiretroviral therapy **You may NOT be eligible if...** - You have had a grade 2 or higher immune-related side effect from a PD-1 inhibitor (like pembrolizumab or nivolumab) that required stopping treatment or using immune-suppressing drugs - You have active autoimmune disease requiring systemic treatment - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Masonic Cancer Center

Minneapolis, Minnesota, United States

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NCT06377540


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