RecruitingPhase 2NCT03618550

Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma

Phase II Study of Second-line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

257 participants

Start Date

Aug 1, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to test any good and bad effects of the study drug, pembrolizumab, in combination with GVD in the treatment of Hodgkin lymphoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding an immunotherapy drug (pembrolizumab) to a chemotherapy combination (gemcitabine, vinorelbine, and liposomal doxorubicin, known as GVD) can help patients with relapsed or treatment-resistant Hodgkin lymphoma (a type of blood cancer) who are being considered for a stem cell transplant. **You may be eligible if...** - You have been diagnosed with classical Hodgkin lymphoma, confirmed by biopsy - Your disease has come back or did not respond to one prior chemotherapy regimen - You are eligible to receive a high-dose stem cell transplant - You achieved a complete response (all cancer gone on scans) after 2 cycles of pembrolizumab + GVD - You are 18 years or older and in good general health (ECOG 0 or 1) **You may NOT be eligible if...** - You have had more than one prior line of treatment - You are not eligible for stem cell transplant - You are pregnant or have active autoimmune disease 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

Age 10-17: 2mg/kg (cap at 200mg), Age ≥ 18: 200 mg (flat) ,Day 1 of each 3 week cycle IV infusion 2-4 cycles (pre-ASCT)

DRUGgemcitabine

1000mg/m\^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles

DRUGvinorelbine

20mg/m\^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles

DRUGliposomal doxorubicin

15mg/m\^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles

PROCEDUREStem cell mobilization and collection

Stem cell mobilization and collection will be performed as per standard MSKCC guidelines after 2-4 cycles of pembrolizumab-GVD.


Locations(10)

City of Hope Cancer Center (Data Collection Only)

Duarte, California, United States

Stanford University Medical Center

Stanford, California, United States

University of Miami

Miami, Florida, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT03618550


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