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

Hodgkin Lymphoma Relapsed or Refractory Hodgkin Lymphoma

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.

RADIATIONInvolved-site radiation therapy

Involved-site radiation therapy (ISRT) Patients with limited sites of disease prior to initiation of pembro-GVD are eligible to receive ISRT prior to ASCT or with pembrolizumab maintenance. n. ISRT to nodal based disease should be delivered in line with the guidelines provided by the International Lymphoma Radiation Oncology Group.