A Phase II Study of Pembrolizumab Immunotherapy plus Chemotherapy followed by Autologous Stem Cell Transplantation for Recurrent or Persistent Hodgkin Lymphoma

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Full Title

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

Purpose

The purpose of this study is to assess the safety and effectiveness of combining pembrolizumab immunotherapy with standard chemotherapy drugs and autologous stem cell transplantation (ASCT) in patients with Hodgkin lymphoma that has come back or continued to grow despite one regimen of prior therapy. Pembrolizumab blocks PD-1, a protein cancer cells use to evade detection by the immune system, thereby enabling the immune system to find and kill cancer cells.

In this study, patients will receive pembrolizumab with three chemotherapy drugs: gemcitabine, vinorelbine, and liposomal doxorubicin. Depending on how well they respond to this treatment, they may also have ASCT. During ASCT, a patient’s own blood-forming stem cells are collected, and he or she is then treated with high doses of chemotherapy. Afterward, the collected stem cells are re-infused back into the patient to re-establish the blood-forming system.

The drugs used in this study are given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have recurrent or persistent Hodgkin lymphoma after no more than one prior regimen of therapy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 10 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Alison Moskowitz at 212-639-4839.

Protocol

18-160

Phase

Phase II (phase 2)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT03618550