Study on Nivolumab and Lenalidomide for Treating Relapsed or Resistant Non-Hodgkin or Hodgkin Lymphoma

Sponsor: David Bond, MD

Sponsor score: 0

ClinicalTrials ID:NCT03015896

This clinical trial is testing a combination of two drugs, nivolumab and lenalidomide, to see if they can help treat patients with Non-Hodgkin or Hodgkin lymphoma that has returned or is not responding to treatment. The study aims to find the best dose and understand the side effects of this combination.

Patient Parameters

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Program Overview

The purpose of this study is to determine if combining nivolumab, a monoclonal antibody, with lenalidomide, a chemotherapy drug, can effectively treat patients with Non-Hodgkin or Hodgkin lymphoma that has come back or is not responding to other treatments. Nivolumab may help stop tumor cells from growing and spreading, while lenalidomide works by killing cancer cells or stopping them from dividing. The study will explore the safety, best dosage, and effectiveness of this combination treatment.

Description

This study is divided into two phases. In Phase I, researchers will determine the safety and best dose of lenalidomide when combined with nivolumab for patients with relapsed or resistant Non-Hodgkin lymphoma (NHL). In Phase IB, the focus is on Hodgkin's disease. Phase II will evaluate how well this combination works in treating follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL).

The study will also look at how long patients respond to the treatment, how long they live without the disease getting worse, and their overall survival rates. Researchers will explore how certain biological markers relate to the treatment's effectiveness and monitor the effects on different immune cells.

Participants will take lenalidomide by mouth on specific days and receive nivolumab through an IV on other days. The treatment cycles repeat every 28 days unless the disease progresses or side effects become unacceptable. After completing the treatment, patients will have follow-up visits every few months for up to five years.

Eligibility Criteria

Inclusion Criteria

Have a confirmed diagnosis of specific types of Non-Hodgkin or Hodgkin lymphoma that has returned or is resistant to treatment.
Have received at least one prior therapy, including possible stem cell transplant.
Be willing to provide written consent and comply with study procedures.
Have measurable disease and be in good overall health with a performance status score of 0-2.
Meet specific blood count and organ function requirements.
Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 120 days after.
Men must agree to use contraception and not donate sperm during the study and for 120 days after.
Be willing to receive preventive treatment for blood clots.

Exclusion Criteria

Currently participating in another study or have used an investigational drug or device recently.
Have a diagnosis of immunodeficiency or are on immunosuppressive therapy.
Have a history of active tuberculosis or severe allergies to study drugs.
Have had recent chemotherapy, radiation, or surgery without adequate recovery.
Have another progressing cancer or active central nervous system lymphoma.
Have an active autoimmune disease requiring treatment in the past two years.
Have an active infection needing IV treatment.
Have significant heart disease or are pregnant or breastfeeding.
Have progressed on previous treatments with similar drugs.
Have a history of HIV, active hepatitis B or C, or blood clotting disorders.

Locations

FACILITY	ZIP	CITY	STATE
Emory University	30322	Atlanta	Georgia
Ohio State University Comprehensive Cancer Center	43210	Columbus	Ohio

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