Study on Pembrolizumab and Targeted Radiation Therapy for Early Stage Relapsed or Hard-to-Treat Hodgkin Lymphoma

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03179917

This clinical trial is testing a new treatment approach using pembrolizumab followed by targeted radiation therapy to see if it can effectively treat early stage Hodgkin lymphoma that has either returned after treatment or is not responding to initial therapy.

Patient Parameters

Program Overview

The purpose of this study is to find out if combining the drug pembrolizumab with a specific type of radiation therapy, called involved site radiotherapy, can help treat patients with early stage Hodgkin lymphoma that has come back or is not responding to initial treatment. The goal is to see if this approach can cure a significant number of patients while avoiding the side effects of larger radiation areas or additional chemotherapy and stem cell transplants.

Eligibility Criteria

Inclusion Criteria

  • Patients with early stage Hodgkin lymphoma (stage I-II) who were treated with chemotherapy alone and have relapsed with early stage disease.
  • Patients with early stage Hodgkin lymphoma (stage I-II) who were treated with chemotherapy alone and have primary refractory disease (disease still present after initial treatment) without severe symptoms and with each affected area smaller than 10 cm.
  • Patients with early stage Hodgkin lymphoma (stage I-II) who were treated with both chemotherapy and radiation and have relapsed with early stage disease outside the previous radiation area.
  • Must have a confirmed diagnosis of classical Hodgkin Lymphoma after imaging shows relapsed or refractory disease.
  • Age 12 or older.
  • Good overall health with a performance status score of 0-1 or a Lansky score of 50 or higher for ages 12-15.
  • Adequate organ function based on specific blood tests done within 14 days before starting treatment.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use two methods of birth control or be surgically sterile during the study and for 120 days after the last dose.
  • Men must agree to use effective contraception during the study and for 120 days after the last dose.

Exclusion Criteria

  • Patients with advanced stage (III or IV) Hodgkin lymphoma at diagnosis or relapse.
  • Patients with large tumors (greater than 10 cm) at diagnosis or relapse.
  • Patients with active severe symptoms related to Hodgkin lymphoma.
  • Patients who have received more than one line of therapy for Hodgkin lymphoma.
  • Patients with relapsed or refractory disease within a previous radiation area.
  • Patients who have had chemotherapy, targeted therapy, or radiation within 2 weeks before starting the study and have not recovered from side effects.
  • Patients with immune system suppression or on systemic steroid therapy within 7 days before starting the study.
  • Patients with another progressing cancer requiring treatment, except for certain skin cancers or cervical cancer treated with curative intent.
  • Patients with active autoimmune disease requiring treatment in the past 2 years.
  • Patients with a history of lung inflammation requiring steroids or active lung disease.
  • Patients with active infections requiring intravenous treatment.
  • Patients with known HIV, Hepatitis B, or Hepatitis C infections.
  • Patients who have received a live vaccine within 30 days before starting the study.
  • Patients with any medical condition or lab result that makes them unsuitable for the study.
  • Patients who have had a monoclonal antibody treatment within 4 weeks before starting the study and have not recovered from side effects.
  • Patients who have had treatment with antibodies targeting PD-1, PD-L1, PD-L2, or CTLA-4.
  • Patients with heart or lung function below specific levels before treatment.
  • Patients who are pregnant, breastfeeding, or planning to conceive or father children during the study and for 120 days after the last dose.

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