Pembrolizumab Followed by Chemotherapy for Treating Classical Hodgkin Lymphoma

Sponsor: Northwestern University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06164275

Provider View

This study is testing how well the drug pembrolizumab, followed by chemotherapy, works in treating patients with classical Hodgkin lymphoma. Pembrolizumab helps the immune system fight cancer, while chemotherapy drugs work to stop cancer cells from growing and spreading.

Patient Parameters

Program Overview

This phase II clinical trial is exploring the effectiveness of using pembrolizumab, a drug that boosts the immune system, followed by chemotherapy drugs doxorubicin, vinblastine, and dacarbazine, to treat classical Hodgkin lymphoma. The goal is to see if this combination can effectively treat the cancer by stopping its growth and spread.

Description

The main goal of this study is to see how many patients achieve a complete response, meaning no signs of cancer, after receiving pembrolizumab alone as the first treatment. This is for patients with early unfavorable or advanced classical Hodgkin lymphoma, assessed by specific imaging tests.

Secondary goals include:

  • Evaluating the effectiveness of fewer cycles of chemotherapy (2-4 cycles) after pembrolizumab treatment.
  • Checking the safety and side effects of using pembrolizumab followed by chemotherapy.
  • Measuring how long patients live without the cancer getting worse and their overall survival.
  • Assessing the complete response rate after pembrolizumab treatment using imaging tests.

Study Outline:

  • Induction Phase: Patients receive pembrolizumab through an IV every 21 days for 3 cycles, unless the cancer progresses or side effects are too severe. If the cancer responds, patients continue with 3 more cycles of pembrolizumab before moving to the next phase. If not, they proceed to the next phase directly.

  • Consolidation Phase: Patients receive chemotherapy drugs doxorubicin, vinblastine, and dacarbazine through an IV on days 1 and 15 of each cycle. This phase lasts 2 to 6 cycles, depending on the response and type of disease. Patients undergo various scans and tests throughout the study.

After completing the treatment, patients are monitored at 30 days, every 3 months for the first year, and every 6 months for the next four years.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of classical Hodgkin lymphoma at certain stages or with specific risk factors.
  • Must have measurable disease that shows up on specific imaging tests.
  • Must not have received any prior treatment for Hodgkin lymphoma.
  • Must be 18 years or older.
  • Must be in good general health with a performance status of 0 or 1.
  • Must have adequate blood cell counts and organ function as determined by specific tests.
  • Women of childbearing potential must agree to use effective contraception during the study and for 120 days after treatment.
  • Men must agree to use effective contraception and not donate sperm during the study and for 120 days after treatment.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot have a different type of Hodgkin lymphoma.
  • Cannot have received prior treatment for Hodgkin lymphoma.
  • Cannot be participating in another clinical trial with an investigational agent.
  • Cannot have active cancer spread to the brain or spinal fluid.
  • Cannot have allergies to pembrolizumab or similar drugs.
  • Cannot have had an organ transplant.
  • Cannot be pregnant or breastfeeding.
  • Cannot have a history of certain infections or autoimmune diseases.
  • Cannot have received certain vaccines recently.
  • Cannot have other serious health conditions that might interfere with the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.