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Anti-tumor antibiotic

Pembrolizumab + Chemotherapy for Hodgkin's Lymphoma

Phase 2
Waitlist Available
Led By Jane Winter, M.D.
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have a histologically confirmed diagnosis of classical Hodgkin lymphoma by the 4th edition of the World Health Organization (WHO) Classification of Tumors of Hematopoietic and Lymphoid Tissues
Patients must have adequate organ and bone marrow function within 14 days prior to registration
Must not have
Patients with a known history of active TB
Patients with known additional malignancy that is progressing or requires active treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

This trial studies a combination of chemotherapy & a new drug to treat newly diagnosed Hodgkins Lymphoma. The goal is to see if the new drug improves treatment outcomes.

Who is the study for?
This trial is for patients with newly diagnosed classical Hodgkin lymphoma who haven't been treated yet, except possibly a short course of steroids. They should be in good physical condition (ECOG 0-1), have measurable disease by Lugano criteria, and can have any stage or score. Key blood counts and liver function tests must meet specific levels.
What is being tested?
The study is testing pembrolizumab, a drug approved for other cancers but not yet for Hodgkin's lymphoma, combined with AVD chemotherapy (adriamycin, vinblastine, dacarbazine). The effectiveness of this combination will be evaluated using PET scans to monitor response to treatment.
What are the potential side effects?
Pembrolizumab may cause immune system reactions affecting organs, fatigue, skin issues and infusion-related side effects. Chemotherapy can lead to nausea, hair loss, increased infection risk and potential damage to the heart or nerves.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diagnosis is classical Hodgkin lymphoma, confirmed by a specific WHO classification.
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My organs and bone marrow are functioning well.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active case of tuberculosis.
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I have another cancer that is getting worse or needs treatment.
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I have an immune system disorder or have taken steroids in the last week.
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I do not have uncontrolled heart conditions like heart failure or irregular heartbeat.
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I have previously been treated with drugs targeting PD-1, PD-L1, or PD-L2.
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I have active hepatitis B or C.
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I have a history of or currently have non-infectious lung inflammation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete Response (CR) With Pembrolizumab Treatment Alone
Secondary study objectives
FDG Uptake
Incidence of Adverse Events
OS for Elderly Patients
+3 more

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (FDG-PET/CT, pembrolizumab, chemotherapy)Experimental Treatment8 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludeoxyglucose F-18
2018
Completed Phase 4
~610
Vinblastine
FDA approved
Pembrolizumab
FDA approved
Positron Emission Tomography
2011
Completed Phase 2
~2200
Computed Tomography
2017
Completed Phase 2
~2790
Imidazole
Not yet FDA approved
Doxorubicin
FDA approved

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
4,032 Previous Clinical Trials
5,189,771 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,652 Previous Clinical Trials
961,485 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,057 Total Patients Enrolled
Jane Winter, M.D.Principal InvestigatorNorthwestern University

Media Library

Doxorubicin Hydrochloride (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03226249 — Phase 2
Hodgkin's Lymphoma Research Study Groups: Treatment (FDG-PET/CT, pembrolizumab, chemotherapy)
Hodgkin's Lymphoma Clinical Trial 2023: Doxorubicin Hydrochloride Highlights & Side Effects. Trial Name: NCT03226249 — Phase 2
Doxorubicin Hydrochloride (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03226249 — Phase 2
~4 spots leftby Dec 2025
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