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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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 2
~550
Imidazole
Not yet FDA approved
Positron Emission Tomography
2008
Completed Phase 2
~2240
Computed Tomography
2017
Completed Phase 2
~2720
Doxorubicin
FDA approved
Vinblastine
FDA approved
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,027 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,201 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,242 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any locations in North America that are actively engaged with this experiment?

"Currently, 4 distinct sites are hosting the trial. These include Atlanta, Chicago and Stanford among others. To reduce travel-related hassles during your participation in this study, we advise you select a location nearest to you."

Answered by AI

For which conditions are FDG-PET/CT, pembrolizumab and chemotherapy most commonly prescribed?

"Malignant neoplasms can be treated with a variety of medical interventions, such as FDG-PET/CT scans, pembrolizumab, and chemotherapy. Moreover, these treatments have been found to be beneficial for patients suffering from unresectable melanoma, microsatellite instability high states, or neuroblastoma (nb)."

Answered by AI

How successful have pembrolizumab, chemotherapy and FDG-PET/CT been in past trials?

"Currently, 1,217 studies are being conducted to assess Treatment (FDG-PET/CT, pembrolizumab, chemotherapy); of these trials, 235 have advanced into the last phase. Although most investigations take place in Houston, Texas there is a total of 59,775 clinical trial sites around the world that are pursuing this treatment."

Answered by AI

Could you please explain the risks associated with this combination of FDG-PET/CT, pembrolizumab, and chemotherapy?

"Based on our evaluation, Treatment (FDG-PET/CT, pembrolizumab, chemotherapy) was assigned a value of 2. This is because the Phase 2 trial provides evidence that this treatment is safe but lacks any data regarding its efficacy."

Answered by AI

Is this research accepting new participants at the present time?

"This research project, which was unveiled on November 9th 2017 and last revised on July 1st 2020, is not currently recruiting patients. However, there are 2918 other trials actively looking for volunteers at this time."

Answered by AI

How extensive is the current enrolment for this clinical research project?

"Unfortunately, this trial has ceased recruitment activities. It first appeared on the 11th of September 2017 but was last updated on July 1st 2020. For those searching for similar trials, there are presently 1701 active studies recruiting Hodgkin's lymphoma patients and 1217 clinical trials investigating Treatment (FDG-PET/CT, pembrolizumab, chemotherapy)."

Answered by AI

Is this research a groundbreaking endeavor?

"At the present, 1217 treatments (including FDG-PET/CT, pembrolizumab, and chemotherapy) are actively being studied in 73 countries across 3454 cities. The earliest of such studies was conducted by Alfacell back in 1997 with 300 participants who completed phase 3 drug approval; since then 1677 similar trials have been launched."

Answered by AI
~4 spots leftby Apr 2025