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Anti-metabolites

Treatment (Pembrolizumab and AVD) for Hodgkin's Lymphoma

Phase 2

Recruiting

Led By Jane N Winter, MD

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 measurable fludeoxyglucose (FDG)-avid disease by Lugano 2014 response criteria

Patients must be age ≥ 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial tests a combination of a drug that boosts the immune system and chemotherapy to treat classical Hodgkin lymphoma.

Who is the study for?

Adults with untreated classical Hodgkin lymphoma, stages I-IV, who are in good physical condition (ECOG 0-1) and have proper organ function. They must not be pregnant or breastfeeding, agree to use contraception, and have no history of severe allergies to trial drugs or similar compounds. Excluded are those with prior treatments for cHL, active CNS metastases, other cancers requiring treatment, uncontrolled illnesses or infections.Check my eligibility

What is being tested?

The trial is testing the effectiveness of pembrolizumab (a monoclonal antibody that activates the immune system against cancer cells) followed by chemotherapy drugs doxorubicin, vinblastine and dacarbazine in treating patients with classical Hodgkin lymphoma.See study design

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in various organs. Chemotherapy can lead to hair loss, nausea/vomiting, fatigue and increased risk of infection due to lowered blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer shows up on special PET scans.

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I am 18 years old or older.

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My Hodgkin lymphoma is at an advanced stage or at an early stage with high risk factors.

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My condition has not been treated before.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My white blood cell count is healthy, not due to cancer in my bone marrow.

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My kidney function, measured by creatinine or GFR, is within the required range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Rate of complete response (CR)

Secondary outcome measures

Assess the CR rate at the end of PEM induction by PET-CT i

Efficacy of reduced cycles of treatment with doxorubicin (adriamycin) vinblastine, doxorubicin (AVD) for patients with CR

Incidence of adverse events

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Pembrolizumab and AVD)Experimental Treatment10 Interventions

INDUCTION: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Treatment repeats repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo disease assessment. Patients with a response complete 3 additional cycles of pembrolizumab, undergo disease assessment and proceed to consolidation. Patients without response or with progressive disease proceed to consolidation. CONSOLIDATION: Patients receive doxorubicin IV, vinblastine IV and dacarbazine IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity for 2 to 6 cycles dependent upon response and disease type. Patients undergo echocardiography/MUGA scan, CT scan, PET scan and blood sample collection throughout the study and may undergo tumor biopsy during screening.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2720

Positron Emission Tomography

2008

Completed Phase 2

~2240

Vinblastine

1998

Completed Phase 3

~5260

Biopsy

2014

Completed Phase 4

~1090

Doxorubicin

2012

Completed Phase 3

~7940

Echocardiography

2013

Completed Phase 4

~11670

Biospecimen Collection

2004

Completed Phase 2

~1700

Pembrolizumab

2017

Completed Phase 2

~2010

Dacarbazine

2005

Completed Phase 3

~5110

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,411 Total Patients Enrolled

Northwestern UniversityLead Sponsor

1,589 Previous Clinical Trials

917,057 Total Patients Enrolled

Jane N Winter, MDPrincipal InvestigatorNorthwestern University

Frequently Asked Questions

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

To what extent could exposure to Pembrolizumab and AVD be detrimental for patients?

"Our team at Power has assigned a safety rating of 2 out of 3 to the Treatment (Pembrolizumab and AVD) due to existing evidence suggesting its security, yet none demonstrating effectiveness."

Answered by AI

Is this trial actively seeking participants?

"Clinicaltrials.gov records report that this trial, which first launched on December 31st 2023 and was last modified on the 8th of December in the same year is no longer recruiting patients. Thankfully, 1718 other studies are still actively seeking participants at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab Followed by Chemotherapy for the Treatment of Patients With Classical Hodgkin Lymphoma

Jane N. Winter 2024. "Pembrolizumab Followed by Chemotherapy for the Treatment of Patients With Classical Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06164275.