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Anti-tumor antibiotic

Immunotherapy for Hodgkin's Lymphoma

Phase 2

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Group 1: Must have newly diagnosed, pathologically confirmed classical Hodgkin Lymphoma (cHL) at Stages IA, IB and IIA without bulky disease

Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA, IIIEB, IIIB, IVA and IVB with measurable disease per investigator assessment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 8 years

Awards & highlights

Study Summary

This trial will test a new immunotherapy drug in children and young adults with Hodgkin's Lymphoma who haven't responded well to other treatments.

Who is the study for?

This trial is for children and young adults with classical Hodgkin Lymphoma who are slow to respond to initial chemotherapy. They must have measurable disease, adequate organ function, and agree to specific contraception if applicable. Exclusions include severe allergies to study drugs, certain heart conditions, prior treatments with similar agents or vaccines close to the start of the trial, active infections like HIV or hepatitis, and other health issues that could interfere.Check my eligibility

What is being tested?

The trial tests pembrolizumab combined with standard chemotherapy in patients who haven't responded well initially. It aims to see how safe this combination is and how effective it is at treating Hodgkin Lymphoma in these particular patients.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation in various organs (like lungs), infusion-related reactions which can range from mild discomfort to more serious symptoms during drug administration, fatigue, digestive problems including nausea or diarrhea, blood disorders like anemia or clotting issues, increased risk of infections due to immune suppression.

Eligibility Criteria

Inclusion Criteria

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

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I have been newly diagnosed with early-stage classical Hodgkin Lymphoma without bulky disease.

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I have been newly diagnosed with advanced Hodgkin lymphoma.

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I can do most activities but need help with some, whether I am under or over 16 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 8 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

Objective Response Rate (ORR) in SER Participants By Risk Group (Low, High) as Assessed by Blinded Independent Central Review (BICR)

Secondary outcome measures

EFS in Rapid Early Responder (RER) Participants By Risk Group (Low, High) as Assessed by Investigator

Event-Free Survival (EFS) in SER Participants By Risk Group (Low, High) as Assessed by BICR

Exposure to Radiotherapy (RT) in SER Participants By Risk Group (Low, High)

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pembrolizumab + COPDAC-28 (Group 2)Experimental Treatment8 Interventions

After receiving two 4-week cycles of OEPA (vincristine, etoposide/etopophos, prednisone/prednisolone and doxorubicin) induction therapy, SER participants in Group 2 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) Q3W, in combination with 4 cycles of COPDAC-28 chemotherapy (cyclophosphamide 500 mg/m^2 on Days 1 and 8, vincristine 1.5 mg/m^2 with maximum single dose 2 mg on Days 1 and 8, prednisone/prednisolone 40 mg/m^2/day divided in 3 doses on Days 1 to 15, dacarbazine 250 mg/m^2 on Days 1 to 3; cycle frequency Q4W). SERs in Group 2 will receive RT if they have a positive Positron Emission Tomography (PET) response after completing COPDAC-28 chemotherapy.

Group II: Pembrolizumab + AVD (Group 1)Experimental Treatment6 Interventions

After receiving two 4-week cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) induction therapy, SER participants in Group 1 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) on Day 1 of each 3-week cycle (Q3W) in combination with two cycles of AVD chemotherapy (doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2 and dacarbazine 375 mg/m^2 on Days 1 and 15; cycle frequency every 4 weeks [Q4W]). All SERs in Group 1 will receive radiotherapy (RT) after completing AVD chemotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiotherapy (RT)

2017

Completed Phase 2

~110

dacarbazine

2010

Completed Phase 3

~5030

etoposide

1994

Completed Phase 3

~9300

cyclophosphamide

1994

Completed Phase 3

~8140

vincristine

2005

Completed Phase 4

~3840

doxorubicin

2005

Completed Phase 3

~9130

pembrolizumab

2017

Completed Phase 3

~5750

vinblastine

2010

Completed Phase 3

~1490

bleomycin

2010

Completed Phase 1

~60

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,581,482 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,054,231 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,140 Total Patients Enrolled

Media Library

Bleomycin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03407144 — Phase 2

Hodgkin's Lymphoma Research Study Groups: Pembrolizumab + AVD (Group 1), Pembrolizumab + COPDAC-28 (Group 2)

Hodgkin's Lymphoma Clinical Trial 2023: Bleomycin Highlights & Side Effects. Trial Name: NCT03407144 — Phase 2

Bleomycin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03407144 — Phase 2

Frequently Asked Questions

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

What are the specific inclusion criteria for this trial?

"The requirements to take part in this clinical trial are that the patient has hodgkin disease and is between 3 and 25 years old. Currently, there are 340 people who meet these criteria and have signed up for the study."

Answered by AI

Are participants being recruited for this research at present?

"Yes, this information is accurate. The trial was first posted on April 9th, 2018 and has been seeking patients since then."

Answered by AI

In how many different locations is this trial taking place?

"This clinical trial is recruiting patients from 44 sites across the United States. The locations are based in Buffalo, New york and Aurora along with other locations. It is important to select the location nearest you to minimize travel demands if you enroll."

Answered by AI

How many test subjects are included in this experiment?

"That is correct, the online information specifies that the trial is recruiting. The clinical trial was posted on April 9th, 2018 and was edited on October 28th, 2022. 340 participants are needed in total from 44 different locations."

Answered by AI

Does cyclophosphamide pose any serious risks to human health?

"There is some clinical data supporting the safety of cyclophosphamide, but none for efficacy; thus it received a score of 2."

Answered by AI

Does this research only pertain to young adults?

"To be eligible for this particular clinical trial, applicants must fall between the ages of 3 and 25. In contrast, there are 742 other trials that focus on patients under 18 years old and 3670 studies geared towards senior citizens aged 65 or older."

Answered by AI

To your knowledge, has anything like this been done before?

"Cyclophosphamide has been under medical scrutiny since 1997 when Alfacell first sponsored a study. Since the original trial of 300 patients, this drug has progressed to Phase 3 and is now approved. There are 2373 active studies involving cyclophosphamide across 84 countries and 4027 cities."

Answered by AI

What are the most common illnesses that doctors use cyclophosphamide to address?

"While it is most often used to target advanced testicular cancer, cyclophosphamide has also been taken to manage conditions such as pheochromocytomas, ulcerative colitis, and varicella-zoster virus acute retinal necrosis."

Answered by AI

Do you have any more information about other experiments with cyclophosphamide?

"The immunosuppressive drug cyclophosphamide was first evaluated in 1997 at Spectrum Health Hospital. Since then, there have been 2535 completed clinical trials worldwide. Currently, 2373 studies are recruiting patients with a large portion of these based out of Buffalo, New york."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)

2018. "Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03407144.

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