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Anti-tumor antibiotic, Alkylating agents, Anti-metabolites

Pembrolizumab + ICE Chemotherapy for Hodgkin's Lymphoma

Q: What maladies does Pembrolizumab usually treat?

<p>Pembrolizumab is a favored treatment for <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, and can also be taken to manage malignant skin melanomas, merkel cell <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a>, and recurrent cervical cancers.</p>

Phase 2

Waitlist Available

Led By Jane N. 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 Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Patients must have histologically confirmed diagnosis of classical Hodgkin lymphoma including nodular sclerosis, mixed cellularity, lymphocytic-rich, and lymphocyte depleted subtypes by the 4th edition of the World Health Organization (WHO) Classification of Tumors of Hematopoietic and Lymphoid Tissues published in 2008

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial will look at the feasibility, safety and efficacy of the 'ICE' regimen of chemotherapy in combination with pembrolizumab as a way to achieve a complete remission prior to stem cell transplant in patients with Relapsed/Refractory Hodgkin Lymphoma.

Who is the study for?

This trial is for patients with relapsed or refractory Hodgkin Lymphoma who've had at least one but no more than two prior chemotherapy treatments and have not used immune checkpoint inhibitors. They must be in good physical condition (ECOG status 0 or 1), have proper organ and bone marrow function, agree to use birth control, and understand the study's consent. Exclusions include recent other treatments, known CNS involvement, prior stem cell transplant, active infections or severe diseases that could affect safety assessments.Check my eligibility

What is being tested?

The trial tests Pembrolizumab combined with 'ICE' chemotherapy (ifosfamide, carboplatin, etoposide) for those with relapsed/refractory Hodgkin Lymphoma. Pembrolizumab is FDA-approved for some cancers but not yet for this lymphoma type; ICE is approved separately. The goal is to achieve complete remission before a potential stem cell transplant.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation of organs, infusion-related reactions like fever or chills during treatment administration, fatigue from energy depletion due to therapy impact on the body's normal functions; digestive issues including nausea and diarrhea; blood disorders like anemia or clotting problems; increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

My Hodgkin lymphoma diagnosis is confirmed and matches specific types.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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 Rate

Secondary outcome measures

Event Free Survival (EFS)

Incidence of Adverse Events

Overall Survival (OS)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab, etoposide, carboplatin, ifosfamide)Experimental Treatment5 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1, etoposide IV over 60 minutes on days 1-3 of courses 1-2, carboplatin IV over 60 minutes on day 2 of courses 1-2, and ifosfamide IV over 24 hours on day 2 of courses 1-2. Pembrolizumab in combination with ICE chemotherapy repeats every 21 days for 2 courses, patients will then receive pembrolizumab as monotherapy on course 3.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

FDA approved

Pembrolizumab

FDA approved

Carboplatin

FDA approved

Beta-D-Glucose

Not yet FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,188 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,887 Previous Clinical Trials

5,054,931 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,446 Total Patients Enrolled

Media Library

Ifosfamide, Carboplatin, Etoposide (Anti-tumor antibiotic, Alkylating agents, Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03077828 — Phase 2

Hodgkin's Lymphoma Research Study Groups: Treatment (pembrolizumab, etoposide, carboplatin, ifosfamide)

Hodgkin's Lymphoma Clinical Trial 2023: Ifosfamide, Carboplatin, Etoposide Highlights & Side Effects. Trial Name: NCT03077828 — Phase 2

Ifosfamide, Carboplatin, Etoposide (Anti-tumor antibiotic, Alkylating agents, Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03077828 — Phase 2

Frequently Asked Questions

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

What maladies does Pembrolizumab usually treat?

"Pembrolizumab is a favored treatment for melanoma, and can also be taken to manage malignant skin melanomas, merkel cell cancer, and recurrent cervical cancers."

Answered by AI

Has prior research been conducted into the efficacy of Pembrolizumab?

"Pembrolizumab was initially studied at the City of Hope Comprehensive Cancer Centre in 1997, with 2793 trials completed to date. Currently 2355 active clinical studies are ongoing, primarily based out of Hackensack, New jersey."

Answered by AI

Is this trial currently accessible to those seeking treatment?

"According to the research posted on clinicaltrials.gov, this trial has concluded its patient recruitment phase. First announced in April of 2017 and last updated on April 30th 2021, it is no longer looking for participants; however there are a plethora of other trials seeking volunteers at present."

Answered by AI

Has the FDA sanctioned Pembrolizumab for therapeutic use?

"Our analysis at Power yielded a safety rating of 2 for Pembrolizumab, as the drug is currently in Phase 2 trials which have provided preliminary data on its security but no evidence yet concerning efficacy."

Answered by AI

How many locations have been enlisted to carry out this experiment?

"This clinical trial is accepting patients from Hackensack University Medical Center in Hackensack, Winship Cancer Institute of Emory University in Atlanta, and the University of Rochester in Rochester. Additionally, there are 6 more sites enrolling participants for this medical study."

Answered by AI

How many individuals are being recruited to participate in this medical experiment?

"Unfortunately, this trial is no longer accepting participants. The first post was made on April 21st 2017 and the last edit occured on April 30th 2021. For those seeking other clinical trials, there are currently 3,110 studies searching for volunteers who have lymphocyte issues and 2,355 exams recruiting people to take pembrolizumab."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

Jane N. Winter 2017. "Pembrolizumab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03077828.

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