RecruitingPhase 2NCT05180097

Pembrolizumab and Brentuximab Vedotin vs GDP and Stem Cell Transplant for Relapsed/Refractory Hodgkin Lymphoma

A Randomized Phase II Study of Pembrolizumab and Brentuximab Vedotin Versus GDP, Followed by High Dose Chemotherapy and Autologous Stem Cell Transplantation for Relapsed/Refractory Classical Hodgkin Lymphoma

Sponsor

Canadian Cancer Trials Group

Enrollment

84 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

Hodgkin Lymphoma

Summary

This study is being done to determine if two new drugs can shrink or eliminate classical Hodgkins lymphoma.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment approaches for Hodgkin lymphoma that has come back or stopped responding to treatment: a newer combination of pembrolizumab (immunotherapy) and brentuximab vedotin (a targeted antibody-drug) versus the current standard of GDP chemotherapy followed by a stem cell transplant. **You may be eligible if:** - You have been diagnosed with classic Hodgkin lymphoma that has relapsed or is no longer responding to treatment after previous chemotherapy containing anthracyclines - You are 18 years or older - You are in good enough health to undergo high-dose chemotherapy and a stem cell transplant (ECOG 0–1) - Your disease is measurable on scans - Your blood counts, liver, and kidney function are within acceptable ranges - You are willing to use effective contraception **You may NOT be eligible if:** - You are unable to be followed up for treatment - You cannot participate in quality-of-life questionnaires - You are unable to consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGemcitabine

1000mg/m2 IV, 30 mins D1, D8

DRUGDexamethasone

40mg daily PO, D1-D4

DRUGCisplatin

75mg/m2 IV, 1 hour, D1

DRUGBrentuximab vedotin

1.8 mg/kg IV, 30 mins, Q21 days

DRUGPembrolizumab

200mg IV, 30 mins, Q 21 days

Locations(18)

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Shoalhaven Cancer Care Centre

Nowra, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Austin Hospital

Heidelberg, Victoria, Australia

Sir Charles Gairdner Hospital

Perth, Western Australia, Australia

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

BCCA - Vancouver

Vancouver, British Columbia, Canada

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, Canada

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

London Health Sciences Centre Research Inc.

London, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

The Jewish General Hospital

Montreal, Quebec, Canada

The Research Institute of the McGill University

Montreal, Quebec, Canada

CIUSSS de l'Estrie - Centre hospitalier

Sherbrooke, Quebec, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05180097

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