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

Who is this study for? Patients with relapsed/refractory classical Hodgkin lymphoma
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• History of classic Hodgkin lymphoma by histopathology and now have relapsed or refractory disease after anthracycline-containing chemotherapy and eligible for high dose chemotherapy and autologous stem cell transplant

• 18 years of age or greater

• ECOG performance status 0-1

• Clinically and/or radiologically measurable disease as per the Lugano 2014 classification

• Life expectancy \> 90 days

• Absolute neutrophils ≥1.0 x 10\^9/L; Platelets ≥75 x 10\^9/L; Hemoglobin ≥80 g/L: Bilirubin ≤1.50 x UNL; AST and ALT ≤2.50 x UNL; Serum creatinine \<1.55 x UNL or Creatinine clearance ≥30 mL/min

• Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires and/or health utility in either English or French

• Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate.

• Participants must be accessible for treatment and follow-up.

• In accordance with CCTG policy, protocol treatment is to begin within 2 working days of participant enrollment

• Women/men of childbearing potential must have agreed to use a highly effective contraceptive method during the study plus approximately 6 months after treatment completion

• All patients must have a tumour block from their primary diagnostic biopsy and relapse/refractory biopsy if available and the centre/pathologist must have agreed to release the block or recently cut slides for correlative analysis if the participant has consented. If the primary diagnostic biopsy is not accessible, the original pathology report should be submitted for review and a biopsy from the relapse/refractory disease must be submitted.

Locations
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Concord Repatriation General Hospital
RECRUITING
Concord
Austin Hospital
RECRUITING
Heidelberg
Shoalhaven Cancer Care Centre
RECRUITING
Nowra
Sir Charles Gairdner Hospital
RECRUITING
Perth
Wollongong Hospital
RECRUITING
Wollongong
Canada
Arthur J.E. Child Comprehensive Cancer Centre
RECRUITING
Calgary
QEII Health Sciences Centre
RECRUITING
Halifax
Juravinski Cancer Centre at Hamilton Health Sciences
RECRUITING
Hamilton
London Health Sciences Centre Research Inc.
RECRUITING
London
The Jewish General Hospital
RECRUITING
Montreal
The Research Institute of the McGill University
RECRUITING
Montreal
Ottawa Hospital Research Institute
RECRUITING
Ottawa
Allan Blair Cancer Centre
RECRUITING
Regina
CIUSSS de l'Estrie - Centre hospitalier
RECRUITING
Sherbrooke
Dr. H. Bliss Murphy Cancer Centre
RECRUITING
St. John's
University Health Network
RECRUITING
Toronto
BCCA - Vancouver
RECRUITING
Vancouver
Contact Information
Primary
Annette Hay
ahay@ctg.queensu.ca
613-533-6430
Backup
Lois Shepherd
lshepherd@ctg.queensu.ca
613-533-6430
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 84
Treatments
Active_comparator: GDP
Active_comparator: Brentuximab vedotin + Pembrolizumab
Sponsors
Collaborators: Merck Sharp & Dohme LLC, Pfizer, Australasian Leukaemia and Lymphoma Group
Leads: Canadian Cancer Trials Group

This content was sourced from clinicaltrials.gov

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