Recruiting
Phase 2

New Drugs

Sponsor:

Canadian Cancer Trials Group

Code:

NCT05180097

Conditions

Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gemcitabine

Dexamethasone

Cisplatin

Brentuximab vedotin

Pembrolizumab

Study Details

Brief summary:

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

Conditions

Hodgkin Lymphoma

Study ID

NCT05180097

Start date

Nov 1, 2022

Status verified date

Aug, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Participants who have received prior salvage systemic therapy for their relapsed or refractory disease.
  • History of peripheral neuropathy or dyspnea ≥ grade 2
  • Participants with a history of other malignancies except: adequately treated non-melanoma skin cancer and superficial bladder cancer, curatively treated in-situ cancer of the cervix or breast, or localized excised prostate cancer, other solid tumours curatively treated with no evidence of disease for > 3 years
  • History of active CNS disease
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at doses more than 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first and any dose of trial treatment
  • Has active autoimmune disease that has required systemic treatment in the past 3 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) or history of allogeneic transplantation. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • Known history of human immunodeficiency virus (HIV), active Hepatitis C Virus infection, active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (IV) antibiotics. Participants that are Hepatitis B core antibody positive are eligible if they are HBV DNA negative and are concurrently treated with anti-viral therapy. Participants with a past history of hepatitis C who have eradicated the virus are eligible
  • Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, angina, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
  • Documented history of cerebral vascular event (stroke or transient ischemic attack)
  • History of progressive multifocal leukoencephalopathy (PML).
  • Any serious active disease or co-morbid medical condition, including psychiatric illness, judged by the local investigator to preclude safe administration of the planned protocol treatment or required follow-up
  • Any other serious intercurrent illness, life-threatening condition, organ system dysfunction, or medical condition judged by the local investigator to compromise the subject's safety (for example): active, uncontrolled bacterial, fungal or viral infection; clinically significant cardiac dysfunction or cardiovascular disease
  • Participants who have been vaccinated with live, attenuated vaccines within 4 weeks of enrollment
  • Pregnant or lactating females, or women/men of childbearing potential not willing to use an adequate method of birth control for the duration of the study through 6 months after the last dose of trial treatment
  • Participants are not eligible if they have had a prior infusion reaction to the study drugs or their components > grade 2
  • Participant has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • Participant has had an allogenic tissue/solid organ transplant
  • Concurrent or within the previous 4 weeks of randomization, treatment with other investigational drugs or anti-cancer therapy
  • Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A one-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy)

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: GDP

active comparator: Brentuximab vedotin + Pembrolizumab

Interventions

Gemcitabine

1000mg/m2 IV, 30 mins D1, D8

Dexamethasone

40mg daily PO, D1-D4

Cisplatin

75mg/m2 IV, 1 hour, D1

Brentuximab vedotin

1.8 mg/kg IV, 30 mins, Q21 days

Pembrolizumab

200mg IV, 30 mins, Q 21 days

Primary outcome measure

  • Complete response rate by PET Deauville criteria (score 1-3) of pembrolizumab and brentuximab vedotin compared to standard GDP (gemcitabine, dexamethasone, cisplatin) given as salvage therapy [ Time Frame: 52 months ]

Central Contacts and Locations

Central contacts

Annette Hay

613-533-6430ahay@ctg.queensu.ca

Lois Shepherd

613-533-6430lshepherd@ctg.queensu.ca

Locations

Arthur J.E. Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Contacts

Robert Puckrin

403 944-5222

BCCA - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Kerry J. Savage

604 877-6000

Dr. H. Bliss Murphy Cancer Centre

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1B 3V6

Contacts

Jacqueline Costello

709 777-6545

QEII Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 1V7

Contacts

Mary-Margaret Keating

902 473-7006

Juravinski Cancer Centre at Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contacts

Amaris Balitsky

905 387-9495

London Health Sciences Centre Research Inc.

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Joy Elise Mangel

519 685-8500

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Isabelle Bence-Bruckler

613 737-8152

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

John Kuruvilla

416 946-2827

The Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Nathalie Johnson

514 398-8307

The Research Institute of the McGill University

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Kelly Davison

514 934-1934

CIUSSS de l'Estrie - Centre hospitalier

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Stephanie Desilets

819 346-1110

Allan Blair Cancer Centre

Recruiting

Regina, Saskatchewan, Canada, S4T 7T1

Contacts

Muhammad Salim

306 766-2691

More Information

Sponsor

Canadian Cancer Trials Group

Last update posted

Feb 2, 2026

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Canadian Cancer Trials Group on 2026-02-02.