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Hodgkin LymphomaPhase 2NCT05180097

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

A Phase 2 study testing Gemcitabine, Dexamethasone and Cisplatin in people with Hodgkin Lymphoma, run by Canadian Cancer Trials Group at 18 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
Gemcitabine, Dexamethasone and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
18 sitesin 2 countries
Study dates
1 Nov 2022to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

18 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Annette Hay contact

613-533-6430

ahay@ctg.queensu.ca

Lois Shepherd contact

613-533-6430

lshepherd@ctg.queensu.ca

18 sites in 2 countries

Canada12 sites, 12 recruiting

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

    Robert Puckrin, 403 944-5222

    Recruiting

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

    Mary-Margaret Keating, 902 473-7006

    Recruiting

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

    Amaris Balitsky, 905 387-9495

    Recruiting

  • London Health Sciences Centre Research Inc.

    London, Ontario, N6A 5W9

    Joy Elise Mangel, 519 685-8500 ext. 52391

    Recruiting

  • The Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Nathalie Johnson, 514 398-8307

    Recruiting

  • The Research Institute of the McGill University

    Montreal, Quebec, H4A 3J1

    Kelly Davison, 514 934-1934 ext. 31558

    Recruiting

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

    Isabelle Bence-Bruckler, 613 737-8152

    Recruiting

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

    Muhammad Salim, 306 766-2691

    Recruiting

  • CIUSSS de l'Estrie - Centre hospitalier

    Sherbrooke, Quebec, J1H 5N4

    Stephanie Desilets, 819 346-1110 ext. 74816

    Recruiting

  • Dr. H. Bliss Murphy Cancer Centre

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

    Jacqueline Costello, 709 777-6545

    Recruiting

  • University Health Network

    Toronto, Ontario, M5G 2M9

    John Kuruvilla, 416 946-2827

    Recruiting

  • BCCA - Vancouver

    Vancouver, British Columbia, V5Z 4E6

    Kerry J. Savage, 604 877-6000 ext. 2641

    Recruiting

Other trials in Canada

Australia6 sites, 6 recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

    Danielle Blunt, 613 707-4413

    Recruiting

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

    Nicole WongDoo

    Recruiting

  • Austin Hospital

    Heidelberg, Victoria, 3084

    Eliza Hawkes, 613 949-6986

    Recruiting

  • Shoalhaven Cancer Care Centre

    Nowra, New South Wales, 2541

    Shrinivas Desai

    Recruiting

  • Sir Charles Gairdner Hospital

    Perth, Western Australia, 6009

    Katharine Lewis

    Recruiting

  • Wollongong Hospital

    Wollongong, New South Wales, 2500

    Shrinivas Desai

    Recruiting

Other trials in Australia

About this study

Official title: 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

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

Read the detailed description

Treatment given to participants whose disease has not responded to (refractory) or returned (relapsed) after previous treatment is known as salvage treatment.

The standard of care for participants who are not in a study is salvage treatment with gemcitabine, dexamethasone and cisplatin (GDP). This treatment can reduce symptoms and may stop the lymphoma from growing for a few months or longer. This standard treatment is approved by Health Canada

We are doing this study because we want to find out if treatment with Pembrolizumab and Brentuximab vedotin is better or worse than the standard of care for this type of cancer, classical Hodgkin lymphoma. The standard of care is defined as care most people get for your cancer.

Being tested
Gemcitabine, Dexamethasone, Cisplatin, Brentuximab vedotin, Pembrolizumab
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05180097
Study groupRoleWhat they receive
GDPActive comparatorNot described
Receives: Drug: Gemcitabine; Drug: Dexamethasone; Drug: Cisplatin
Brentuximab vedotin + PembrolizumabActive comparatorNot described
Receives: Drug: Brentuximab vedotin; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 52 months

Secondary outcomes (12)

  1. Progression-free survival

    Measured: 52 months

  2. Event-free survival

    Measured: 52 months

  3. Overall survival

    Measured: 52 months

  4. Successful stem cell collection rate

    Measured: 52 months

  5. Transplantation rate

    Measured: 52 months

  6. Number and severity of adverse events

    Measured: 52 months

  7. Participant-reported Quality of Life utilizing EORTC QLQ-C30

    Measured: 52 months

  8. Participant-reported toxicity utilizing PRO-CTCAE

    Measured: 52 months

  9. Participant-reported Quality of Life utilizing FACT-LYM evaluating symptoms and concerns associated specifically with the lymphoma disease and/or disease treatment.

    Measured: 52 months

  10. Participant-reported Quality of Life utilizing FACT/GOG-Ntx-Subscale specifically with chemotherapy-induced neuropathy

    Measured: 52 months

  11. Health Economics utilizing EQ-5D-5L

    Measured: 52 months

  12. Health Economics financial toxicity utilizing FACIT-COST

    Measured: 52 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2022
  2. Study start1 Nov 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05180097
Sponsor's protocol ID
HD11
Status last verified
Aug 2025
First submitted
17 Dec 2021
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, Dexamethasone and Cisplatin in people with Hodgkin Lymphoma, run by Canadian Cancer Trials Group at 18 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Annette Hay (613-533-6430, ahay@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05180097.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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