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No longer recruiting (closed or complete)Last updated: 4 September 2025

HD11: This study is being done to determine if two new drugs can shrink or eliminate relapsed or refractory classical Hodgkin's 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

HD11

Clinical summary

Summary

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

The standard of care treatment for people with relapsed/refractory Hodgkin's lymphoma is salvage treatment with GDP chemotherapy, which consists of gemcitabine, dexamethasone and cisplatin. This treatment can reduce symptoms and may stop the lymphoma from growing for a few months or longer. 

The researchers are doing this study because they want to find out if treatment with immunotherapy (called pembrolizumab) and an antibody-drug conjugate (called Brentuximab vedotin) is better or worse than the current GDP standard of care treatment.

Eligible participants will be randomly allocated to one of two treatment arms.

In the Active Comparator Arm, participants will receive standard of care treatment with GDP. This will consist of gemcitabine given via IV on Days 1 and 8 of every treatment cycle, dexamethasone given orally once daily, and cisplatin given via IV in Day 1 of every treatment cycle.

In the Experimental Arm, participants will receive brentuximab vedotin plus pembrolizumab. Both will be given via IV every 21 days.

Conditions

This trial is treating people with classic Hodgkin's lymphoma that is relapsed or refractory after treatment with chemotherapy

Eligibility

Inclusion

  • 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

  • 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)

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Canadian Cancer Trials Group

Scientific 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

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