Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05180097




Registration number
NCT05180097
Ethics application status
Date submitted
17/12/2021
Date registered
6/01/2022

Titles & IDs
Public title
Pembrolizumab and Brentuximab Vedotin vs GDP and Stem Cell Transplant for Relapsed/Refractory Hodgkin Lymphoma
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
Secondary ID [1] 0 0
HD11
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Cisplatin
Treatment: Drugs - Brentuximab vedotin
Treatment: Drugs - Pembrolizumab

Active comparator: GDP -

Active comparator: Brentuximab vedotin + Pembrolizumab -


Treatment: Drugs: Gemcitabine
1000mg/m2 IV, 30 mins D1, D8

Treatment: Drugs: Dexamethasone
40mg daily PO, D1-D4

Treatment: Drugs: Cisplatin
75mg/m2 IV, 1 hour, D1

Treatment: Drugs: Brentuximab vedotin
1.8 mg/kg IV, 30 mins, Q21 days

Treatment: Drugs: Pembrolizumab
200mg IV, 30 mins, Q 21 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
52 months
Secondary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
52 months
Secondary outcome [2] 0 0
Event-free survival
Timepoint [2] 0 0
52 months
Secondary outcome [3] 0 0
Overall survival
Timepoint [3] 0 0
52 months
Secondary outcome [4] 0 0
Successful stem cell collection rate
Timepoint [4] 0 0
52 months
Secondary outcome [5] 0 0
Transplantation rate
Timepoint [5] 0 0
52 months
Secondary outcome [6] 0 0
Number and severity of adverse events
Timepoint [6] 0 0
52 months
Secondary outcome [7] 0 0
Participant-reported Quality of Life utilizing EORTC QLQ-C30
Timepoint [7] 0 0
52 months
Secondary outcome [8] 0 0
Participant-reported toxicity utilizing PRO-CTCAE
Timepoint [8] 0 0
52 months
Secondary outcome [9] 0 0
Participant-reported Quality of Life utilizing FACT-LYM evaluating symptoms and concerns associated specifically with the lymphoma disease and/or disease treatment.
Timepoint [9] 0 0
52 months
Secondary outcome [10] 0 0
Participant-reported Quality of Life utilizing FACT/GOG-Ntx-Subscale specifically with chemotherapy-induced neuropathy
Timepoint [10] 0 0
52 months
Secondary outcome [11] 0 0
Health Economics utilizing EQ-5D-5L
Timepoint [11] 0 0
52 months
Secondary outcome [12] 0 0
Health Economics financial toxicity utilizing FACIT-COST
Timepoint [12] 0 0
52 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Newfoundland and Labrador
Country [4] 0 0
Canada
State/province [4] 0 0
Nova Scotia
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Canada
State/province [7] 0 0
Saskatchewan

Funding & Sponsors
Primary sponsor type
Other
Name
Canadian Cancer Trials Group
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Seagen Inc.
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Australasian Leukaemia and Lymphoma Group
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kerry Savage
Address 0 0
BCCA-Vancouver Cancer Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Annette Hay
Address 0 0
Country 0 0
Phone 0 0
613-533-6430
Fax 0 0
Email 0 0
ahay@ctg.queensu.ca
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05180097