This study is being done to determine if two new drugs can shrink or eliminate classical Hodgkins lymphoma.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
1000mg/m2 IV, 30 mins D1, D8
40mg daily PO, D1-D4
75mg/m2 IV, 1 hour, D1
Concord Repatriation General Hospital
Concord, New South Wales, Australia
RECRUITINGComplete 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
Progression-free survival
Time frame: 52 months
Event-free survival
Time frame: 52 months
Overall survival
Time frame: 52 months
Successful stem cell collection rate
Time frame: 52 months
Transplantation rate
Time frame: 52 months
Number and severity of adverse events
Time frame: 52 months
Participant-reported Quality of Life utilizing EORTC QLQ-C30
Time frame: 52 months
Participant-reported toxicity utilizing PRO-CTCAE
Time frame: 52 months
Participant-reported Quality of Life utilizing FACT-LYM evaluating symptoms and concerns associated specifically with the lymphoma disease and/or disease treatment.
Time frame: 52 months
Participant-reported Quality of Life utilizing FACT/GOG-Ntx-Subscale specifically with chemotherapy-induced neuropathy
Time frame: 52 months
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1.8 mg/kg IV, 30 mins, Q21 days
200mg IV, 30 mins, Q 21 days
Shoalhaven Cancer Care Centre
Nowra, New South Wales, Australia
RECRUITINGWollongong Hospital
Wollongong, New South Wales, Australia
RECRUITINGRoyal Adelaide Hospital
Adelaide, South Australia, Australia
RECRUITINGAustin Hospital
Heidelberg, Victoria, Australia
RECRUITINGSir Charles Gairdner Hospital
Perth, Western Australia, Australia
RECRUITINGArthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
RECRUITINGBCCA - Vancouver
Vancouver, British Columbia, Canada
RECRUITINGDr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada
RECRUITINGQEII Health Sciences Centre
Halifax, Nova Scotia, Canada
RECRUITING...and 8 more locations
Health Economics utilizing EQ-5D-5L
Time frame: 52 months
Health Economics financial toxicity utilizing FACIT-COST
Time frame: 52 months