Pembrolizumab and Brentuximab Vedotin vs GDP and Stem Cell Transplant for Relapsed/Refractory Hod… (NCT05180097) | Clinical Trial Compass
RecruitingPhase 2
Pembrolizumab and Brentuximab Vedotin vs GDP and Stem Cell Transplant for Relapsed/Refractory Hodgkin Lymphoma
Australia84 participantsStarted 2022-11-01
Plain-language summary
This study is being done to determine if two new drugs can shrink or eliminate classical Hodgkins lymphoma.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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/…
What they're measuring
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