HD11

HD11 Details
Status: Open
Activation Date: 2022MAR03
Phase: II

Description: A Randomized Phase II Trial of Pembrolizumab and Brentuximab Vedotin versus GDP Followed by High Dose Chemotherapy and Autologous Stem Cell Transplantation for Relapsed/Refractory Classical Hodgkin Lymphoma

Eligibility: Patients 18 years and up must have had a history of classic Hodgkin lymphoma by histopathology and have relapsed or refractory disease after anthracycline-containing chemotherapy. Patients must have ECOG performance of 0-1 and are eligible for high dose chemotherapy and autologous stem cell transplant. No prior salvage systemic therapy for relapsed/refractory disease. No history of peripheral neuropathy or dyspnea > grade 2, active CNS disease, cerebral vascular event, progressive multifocal leukoencephalopathy (PML), (non-infectious) pneumonitis requiring steroids, HIV, nor other malignancies (with exceptions). No diagnosis of immunodeficiency, no active autoimmune disease requiring treatment in past 3 years. No active Hepatitis C or B infection or any uncontrolled active systemic infection. No clinically significant cardiovascular disease. Any serious active disease or co-morbid medical condition. No live vaccination. No allogenic tissue/solid organ transplant. No RT within 14 days.

Objective: Primary:To determine the 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. Secondary: PFS, EFS, OS, successful stem cell collection rate, transplantation rate, toxicity and safety, patient reported quality of life, health economics including patient reported financial toxicity and cost per quality adjusted life years Exploratory: To identify markers of disease response and/or tumour biology that provide prognostic or predictive information, to evaluate PET radiomic parameters beyond those identified in the Lugano 2014 response criteria, and to evaluate response and outcome using the RECIL and LYRIC criteria

Participation: Open to member centres

Lay Description: This is an open label, multi-centre, randomized phase II trial of novel combination therapy followed by autologous stem cell transplantation in patients with relapsed and refractory classical Hodgkin lymphoma, conducted by the CCTG with support of Merck and Seattle Genetics. The trial will compare standard gemcitabine, dexamethasone, and cisplatin (GDP) versus pembrolizumab and brentuximab as salvage therapy prior to transplant. FDG-PET review performed locally to assess response and then central review to be performed at the end of study

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Disease Site	Trial Code	Patients Accrued	Patients - Blocks	Patients - Slides	Patients - Blocks and/or Slides
HEMATOLOGIC	HD11	Open Trial	11	26	36

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(Core size is 0.6 mm)

Disease Site	Trial Code	Patients Accrued	TMA Blocks	Patients on TMA Blocks
HEMATOLOGIC	HD11	Open Trial	0	0

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Disease Site	Trial Code	Patients Accrued	Patients - Whole Blood	Patients - Cellular Component of Blood	Patients - DNA extracted from Blood	Patients - RNA extracted from Blood	Patients - Plasma	Patients - Serum	Patients - Urine	Patients - Buccal
HEMATOLOGIC	HD11	Open Trial	2	0	0	0	2	2	0	0