Overview

Obinutuzumab in Combination With GDP Chemotherapy in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Status:
Completed
Trial end date:
2021-02-09
Target enrollment:
Participant gender:
Summary
This is a pilot study to determine the overall survival rate and toxicities of obinutuzumab given with GDP chemotherapy for relapsed or refractory CD20+ aggressive non-Hodgkin lymphoma. Patients who have CD20+ and progressed R-CHOP therapy will be enrolled into the study. About 30 patients are planned to be enrolled from Princess Margaret Cancer Centre. If the enrollment is very slow then additional site may be included. Patients will receive Obinutuzumab +GDP for 3 cycles intravenously. CT scan will be used to evaluate the response rate after cycle 2 and PET-CT will be used after cycle 3. Responders (complete metabolic response, partial metabolic response) should proceed to autologous stem cell transplant (ASCT). Patients who have progressed after three cycles or less are to have their protocol treatment discontinued, with subsequent treatment at investigator discretion. Patients will be followed up to 24 months from transplant done or last chemo. Mandatory tissue submission and optional tissue and blood submission are required for the correlative component of this study.
Phase:
Phase 2
Details
Lead Sponsor:
University Health Network, Toronto
Collaborators:
Hoffmann-La Roche
Ozmosis Research Inc.
Treatments:
Antineoplastic Agents
BB 1101
Cisplatin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Gemcitabine
Obinutuzumab