drugset / Trial / NCT02750670

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

NCT02750670 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2017-03-15
Primary completion
2020-09-09
Completion
2021-02-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Obinutuzumab Monoclonal antibody 1000 mg Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Dexamethasone Small molecule 40 mg Oral
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous

Indications