A Combination of Rituximab and Varlilumab Immunotherapy in Patients With B-cell Lymphoma

Summary

Participation Requirements

Description

A multicentre, randomised, phase IIa study in participants with relapsed or refractory CD20+ B-cell malignancies. The study will be conducted in 2 stages as follows: Stage 1 - Safety During the safety phase, 6 participants (3 from each Arm and from any subtype) will be treated as detailed in section...

A multicentre, randomised, phase IIa study in participants with relapsed or refractory CD20+ B-cell malignancies. The study will be conducted in 2 stages as follows: Stage 1 - Safety During the safety phase, 6 participants (3 from each Arm and from any subtype) will be treated as detailed in section 6.1. The number of dose limiting toxicities (DLTs) experienced by these participants in each arm after having completed the first cycle will dictate whether the trial will proceed to the second stage. In each arm, if out of these 3 participants 0 experience a DLT, then that arm will proceed to stage 2. In each arm, if out of these 3 participants 1 or 2 experience a DLT, then that arm will be expanded to 3 more participants. If 1 or 2 out of 6 participants experience a dose limiting toxicity, the arm will proceed to Stage 2. If 3 or more out of 6 participants experience a DLT, recruitment for that arm will be stopped. If out of these 3 participants, 3 experience a dose limiting toxicity, recruitment for that arm will be stopped. Initially, the first patient will be entered into the trial. Providing there are no serious or unexplained safety issues during the first 2 weeks, as determined by the Safety Review Committee (SRC), then dosing of subsequent participants will continue as they are identified. Should toxicity findings of concern occur, the SRC may choose to stagger the start of dosing for subsequent participants and/or cohorts. The objective of Stage 2 is to obtain some further information on the safety of the intervention in a larger sample, information on activity (response rate overall and per lymphoma subtype) and feasibility of administrating rituximab and varlilumab together. During Stage 2, recruitment will continue so (including those in Stage 1), there is a total of 10 participants per arm and per disease category (a total of 20 participants per disease category, 40 participants in the trial in total).

Tracking Information