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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2017
A total of 40 participants will be recruited, with 20 participants in each of the following subcategories: A) High grade lymphoma (DLBCL, FL grade 3b, transformed FL) (n=20) B) Low grade lymphoma (e.g. FL grade 1, 2 or 3a, MZL, MCL) (n=20) The main purpose for having two experimental treatment arms is to provide a comparator for the translational endpoints, i.e. to assess whether the differences observed are due to the addition of varlilumab to rituximab. The only difference between Arm A and Arm B is the delay in administration of varlilumab in cycle 1, which is on Day 2 in Arm A and Day 8 in Arm B. As the post-treatment tissue collection occurs on Day 7/8, prior to administration of varlilumab in Arm B, samples will be obtained from participants that have either been treated with rituximab alone, or both rituximab and varlilumab. To minimise any potential risks to the patient as a result of a repeat biopsy on Day 7/8, a prerequisite for entry to the trial is that the participants must have accessible sites for biopsy. Difference in response rates between Arm A and Arm B are not expected.
Epistemonikos ID: 5c9835d0610ef92571208ae1f95966bda5b8d94d
First added on: May 21, 2024