A Combination of Rituximab and Varlilumab Immunotherapy in Patients With B-cell Lymphoma
Status:
Active, not recruiting
Trial end date:
2022-09-30
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Collaborators:
Cancer Research UK Celldex Therapeutics Oxford University Hospitals NHS Trust Plymouth Hospitals NHS Trust The Christie NHS Foundation Trust University Hospital Plymouth NHS Trust