Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Burkitt Lymphoma
  • Diffuse Large B Cell Lymphoma
  • Lymphoma
  • Non Hodgkin Lymphoma
Type
Interventional
Phase
Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Background: Combination chemotherapy with rituximab has been the mainstay of treatment for CD20-positive B-cell lymphomas. Significant advances have been made in curing aggressive B-cell lymphomas with chemoimmunotherapy, but indolent lymphomas and relapsed/refractory aggressive lymphomas remain mos...

Background: Combination chemotherapy with rituximab has been the mainstay of treatment for CD20-positive B-cell lymphomas. Significant advances have been made in curing aggressive B-cell lymphomas with chemoimmunotherapy, but indolent lymphomas and relapsed/refractory aggressive lymphomas remain mostly incurable with chemotherapy alone. Targeted therapies, aimed at disrupting key survival pathways in lymphoid malignancies, are emerging and showing significant activity in non-Hodgkin lymphoma (NHL) in both the relapsed and first-line settings. Mechanistically based combinations of targeted agents are likely to benefit patients who cannot tolerate or who relapse after or are refractory to standard chemoimmunotherapy. ViPOR-P targets major survival pathways in B-cell lymphomas including BCL-2 (apoptosis); BTK (B-cell receptor signaling and NF-kB); Cereblon (NF-kB) and CD20 with additional genotoxic stress from the anti-mitotic antibody-drug conjugate targeting CD79b, polatuzumab. Objectives: To determine the maximum tolerated dose (MTD) and the safety and toxicity profile of polatuzumab in combination with venetoclax, ibrutinib, prednisone, obinutuzumab and Revlimid(SqrRoot) (lenalidomide) (ViPOR-P) in relapsed/refractory B-cell lymphomas Eligibility: Women and men greater than or equal to 18 years of age ECOG performance status of less than or equal to 2 Histologically or cytologically confirmed relapsed and/or refractory B-cell lymphoma, excluding mantle cell lymphoma (MCL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) Adequate organ function unless dysfunction secondary to lymphoma Design: Open-label, single-center, non-randomized phase 1 study Standard 3 + 3 design will be used to determine the MTD of polatuzumab in combination with venetoclax, ibrutinib, prednisone, obinutuzumab and Revlimid (lenalidomide) (ViPOR-P) in relapsed/refractory B-cell lymphomas A small expansion cohort will be treated at the MTD in a further analysis of safety and preliminary activity. Maximum 6 cycles of combination targeted therapy every 21 days. To explore all dose levels in the phase 1 study and to allow for the possibility of a few screen failures and inevaluable subjects, the accrual ceiling will be set at 32 patients.

Tracking Information

NCT #
NCT04739813
Collaborators
Not Provided
Investigators
Principal Investigator: Christopher J Melani, M.D. National Cancer Institute (NCI)