Spots Global Cancer Trial Database for Study of VIP152, Venetoclax, and Prednisone (VVIP) in Relapsed/Refractory Lymphoid Malignancies

Study Description

Brief Summary: Background: Non-Hodgkin lymphomas are blood cancers that can be difficult to treat. They can also return after treatment. Examples include diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma (PTCL). More effective treatments are needed for these diseases. Objective: To test the safety of a study drug (VIP152) in combination with other drugs used to treat people with aggressive blood cancers. Eligibility: People aged 18 years or older diagnosed with DLBCL, PTCL, or related blood cancers. The cancers must have either not responded to treatment or returned after treatment. Design: Participants will undergo screening. They will have a physical exam with scans and blood and urine tests. They will have imaging scans and tests of their heart function. They may also provide a bone marrow aspiration or biopsy. Participants may provide a saliva sample for DNA testing. Participants will receive study treatment in cycles. Each cycle is 21 days. Participants will take two drugs by mouth at home once a day on days 1-10 of each cycle. On days 2 and 9 they will come to the clinic to receive VIP152. This drug will be administered through a small plastic tube with a needle placed in a vein. On day 11, participants will receive a fourth medication as an injection under the skin. They will rest and recover on days 12-21. Screening tests will be repeated periodically throughout the study period. Treatment will continue for up to 24 cycles. Participants will have follow-up visits for up to 5 years.

Detailed Description: Background: * High unmet medical need for relapsed/refractory non-Hodgkin lymphoma (NHL) after exhausting chemotherapy and/or chemo-immunotherapy regimens * Targeted therapies aimed at disrupting cell death pathway in hematologic malignancies are emerging and showing significant activity in both the relapsed and first-line settings * VIP152 is a selective inhibitor of PTEFb/CDK9 and is expected to show efficacy in tumor indications that overexpress MYC and MCL-1. VIP152 monotherapy has demonstrated a mild toxicity profile and preliminary efficacy in Phase 1 studies in advanced cancer * The combination of VIP152 with venetoclax and prednisone (VVIP) targets major cell-death pathways in lymphoid malignancies (BCL-2 and MCL-1) and may overcome chemo-resistance and/or single drug resistance to venetoclax Objectives: * Phase 1: To determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and the safety and toxicity profile of the combination of VIP152 with venetoclax and prednisone (VVIP) in relapsed/refractory lymphoid malignancies * Phase 2: To determine the complete response (CR) rate of the combination of VIP152 with venetoclax and prednisone (VVIP) in R/R lymphoid malignancies

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

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