Study of VIP152, Venetoclax, and Prednisone (VVIP) in Relapsed/Refractory Lymphoid Malignancies

Lymphoma Clinical Trial

Official title: Phase 1/2 Study of VIP152, Venetoclax, and Prednisone (VVIP) in Relapsed/Refractory Lymphoid Malignancies

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Hematologic Malignancies
• Hematologic Neoplasms
• Lymphoid Malignancies
• Lymphoma
• Neoplasms
• NHL
• Non-Hodgkin Lymphoma

• NCT number: NCT05371054
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Contact: NCI Medical Oncology Referral Office
• Phone: (888) 624-1937
• Email: ncimo_referrals@nih.gov
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 5, 2023
• Completion date: March 10, 2025