Study of VIP152, Venetoclax, and Prednisone (VVIP) in Treating Difficult or Returning Blood Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05371054

Provider View

This clinical trial is testing a new combination of drugs, including VIP152, to see if they are safe and effective in treating aggressive blood cancers like Non-Hodgkin lymphomas that have not responded to previous treatments or have returned.

Patient Parameters

Program Overview

This study is exploring a new treatment for aggressive blood cancers, such as Non-Hodgkin lymphomas, that are hard to treat or have come back after treatment. The trial will test the safety of a drug called VIP152, used with other medications, to see if it can help control these cancers. Participants will receive the treatment in cycles, with regular check-ups and tests to monitor their health and the treatment's effects.

Description

This study is designed to find better treatments for blood cancers like Non-Hodgkin lymphomas that have returned or are resistant to current therapies. The trial will test a combination of drugs, including VIP152, venetoclax, and prednisone, to see if they can effectively target cancer cells and improve patient outcomes.

Participants will go through a screening process, including physical exams, scans, and blood tests, to ensure they meet the study criteria. The treatment will be given in 21-day cycles, with two oral medications taken at home and VIP152 administered at the clinic. Participants will also receive an injection on the 11th day of each cycle, followed by a rest period.

The study aims to determine the safest and most effective dose of the drug combination and to evaluate how well it works in shrinking tumors. Participants will be closely monitored throughout the study, with follow-up visits for up to five years to track their progress and health.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with specific types of blood cancers, such as DLBCL or PTCL, that have not responded to or have returned after treatment.
  • Must have measurable disease that can be tracked through exams, lab tests, or imaging.
  • Good overall health with adequate organ function, as determined by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.
  • Participants with hepatitis B or C must have a negative viral load and agree to additional monitoring.
  • Ability to understand and sign a consent form, and willingness to follow study procedures.

Exclusion Criteria

  • Currently receiving other cancer treatments or investigational drugs.
  • Recent chemotherapy, targeted therapy, or antibody treatments within two weeks before starting the study.
  • Recent stem cell transplant or active graft-versus-host disease.
  • Active infections or recent major infections requiring hospitalization.
  • HIV-positive or active hepatitis B or C infections.
  • Significant heart problems or abnormal heart rhythms.
  • Other active cancers that could interfere with the study.
  • Conditions affecting the ability to take oral medications.
  • Uncontrolled medical or psychiatric conditions that could affect participation.

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