VIP152 + Venetoclax + Prednisone for Blood Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new combination of drugs to treat aggressive blood cancers, such as non-Hodgkin lymphomas, which are difficult to manage and often recur after treatment. The goal is to determine the safety of the study drug, VIP152 (an experimental treatment), when combined with venetoclax and prednisone. Individuals with specific types of blood cancers, like diffuse large B-cell lymphoma or peripheral T-cell lymphoma, that have not responded to or have returned after treatment may be suitable candidates. Participants will receive the treatment in cycles and attend clinic visits for monitoring over several months. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it does exclude participants who are taking certain strong or moderate CYP3A inhibitors or inducers within 14 days before starting the study drugs. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that using VIP152 with venetoclax and prednisone is safe for people with certain recurring or hard-to-treat blood cancers. VIP152 targets a specific protein in cancer cells and has been found safe for the heart. Studies with 57 patients showed it does not significantly affect heart function.
Venetoclax is FDA-approved for some types of leukemia. In safety studies, a few patients experienced side effects like infections, but these were uncommon. For instance, a large study found that only 3.1% of participants had serious infections. Some patients needed dose adjustments due to side effects like low white blood cell counts, but these issues were manageable.
Overall, evidence suggests that using VIP152 and venetoclax with prednisone is safe for treating aggressive blood cancers.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they combine VIP152, venetoclax, and prednisone in a novel way to tackle blood cancers. Unlike traditional therapies that might only target one aspect of the cancer, this combo leverages VIP152's unique ability to inhibit CDK9, a key protein that helps cancer cells survive. By combining this with venetoclax, which promotes cancer cell death, and the anti-inflammatory effects of prednisone, the treatment aims to enhance effectiveness and potentially improve outcomes. This multi-pronged approach could lead to more robust and sustained responses compared to existing options.
What evidence suggests that this trial's treatments could be effective for blood cancers?
Research has shown that VIP152, when used alone, yields promising results in treating advanced cancers with manageable side effects. In this trial, participants will receive a combination of VIP152, venetoclax, and prednisone, believed to be more effective against aggressive blood cancers like diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma (PTCL). Venetoclax targets and kills cancer cells, while prednisone reduces inflammation and manages the immune system. This combination aims to improve outcomes for patients whose cancers have not responded to other treatments or have recurred. Early studies suggest this combination could offer new hope for those facing these challenging blood cancers.46789
Who Is on the Research Team?
Christopher J Melani, M.D.
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
Adults diagnosed with aggressive blood cancers like DLBCL or PTCL, which have not responded to treatment or returned after treatment. Participants must be over 18, understand the study and consent to it, agree to use effective contraception if of childbearing potential, and cannot be breastfeeding. They should have adequate organ function and no active infections or other cancer treatments within specific time frames before the trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive VIP152, venetoclax, and prednisone in 21-day cycles, with clinic visits on days 2 and 9 for VIP152 administration and day 11 for an injection
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Prednisone
- Venetoclax
- VIP152
Prednisone is already approved in United States, European Union, Canada for the following indications:
- Allergic reactions
- Asthma
- Blood disorders
- Cancer
- Eye problems
- Immune system disorders
- Inflammatory conditions
- Multiple sclerosis
- Organ transplantation
- Rheumatoid arthritis
- Skin conditions
- Allergic reactions
- Asthma
- Blood disorders
- Cancer
- Eye problems
- Immune system disorders
- Inflammatory conditions
- Multiple sclerosis
- Organ transplantation
- Rheumatoid arthritis
- Skin conditions
- Allergic reactions
- Asthma
- Blood disorders
- Cancer
- Eye problems
- Immune system disorders
- Inflammatory conditions
- Multiple sclerosis
- Organ transplantation
- Rheumatoid arthritis
- Skin conditions
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor