VIP152 + Venetoclax + Prednisone for Blood Cancers

CJ
NM
Overseen ByNCI Medical Oncology Referral Office
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

CJ

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

Ability to understand and sign a written informed consent document
Agreement to use highly effective contraception for women and men of reproductive potential
Breastfeeding participants must discontinue breastfeeding during study treatment
See 7 more

Exclusion Criteria

Active receipt of other anti-cancer investigational agents
I do not have another active cancer that could interfere with treatment.
HIV-positive participants
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

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

Up to 72 weeks (24 cycles)
2 visits (in-person) per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years
Periodic visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Prednisone
  • Venetoclax
  • VIP152
Trial Overview The trial is testing VIP152 in combination with venetoclax and prednisone (VVIP) for safety and effectiveness against relapsed/refractory lymphoid malignancies. Patients will take medications orally at home and receive VIP152 intravenously at a clinic during 21-day cycles for up to 24 cycles, followed by up to five years of follow-up visits.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Cohort 2/Phase 2: Arm 2 Dose ExpansionExperimental Treatment10 Interventions
Group II: Cohort 1/Phase 1: Arm 1 Dose EscalationExperimental Treatment10 Interventions

Prednisone is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Prednisone for:
🇪🇺
Approved in European Union as Prednisone for:
🇨🇦
Approved in Canada as Prednisone for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Cabazitaxel, when combined with prednisone, significantly improves overall survival in patients with hormone-refractory metastatic prostate cancer who have previously been treated with docetaxel, as shown in the pivotal TROPIC trial.
The treatment also enhances progression-free survival and response rates for tumor and PSA levels, while maintaining an acceptable safety profile, with common side effects including hematological issues and diarrhea.
Cabazitaxel: a guide to its use in hormone-refractory metastatic prostate cancer.Keating, GM.[2021]
Switching from prednisone to dexamethasone in patients with metastatic castration-resistant prostate cancer who have progressed on abiraterone acetate plus prednisone may be beneficial, as suggested by the review of four clinical studies.
Potential candidates for this steroid switch include patients with PSA progression but no clinical or radiological progression, those without severe side effects from CYP-17 inhibition, and individuals unfit for chemotherapy or radium-223.
Corticosteroid switch after progression on abiraterone acetate plus prednisone.Roviello, G., Sobhani, N., Corona, SP., et al.[2020]
Venetoclax is a highly effective treatment for relapsed or refractory chronic lymphocytic leukemia (CLL), achieving response rates of about 80% in clinical trials involving 240 patients from 2011 to 2016.
While venetoclax has an acceptable safety profile, common side effects include neutropenia and diarrhea, and there is a risk of tumor lysis syndrome (TLS), which can be managed through careful dose ramp-up and patient education, leading to no reported TLS events in ongoing trials.
Venetoclax: Management and Care for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia .Brumbaugh Paradis, H., Alter, D., Llerandi, D.[2018]

Citations

Study of VIP152, Venetoclax, and Prednisone (VVIP) in ...VIP152 monotherapy has demonstrated a mild toxicity profile and preliminary efficacy in Phase 1 studies in advanced cancer; The combination of VIP152 with ...
Study of VIP152, Venetoclax, and Prednisone (VVIP) in ...To test the safety of a study drug (Enitociclib (VIP152) in combination with other drugs used to treat people with aggressive blood cancers. Eligibility: People ...
Study of VIP152, Venetoclax, and Prednisone (VVIP) in ...Objective: To test the safety of a study drug (Enitociclib (VIP152) in combination with other drugs used to treat people with aggressive blood cancers.
Abstract PO-008: Phase I/II study of VIP152 (enitociclib ...Based on this preclinical data, we hypothesized that the combination of VIP152 with venetoclax and prednisone (VVIP) would result in acceptable ...
Study of VIP152, Venetoclax, and Prednisone (VVIP) in Rel...VIP152 monotherapy has demonstrated a mild toxicity profile and preliminary efficacy in Phase 1 studies in advanced cancer; The combination of ...
Abstract PO-008: Phase I/II study of VIP152 (enitociclib ...The combination of VIP152 with venetoclax and prednisone (VVIP) would result in acceptable safety and improved efficacy in R/R lymphoid malignancies.
P1269: VIP152 IS A NOVEL CDK9 INHIBITOR WITH ...VIP152 is a potent and selective CDK9 inhibitor currently in development with a favorable cardiac safety profile.
VIP152 is a selective CDK9 inhibitor with pre-clinical in ...These data suggest that VIP152 is a highly selective inhibitor of CDK9 that represents an attractive new therapy for CLL.
Vincerx Pharma Presents Preclinical and Clinical Data on ...Pooled cardiac safety data from 57 patients demonstrated that VIP152 does not prolong QTc interval after single or multiple doses (5-30 mg).
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security