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Corticosteroid

VIP152 + Venetoclax + Prednisone for Blood Cancers

Phase 1 & 2

Recruiting

Led By Christopher J Melani, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years

Participants positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have negative viral load

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from the date of study enrollment during therapy, after completion of therapy from initiation of therapy to first response q3, 4, 6 and 12 months for post-treatment years 1, 2, 3, and 4-5, respectively, for up to 5 years after the last participant

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat aggressive blood cancers that have not responded to other treatments, or have returned after treatment.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system suppression such as increased risk of infection, digestive issues from oral drugs taken at home, possible liver dysfunction due to medication interactions, fatigue from anemia management drugs like G-CSF used during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have hepatitis but my viral load is undetectable.

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My cancer is a type of lymphoid malignancy confirmed by lab tests.

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I can take care of myself but might not be able to do heavy physical work.

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My aggressive B-cell lymphoma or PTCL has returned or is not responding to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from the date of study enrollment during therapy, after completion of therapy from initiation of therapy to first response q3, 4, 6 and 12 months for post-treatment years 1, 2, 3, and 4-5, respectively, for up to 5 years after the last participant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from the date of study enrollment during therapy, after completion of therapy from initiation of therapy to first response q3, 4, 6 and 12 months for post-treatment years 1, 2, 3, and 4-5, respectively, for up to 5 years after the last participant

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from the date of study enrollment during therapy, after completion of therapy from initiation of therapy to first response q3, 4, 6 and 12 months for post-treatment years 1, 2, 3, and 4-5, respectively, for up to 5 years after the last participant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse events

Complete response (CR) rate

Secondary outcome measures

Duration of Response (DOR)

Event-free survival (EFS)

Overall Response Rate (ORR)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: 2/Phase 2: Arm 2 Dose ExpansionExperimental Treatment4 Interventions

VVIP- VIP152 and venetoclax at the RP2D with prednisone at fixed doses

Group II: 1/Phase 1: Arm 1 Dose EscalationExperimental Treatment4 Interventions

VVIP-VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the MTD and RP2D of VIP152 and venetoclax

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

prednisone

1999

Completed Phase 3

~10920

venetoclax

2021

Completed Phase 2

~750

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,658 Previous Clinical Trials

40,924,512 Total Patients Enrolled

Christopher J Melani, M.D.Principal InvestigatorNational Cancer Institute (NCI)

5 Previous Clinical Trials

371 Total Patients Enrolled

Media Library

Prednisone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05371054 — Phase 1 & 2

Non-Hodgkin's Lymphoma Research Study Groups: 1/Phase 1: Arm 1 Dose Escalation, 2/Phase 2: Arm 2 Dose Expansion

Non-Hodgkin's Lymphoma Clinical Trial 2023: Prednisone Highlights & Side Effects. Trial Name: NCT05371054 — Phase 1 & 2

Prednisone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05371054 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can new patients still sign up to participate in this research?

"This particular clinical trial is not recruiting patients at this time. Based on the information provided by clinicaltrials.gov, which includes the posting date (11/23/2022) and last update (11/17/2022), it can be inferred that the study has completed recruitment. There are 4226 other trials open for patient enrollment currently."

Answered by AI

What are the most important goals of this medical study?

"The primary outcome of this clinical trial is to monitor adverse events over a period of time. Secondary objectives include progression-free survival (PFS), time to response (TTR), and duration of response (DOR)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study of VIP152, Venetoclax, and Prednisone (VVIP) in Relapsed/Refractory Lymphoid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05371054.