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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

Must not have

History of other active malignancy affecting compliance

Symptomatic heart failure, unstable angina, or cardiac arrhythmia

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have another active cancer that could interfere with treatment.

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I do not have heart problems like failure, chest pain, or irregular heartbeat.

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I currently have an active CMV or COVID-19 infection.

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My heart function is within normal limits.

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I do not have any active or recent major infections.

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I recently had a stem cell transplant or have active graft-versus-host disease.

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I do not have serious liver disease or active hepatitis B or C.

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I cannot take medications by mouth due to absorption issues.

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.