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Proteasome inhibitor

Duvelisib + Romidepsin/Bortezomib for T-Cell Lymphoma

Phase 1

Waitlist Available

Led By Steven Horwitz, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Pathologically confirmed T-cell lymphomas at the enrolling institution, including stage ≥ Ib CTCL, which has relapsed or progressed after at least one systemic therapy

ECOG ≤ 2

Must not have

Subject with active CMV (positive serology for anti-CMV IgM antibody and negative for anti-CMV IgG antibody and positive CMV PCR with clinical manifestations consistent with active CMV infection) and requiring therapy will be excluded from participation in the study. Carriers will be monitored per institutional guidelines

Uncontrolled infection requiring systemic antimicrobials

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if duvelisib is safe for humans.

Who is the study for?

Adults over 18 with relapsed or refractory T-cell lymphomas, including stage ≥ Ib CTCL, after at least one systemic therapy. Participants must have certain blood counts and organ function levels, no serious medical conditions that would prevent consent, not be pregnant or breastfeeding, agree to use birth control, and have measurable disease.

What is being tested?

The trial is testing the safety of duvelisib in combination with either romidepsin or bortezomib for treating T-cell lymphomas. It's looking at how well these drug combinations work when previous treatments haven't been successful.

What are the potential side effects?

Potential side effects may include reactions related to the immune system, liver problems indicated by changes in bilirubin levels and liver enzymes (AST/ALT), possible blood disorders reflected in neutrophil and platelet counts, as well as risks associated with kidney function measured by creatinine clearance.

Eligibility Criteria

Inclusion Criteria

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

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My T-cell lymphoma has worsened after at least one treatment.

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I can take care of myself and perform daily activities.

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I am 18 years old or older.

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I am a woman capable of becoming pregnant.

Exclusion Criteria

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

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I do not have an active CMV infection requiring treatment.

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I am currently fighting an infection that needs strong medication.

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I have a history of liver disease or I currently abuse alcohol.

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I have Hepatitis B but meet the criteria for treatment in this study.

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I have an active Epstein-Barr virus infection not related to my lymphoma.

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I am currently receiving treatment for another cancer besides T-cell lymphoma.

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My cancer has spread to my brain or its coverings.

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I have moderate to severe nerve damage not related to the spine.

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I have had surgery or have a condition that could affect how drugs are absorbed in my body.

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I have HIV, HBV, or HCV and need antiviral treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

maximum tolerated dose (MTD)

Secondary study objectives

overall response rate (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Romidepsin + duvelisibExperimental Treatment2 Interventions

Romidepsin/duvelisib: Cycle 1 and beyond Days 1, 8, 15\* Romidepsin IVPB over 4 hours, days 1, 8, 15 duvelisib by mouth twice daily, days 1-28

Group II: Bortezomib + duvelisibExperimental Treatment2 Interventions

Bortezomib/duvelisib: Cycle 1 and beyond Days 1, 4, 8, and 11\* Bortezomib subcutaneous injection, days 1, 4, 8, 11\*\* duvelisib by mouth twice daily, days 1-28

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bortezomib

2005

Completed Phase 3

~1410

duvelisib

2015

Completed Phase 1

~10