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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 belowSelect...
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:Select...
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
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
Romidepsin
2011
Completed Phase 2
~790
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,976 Previous Clinical Trials
599,386 Total Patients Enrolled
156 Trials studying Lymphoma
9,155 Patients Enrolled for Lymphoma
Dana-Farber Cancer InstituteOTHER
1,110 Previous Clinical Trials
358,184 Total Patients Enrolled
61 Trials studying Lymphoma
2,971 Patients Enrolled for Lymphoma
Stanford UniversityOTHER
2,484 Previous Clinical Trials
17,516,007 Total Patients Enrolled
45 Trials studying Lymphoma
25,346 Patients Enrolled for Lymphoma
Steven Horwitz, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
7 Previous Clinical Trials
2,698 Total Patients Enrolled
7 Trials studying Lymphoma
2,698 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am receiving or have received therapy to prevent cancer recurrence, not for T-cell lymphoma.I stopped taking romidepsin before because of its side effects.I stopped taking duvelisib because it was causing harmful side effects.I stopped a proteasome inhibitor treatment because of side effects.I do not have an active CMV infection requiring treatment.I am currently fighting an infection that needs strong medication.I have a history of liver disease or I currently abuse alcohol.I have Hepatitis B but meet the criteria for treatment in this study.I have an active Epstein-Barr virus infection not related to my lymphoma.I am currently receiving treatment for another cancer besides T-cell lymphoma.My cancer has spread to my brain or its coverings.I have moderate to severe nerve damage not related to the spine.I have had surgery or have a condition that could affect how drugs are absorbed in my body.I have HIV, HBV, or HCV and need antiviral treatment.My T-cell lymphoma has worsened after at least one treatment.I stopped my cancer treatment at least 3 weeks ago.I can take care of myself and perform daily activities.My cancer can be measured by tests.I don't have serious heart conditions or uncontrolled high blood pressure.I am 18 years old or older.I finished any cancer surgery or radiation at least 2 weeks ago and any side effects have mostly gone away.I stopped short-term steroids 6 days ago or have been on stable steroids for 30 days.I can use topical steroids for my skin cancer without restrictions.I am a woman capable of becoming pregnant.I have not received a live vaccine in the last 6 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Romidepsin + duvelisib
- Group 2: Bortezomib + duvelisib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.