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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
maximum tolerated dose (MTD)
Secondary outcome measures
overall response rate (ORR)

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 2
~1140
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
1,927 Previous Clinical Trials
591,293 Total Patients Enrolled
154 Trials studying Lymphoma
8,594 Patients Enrolled for Lymphoma
Dana-Farber Cancer InstituteOTHER
1,071 Previous Clinical Trials
340,250 Total Patients Enrolled
59 Trials studying Lymphoma
2,297 Patients Enrolled for Lymphoma
Stanford UniversityOTHER
2,373 Previous Clinical Trials
17,327,848 Total Patients Enrolled
44 Trials studying Lymphoma
25,300 Patients Enrolled for Lymphoma

Media Library

Bortezomib (Proteasome inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02783625 — Phase 1
Lymphoma Research Study Groups: Romidepsin + duvelisib, Bortezomib + duvelisib
Lymphoma Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT02783625 — Phase 1
Bortezomib (Proteasome inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02783625 — Phase 1

Frequently Asked Questions

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

Are any fresh participants being sought for this trial?

"This clinical trial has concluded its recruitment. Initially posted on May 1st 2016, the study was last updated on September 20th 2022. For those seeking alternative trials, 1733 studies for lymphoma and 174 ones concerning duvelisib are currently enrolling patients."

Answered by AI

How many individuals are being administered care in this trial?

"Unfortunately, this clinical trial is not currently accepting candidates. Initially posted on May 1st 2016 and last updated on September 20th 2022, it has been placed in stasis for the time being. That said, there are 1733 medical studies searching for participants with lymphoma and 174 trials exploring duvelisib that may be open to applicants."

Answered by AI

In what maladies is duvelisib typically prescribed?

"Duvelisib is a viable therapy for refractory anemias, mantle cell lymphoma (mcl), and follicular lymphoma."

Answered by AI

Are there any American research centers participating in this endeavor?

"The trial encompasses 7 different medical sites, with Memorial Sloan Kettering Cancer Center in New york at the forefront. Additionally, Memoral Sloan Kettering Westchester (Limited protocol activities) can be found in Harrison and Memorial Sloan Kettering Nassau (Limited protocol activities) is located in Uniondale. The other 4 locations are also participating."

Answered by AI

Are there any other studies that have evaluated the efficacy of duvelisib?

"First tested by the National Institutes of Health Clinical Center in 2004, duvelisib has since been subject to 438 completed clinical trials. Currently, 174 studies are actively recruiting participants across New york and New jersey."

Answered by AI

Are there any observed safety concerns with duvelisib treatments?

"There is little information to support the safety of duvelisib, so it has been given a score of 1 on our scale."

Answered by AI
~1 spots leftby May 2024