Duvelisib + Romidepsin/Bortezomib for T-Cell Lymphoma

Recruiting at 12 trial locations

Overseen By Steven M. Horwitz, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Antivirals, Anti-arrhythmics

Disqualifiers: Pregnancy, HIV, Hepatitis, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

114 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test the safety of a study drug called duvelisib.

Research Team

Steven M. Horwitz, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Meet the following laboratory criteria without use of growth factor support or platelet transfusions for 1 week: i) Absolute neutrophil count ≥ 1.0 K/mcl, ii) Platelet count ≥ 80 K/μl (in the expansion cohorts, if thrombocytopenia is due to bone marrow involvement platelet count must be ≥ 50 K/μL), iii) Patients enrolled in the dose escalation phase who are not enrolled on the expansion cohorts must have calculated creatinine clearance ≥ 50ml/min by Cockcroft-Gault formula. Patients enrolled in the Dose Expansion phase must have calculated creatinine clearance ≥ 40ml/min by Cockcroft-Gault formula, iv) Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3 x ULN if documented hepatic involvement with lymphoma, or ≤ 5 x ULN if history of Gilbert's syndrome; AST (SGOT) and ALT (SGPT) ≤ 3 x ULN; ≤ 5 ULN if due to lymphoma involvement

Women of reproductive potential† must have a negative serum or urine β human chorionic gonadotropin (βhCG) pregnancy test. All women of reproductive potential, all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control (e.g. latex condoms) throughout the study and for 30 days after the last dose of study drug

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

Exclusion Criteria

I am receiving or have received therapy to prevent cancer recurrence, not for T-cell lymphoma.

Patients with positive hepatitis C virus Ab

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Standard 3+3 dose escalation to determine the maximum tolerated dose (MTD) of duvelisib with romidepsin and duvelisib with bortezomib

1 cycle (28 days)

Visits on Days 1, 8, 15 for Romidepsin arm; Days 1, 4, 8, 11 for Bortezomib arm

Cohort Expansion

Further assess toxicity and safety, and allow a preliminary assessment of the efficacy of the combination

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bortezomib
• Duvelisib
• Romidepsin

Trial Overview 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.

Participant Groups

Group I: Romidepsin + duvelisib Experimental Treatment 2 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 + duvelisib Experimental Treatment 2 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

Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

Approved in United States as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

Approved in Canada as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

Approved in Japan as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+