Duvelisib + Romidepsin/Bortezomib for T-Cell Lymphoma

Recruiting in Palo Alto (17 mi)

+12 other locations

Steven M. Horwitz, MD - MSK Lymphoma ...

Overseen bySteven M. Horwitz, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

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.

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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

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Treatment Details

Interventions

Bortezomib (Proteasome inhibitor)
Duvelisib (PI3K inhibitor)
Romidepsin (Histone deacetylase inhibitor)

Trial OverviewThe 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

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

Bortezomib is already approved in Canada, Japan for the following indications: