Trial of Duvelisib in Combination With Either Romidepsin or Bortezomib in Relapsed/Refractory T-cell Lymphomas

Completed · Phase 1

Conditions studied: Lymphoma, Relapsed/Refractory T-cell Lymphomas

In brief

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

Key facts

Study ID

NCT02783625

Run by

Memorial Sloan Kettering Cancer Center

People needed

114

Starts

2016-05-23

Expected to finish

2026-04-21

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically confirmed T-cell lymphomas at the enrolling institution, including stage ≥ Ib CTCL, which has relapsed or progressed after at least one systemic therapy.
• Age ≥ 18
• Previous systemic anti-cancer therapy must have been discontinued at least 3 weeks prior to treatment. For the dose expansion phase, in progressing subjects, a 2 week washout may be allowed after discussion with the MSK Principal Investigator.
• Previous radiation and/or surgery must have been discontinued or completed at least 2 weeks prior to treatment in this study and adverse effects must have resolved to Grade 1 or baseline. Lymph node or other diagnostic biopsies within 2 weeks are not considered exclusionary.
• ° Patients who have received localized RT as part of their immediate prior therapy may be allowed to enroll with shorter washout period after discussion with the MSK Principal Investigator.
• ECOG ≤ 2
• 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
• Measurable disease for dose expansion and lead in phase only.
• Measurable disease defined by:
• Revised International Working Group (Cheson, 2007) Classification for systemic lymphoma or
• Atypical and or malignant lymphocytes quantifiable by flow cytometry or morphology in blood
• or bone marrow mSWAT > 0 or Sezary couny >/= 1000 cells/ul
• Short course systemic corticosteroids for disease control, improvement of performance status or non-cancer indication (< 7 days) must have been discontinued at least 6 days prior to study treatment. Stable ongoing corticosteroid use (≥ 30 days) up to an equivalent dose of 20 mg of prednisone is permissible.
• i) Topical steroids that have been used for > 3 weeks may be continued (CTCL only). All other histologies (not CTCL): Topical steroids use is permissible without restriction
• 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.
• A female of reproductive potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months).

You may not qualify if…

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Pregnant females. (Lactating females must agree not to breast feed while taking the study medications).
• Prior use of duvelisib if discontinued due to toxicity.
• For the romidepsin arm of the study, prior therapy with romidepsin if discontinued due to toxicity.
• For the bortezomib arm of the study, prior therapy with a proteasome inhibitor if discontinued due to toxicity.
• For the bortezomib arm of the study, patients with grade ≥2 peripheral neuropathy.
• History of chronic liver disease, veno-occlusive disease, or current alcohol abuse.
• Administration of a live vaccine within 6 weeks of first dose of study drug.
• Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy)
• Known seropositive and requiring anti-viral therapy for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Subjects with chronic hepatitis B or C as defined as test .
• Subjects with positive Hep B serology. Subjects with a negative HBsAg and a positive HBcAb require an undetectable/negative hepatitis B DNA test (e.g., polymerase chain reaction [PCR] test) to be enrolled, and will require prophylactic antiviral treatment (e.g., F) initiated prior to the first dose of study drug, an continued until approximately 6 to 12 months after completion of study drug(s).
• Patients with positive hepatitis C virus Ab
• Subjects with active EBV unrelated to underlying lymphoma (positive serology for anti-EBV VCA IgM antibody and negative for anti-EBV EBNA IgG antibody, or clinical manifestations and positive EBV PCR consistent with active EBV infection.
• 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.
• Receiving systemic therapy for another primary malignancy (other than T-cell lymphoma)
• Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator.
• Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy (other than T-call lymphoma) is permissible after discussion with the MSK Principal Investigator.
• Known central nervous system or meningeal involvement (in the absence of symptoms, investigation into central nervous system involvement is not required).
• Uncontrolled infection requiring systemic antimicrobials
• The following known cardiac abnormalities:
• Congenital long QT syndrome.
• QTc/QTf interval ≥ 480 milliseconds; unless secondary to pacemaker or bundle branch block.
• Myocardial infarction within 6 months. (Subjects with a history of myocardial infarction within the last 6 to12 months who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate.)
• Other significant ECG abnormalities including 2nd degree atrio- ventricular (AV) block (AV) block type II, 3rd degree AV block.
• Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV (see Appendix B). In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present.

Where it is running

• Stanford University Medical Center — Stanford, California, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Washington School of Medicine in St. Louis — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Memorial Sloan Kettering Cancer Center Basking Ridge (Limited protocol activities) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Cancer Center @ Commack (Limitied protocol activities) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (Limited protocol activities) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau (Limited protocol activities) — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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