CompletedPhase 1

Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas

United States5 participantsStarted 2021-09-01

Plain-language summary

This phase I trial finds the appropriate parsaclisib dose level in combination with romidepsin for the treatment of T-cell lymphomas that have come back (relapsed) or that have not responded to standard treatment (refractory). The other goals of this trial are to find the proportion of patients whose cancer is put into complete remission or significantly reduced by romidepsin and parsaclisib, and to measure the effectiveness of romidepsin and parsaclisib in terms of patient survival. Romidepsin blocks certain enzymes (histone deacetylases) and acts by stopping cancer cells from dividing. Parsaclisib is a PI3K inhibitor. The PI3K pathway promotes cancer cell proliferation, growth, and survival. Parsaclisib, thus, may stop the growth of cancer cells by blocking PI3K enzymes needed for cell growth. Giving romidepsin and parsaclisib in combination may work better in treating relapsed or refractory T-cell lymphomas compared to either drug alone.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \>= 18 years * Able to understand and voluntarily sign a consent form * Biopsy proven diagnosis of PTCL or CTCL * Relapsed/refractory PTCL, progressing after at least one line of systemic therapy (for anaplastic large cell lymphoma \[ALCL\], must have had prior treatment with brentuximab vedotin). OR * Relapsed/Refractory CTCL, that progressed on at least 2 lines of skin-directed (topical) therapy and/or one line of systemic therapy. Pre-treatment with mogamulizumab and/or brentuximab vedotin (in the presence of CD30 positive disease) is NOT required as a criterion for eligibility. Skin-directed therapies include, but are not limited to topical steroids, topical chemotherapy, imiquimod, narrow band ultraviolet B (UVB), psoralen plus ultraviolet A photochemotherapy (PUVA), total skin electron beam radiation, and extracorporeal photopheresis * Mycosis fungoides with large cell transformation is eligible * Performance status (Eastern Cooperative Oncology Group \[ECOG\]) 0-2 * Life expectancy \>= 90 days * Patient must have at least stage IB CTCL (\> 10% eBSA) or PTCL with disease defined by a nodal area of at least 1.5 cm in long dimension, extranodal disease of at least 1 cm in long dimension, or fludeoxyglucose F-18 - positron emission tomography (FDG-PET) avid disease (Deauville score = 5) * Absolute neutrophil count (ANC) \>= 1,000/mm\^3 * Platelet count \>= 100,000/mm\^3 * Calculated creatinine clearance \>= 50mL/min (Cockcroft-Gault method) * Asp…

What they're measuring

Maximum tolerated dose (MTD) of parsaclisib

Timeframe: Cycles 3-5 (each cycle is 28 days)

Trial details

NCT IDNCT04774068

SponsorWalter Hanel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-27