A Phase IIa Clinical Study of Purinostat Mesylate for Injection in Patients With Peripheral T-Cel… (NCT06485219) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase IIa Clinical Study of Purinostat Mesylate for Injection in Patients With Peripheral T-Cell Lymphoma and Cutaneous T-Cell Lymphoma
China50 participantsStarted 2024-04-14
Plain-language summary
Primary Objective To evaluate the preliminary efficacy of Purinostat Mesylate for Injection in patients with relapsed or refractory Peripheral T-Cell Lymphoma (PTCL) and Cutaneous T-Cell Lymphoma (CTCL).
Secondary Objectives
1. To evaluate the safety and tolerability of Purinostat Mesylate for Injection in patients with relapsed or refractory PTCL and CTCL.
2. To evaluate the population pharmacokinetic characteristics of Purinostat Mesylate for Injection in patients with relapsed or refractory PTCL and CTCL.
Exploratory Objective To investigate the relationship between tumor biomarkers and the therapeutic efficacy/safety profile of Purinostat Mesylate for Injection.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The patient fully understands this study, voluntarily participates, and signs the informed consent form (ICF). They are able to communicate well with the investigator and can adhere to the study's visit schedule, treatment plan, laboratory tests, and other study procedures.
✓. Aged ≥18 years, male or female;
✓. Histologically confirmed diagnosis based on the 2022 revised World Health Organization (WHO) classification criteria, including but not limited to the following subtypes:
✓. Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS),
✕. Patients with leukemic PTCL (e.g., adult T-cell leukemia/lymphoma, etc.), or lymphomatous leukemia stage (percentage of lymphoma cells ≥20% on bone marrow examination), or central nervous system (CNS) involvement, or concomitant hemophagocytic syndrome;
What they're measuring
1
Objective remission rate (ORR)
Timeframe: Evaluated every two cycles (Each cycle is 21 days)
✕. Have a history of allergy to similar drugs and excipients of the test drug;
✕. Have received any other antitumor therapy \[including chemotherapy with cytotoxic agents, molecularly targeted therapy, immunotherapy, or other biological therapies within 4 weeks prior to the first use of the test drug, mitomycin or nitrosamines within 6 weeks, small molecule targeted agents at least 2 weeks or at least 5 half-life intervals from the last dose, whichever is longer, and traditional Chinese medicines with antitumor indications at least 2 weeks from the last dose\], and have received the test drug within 4 weeks prior to the first use of the test drug, or have a history of hypersensitivity to similar drugs and excipient components of the test drug; or have a history of allergy to the test drug. Chinese herbal medicines with antitumor indications should be administered at least 2 weeks after the last dose\], and local radiotherapy within 4 weeks prior to the first administration of the test drug;
✕. The presence of persistent Grade 2 or above (CTCAE V5.0 standard) toxicity reaction after the previous treatment (chemotherapy or biotherapy or targeted therapy, etc.), which has not yet recovered to Grade ≤1 level at the time of enrollment (with the exception of alopecia areata);
✕. Vaccination with live attenuated vaccine within 28 days prior to the first dose of study drug or within 60 days of the end of treatment with study drug;
✕. Have received a blood transfusion, recombinant human thrombopoietin, erythropoietin, or granulocyte colony-stimulating factor within 2 weeks prior to the first dose of the investigational drug;
✕. A history of solid organ or allogeneic hematopoietic stem cell transplantation; autologous hematopoietic stem cell transplantation within 3 months prior to the first dose of the investigational drug;
✕. Patients who have received any of the following treatments within 7 days prior to the first dose of the investigational drug: drugs known to be potent inhibitors/inducers of CYP 3A4, drugs known to significantly prolong the QT period;