Undersøgelse af ONO-4685 hos patienter med recidiverende eller refraktær T-celle lymfom
Et åbent, multicenter, ikke-randomiseret fase I-dosiseskaleringsstudie for at undersøge sikkerheden, tolerabiliteten, farmakokinetikken og den foreløbige effektivitet af ONO-4685 givet som monoterapi hos patienter med recidiverende eller refraktær T-celle lymfom
This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 in patients with relapsed or refractory T cell Lymphoma
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- University of Alabama at Birmingham
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California
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Duarte, California, Forenede Stater, 91010
- City of Hope
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Orange, California, Forenede Stater, 92868
- University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
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Palo Alto, California, Forenede Stater, 94304
- Stanford Cancer Institute
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06519
- Yale Cancer Center
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Winship Cancer Institute of Emory University
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Dana Farber Cancer Institute
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Michigan
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Detroit, Michigan, Forenede Stater, 48201
- Karmanos Cancer Institute
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine in St. Louis
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- Hackensack University Medical Center - John Theurer Cancer Center
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New York
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Buffalo, New York, Forenede Stater, 14263
- Roswell Park Cancer Institute
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New York, New York, Forenede Stater, 10065
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Forenede Stater, 10032
- New York-Presbyterian/Columbia University Irving Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC)
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28204
- Novant Health Presbyterian Medical Center
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Ohio
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Oregon Health & Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania - Perelman Center
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University - Ingram Cancer Center
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Texas
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Dallas, Texas, Forenede Stater, 75390
- UT Southwestern Medical Center
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Houston, Texas, Forenede Stater, 77030
- MD Anderson
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Washington
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Seattle, Washington, Forenede Stater, 91809
- Fred Hutchinson Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria
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Patients aged ≥ 18 years at time of screening
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Written informed consent by the patient or the patients' legally authorized representative prior to screening
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Patients with histologically or cytologically confirmed diagnosis of one of the following subtypes of T-cell lymphoma:
- Peripheral T-cell lymphoma (PTCL): Angioimmunoblastic T-cell lymphoma (AITL), PTCL, not otherwise specified (PTCL-NOS), nodal PTCL with T-follicular helper (TFH) and follicular T-cell lymphoma (FTCL)
- Cutaneous T-cell lymphoma (CTCL) (stages II-B, III, and IV): Mycosis fungoides (MF) and Sezary syndrome (SS)
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Patients must have received at least 2 prior systemic therapies
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Patients with PTCL must have at least 1 measurable lesion (Cheson BD, 2014)
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Patients with CTCL must have assessable disease by response criteria for CTCL (Olsen EA, 2011)
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Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 0-2
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Life expectancy of at least 3 months
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Adequate bone marrow, renal and hepatic functions
Exclusion Criteria:
- Patients with central nervous system (CNS) involvement
- Patients with Adult T-cell leukemia/lymphoma (ATLL)
- Prior allogeneic stem cell transplant
- Prior treatment with ONO-4685, anti-PD-1, anti-PD-L1, anticytotoxic T lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Prior allogeneic and autologous chimeric antigen receptor (CAR) T-cell therapy
- Patients with malignancies (other than T-cell lymphoma) except for completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, or any other malignancies that has not relapsed for at least 2 years
- History of severe allergy or hypersensitivity to any monoclonal antibodies, other therapeutic proteins or corticosteroid (e.g., dexamethasone)
- History of infection with Mycobacterium tuberculosis within 2 years prior to the first dose of study treatment
- Patients with systemic and active infection including human immunodeficiency virus (HIV), hepatitis B or C virus infection
- Patients not recovered to Grade 1 or stabilized from the adverse effects (excluding alopecia) of any prior therapy for their malignancies
- Women who are pregnant or lactating
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: ONO-4685 monotherapy
Patients with relapsed or refractory T cell Lymphoma who meet eligibility criteria will be enrolled to receive ONO-4685 monotherapy |
ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence, nature, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs).
Tidsramme: Through study completion, an average of 1 year
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Adverse events with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 used as a guide for the grading of severity. |
Through study completion, an average of 1 year
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Estimate of Maximum Tolerate Dose (MTD)
Tidsramme: Up to 3 weeks
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MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment |
Up to 3 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Plasma Concentration of ONO-4685
Tidsramme: Up to 48 weeks
|
Plasma concentration will be assessed to evaluate Pharmacokinetics |
Up to 48 weeks
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Plasma Concentration of Anti-Drug Antibody (ADA)
Tidsramme: Up to 48 weeks
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ADA to ONO-4685 will be assessed to evaluate potential immunogenicity. |
Up to 48 weeks
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Antitumor Activity of ONO-4685
Tidsramme: Through study completion, an average of 1 year
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Antitumor Activity of ONO-4685 will be assessed according to the response criteria for Lymphoma. |
Through study completion, an average of 1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Project Leader, Ono Pharmaceutical Co., Ltd.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Neoplasmer
- Sygdomsegenskaber
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Lymfesygdomme
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom
- Patologiske tilstande, tegn og symptomer
- Hemiske og lymfatiske sygdomme
- Tilbagevenden
- Lymfom, T-celle
Andre undersøgelses-id-numre
- ONO-4685-03
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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