- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01118845
Study of SyB L-0501 in Combination With Rituximab to Treat Relapsed/Refractory Diffuse Large B-Cell Lymphoma
A Multinational, Multicenter, Open-Label Phase II Study of SyB L-0501 in Combination With Rituximab in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Akita, Japan
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Fukuoka, Japan
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Kagoshima, Japan
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Kyoto, Japan
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Aichi
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Nagoya, Aichi, Japan
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Ehime
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Matsuyama, Ehime, Japan
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Fukuoka
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Kurume, Fukuoka, Japan
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Gunma
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Maebashi, Gunma, Japan
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Hokkaido
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Sapporo, Hokkaido, Japan
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Ishikawa
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Kanazawa, Ishikawa, Japan
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Kanagawa
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Isehara, Kanagawa, Japan
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Kumamoto
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Ninomaru, Kumamoto, Japan
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Miyagi
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Sendai, Miyagi, Japan
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Okayama
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Kita-ku, Okayama, Japan
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Kurashiki, Okayama, Japan
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Saitama
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Hidaka, Saitama, Japan
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Shimane
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Izumo, Shimane, Japan
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Tokyo
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Chuo-ku, Tokyo, Japan
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Busan
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Seo-gu, Busan, Korea, Republikken
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Daegu
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Jung-gu, Daegu, Korea, Republikken
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Korea, Republikken
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Jeonnam
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Hwasun-gun, Jeonnam, Korea, Republikken
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Seoul
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Gangnam-gu, Seoul, Korea, Republikken
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Seodaemun-gu, Seoul, Korea, Republikken
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Songpa-gu, Seoul, Korea, Republikken
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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:
- Patients with documented Cluster of differentiation 20 (CD20)-positive for lymphoma cells
- Patients with measurable lesions
- Patients with measurable lesions >1.5 cm in major axes
- Relapsed or refractory after 1 to 3 prior therapeutic treatments for diffuse large B-cell lymphoma.
- Patients who are expected to survive for at least 3 months
- Patients aged from 20 to 75 years at the time informed consent is obtained
- Performance Status (P.S.) of 0 to 1 at initial administration of the study drug
- Patients with adequately maintained organ functions
- Patients capable of personally giving voluntary informed consent in writing to participate in the study
Exclusion Criteria:
- Patients who have been without treatment for less than 3 weeks after prior treatment
- Patients who can be candidates for autologous peripheral blood stem cell transplantation at the discretion of the investigator.
- Patients who received adequate prior treatments and did not respond to any of them.
- Patients with central nervous system (CNS) involvement or patients with clinical symptoms suggestive of CNS involvement.
- Patients with serious, active infections
- Patients with serious complications
- Patients with complications or medical history of serious cardiac disease
- Patients with serious gastrointestinal symptoms
- Patients with malignant pleural effusion, cardiac effusion, or ascites retention
- Patients positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, or HIV antibody
- Patients with serious bleeding tendencies
- Patients with a fever of 38.0°C or higher
- Patients with, or confirmed in the past to have had, interstitial pneumonia, pulmonary fibrosis, or pulmonary emphysema
- Patients with active multiple primary cancer or patients with a history of other malignant cancer within the past 5 years, except for basal cell cancer of the skin, squamous cell cancer, or cervical cancer in situ
- Patients with, or confirmed in the past to have had, autoimmune hemolytic anemia
- Patients who received SyB L-0501 in the past
- Patients who received cytokine preparation such as erythropoietin or granulocyte colony-stimulating factor (G-CSF) or blood transfusions within 2 weeks before the examination at registration for this study
- Patients who received other investigational products or unapproved medication within 3 months before registration in this study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: SyB L-0501
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The administration of SyB L-0501 at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. SyB L-0501 60 mg/m^2, 90 mg/m^2 or 120 mg/m^2/day on Day 2 and Day 3 will be followed by 18 days of observation.
Andre navne:
The administration of rituximab at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles.
Dose modifications are not permitted.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
Tidsramme: up to 30 weeks
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CR: Disappearance of all evidence of disease. PR: Regression of measurable disease and no new sites. For the criteria for CR, See Outcome measure 2 description. The criteria for PR is as below. Nodal Masses: more than 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes
Spleen, Liver: more than 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified |
up to 30 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
Tidsramme: up to 30 weeks
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The criteria for CR is as below Nodal Masses:
Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative |
up to 30 weeks
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Progression Free Survival (PFS)
Tidsramme: up to 30 weeks
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PFS = day of the first PFS event - day of start of study treatment + 1 The definitions of PFS event are as below.
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up to 30 weeks
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Number of Subjects With Adverse Event
Tidsramme: up to 30 weeks
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up to 30 weeks
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Number of Adverse Events
Tidsramme: up to 30 weeks
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up to 30 weeks
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Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
Tidsramme: up to 30 weeks
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Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild grade 2 : moderate grade 3 : severe grade 4 : life threatening or disabling grade 5 : death related to adverse event |
up to 30 weeks
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Number of Subjects With Grade ≥3 Physical Examination Finding
Tidsramme: up to 30 weeks
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up to 30 weeks
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Concomitant Medication Usage
Tidsramme: up to 30 weeks
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up to 30 weeks
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The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan
Tidsramme: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Japan
Tidsramme: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Japan
Tidsramme: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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The Half-life Period (t1/2) of Unchanged SyB L-0501 in Japan
Tidsramme: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Korea
Tidsramme: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Korea
Tidsramme: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Korea
Tidsramme: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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The Half-life Period (t1/2) of Unchanged SyB L-0501 in Korea
Tidsramme: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Lymfom, B-celle
- Lymfom
- Lymfom, stor B-celle, diffus
- Lymfom, Non-Hodgkin
- Lymfom, kappecelle
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antirheumatiske midler
- Antineoplastiske midler
- Immunologiske faktorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Antineoplastiske midler, immunologiske
- Bendamustine hydrochlorid
- Rituximab
Andre undersøgelses-id-numre
- 2010001
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Kliniske forsøg med Follikulært lymfom
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National Cancer Institute (NCI)Celgene CorporationAktiv, ikke rekrutterendeAnn Arbor trin III grad 1 follikulært lymfom | Ann Arbor trin III grad 2 follikulært lymfom | Ann Arbor Stage IV Grad 1 follikulært lymfom | Ann Arbor trin IV grad 2 follikulært lymfom | Ann Arbor Stage II Grade 3 Contiguous Follicular Lymfom | Ann Arbor Stage II Grade 3 Non-Contiguous Follikulær... og andre forholdForenede Stater
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National Cancer Institute (NCI)AfsluttetAnn Arbor trin III grad 1 follikulært lymfom | Ann Arbor trin III grad 2 follikulært lymfom | Ann Arbor Stage IV Grad 1 follikulært lymfom | Ann Arbor trin IV grad 2 follikulært lymfom | Ann Arbor Stage II Grade 3 Contiguous Follicular Lymfom | Ann Arbor Stage II Grade 3 Non-Contiguous Follikulær... og andre forholdForenede Stater
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Portola PharmaceuticalsTrukket tilbageAITL | Perifert T-celle lymfom (PTCL NOS) | Nodale lymfomer af T Follicular Helper (TFH) | Follikulært T-celle lymfom (FTCL) | ALCL | HSTCL | EATL I,II | MEITL, EATL Type II | Nasal lymfom
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Mayo ClinicNational Cancer Institute (NCI)AfsluttetAnn Arbor Stage I Grade 1 Follikulært lymfom | Ann Arbor Stage I Grade 2 Follikulært lymfom | Ann Arbor trin III grad 1 follikulært lymfom | Ann Arbor trin III grad 2 follikulært lymfom | Ann Arbor Stage IV Grad 1 follikulært lymfom | Ann Arbor trin IV grad 2 follikulært lymfom | Ann Arbor Stage II... og andre forholdForenede Stater
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National Cancer Institute (NCI)AfsluttetHIV-infektion | Tilbagevendende grad 3 follikulært lymfom | Plasmablastisk lymfom | Tilbagevendende diffust stort B-cellet lymfom | Primært effusionslymfom | AIDS-relateret primært effusionslymfom | Ann Arbor Stage I diffust stort B-cellet lymfom | Ann Arbor Stage II diffust stort B-cellet lymfom | Ann... og andre forholdForenede Stater
Kliniske forsøg med SyB L-0501
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SymBio PharmaceuticalsAfsluttetKronisk lymfatisk leukæmiJapan
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SymBio PharmaceuticalsAfsluttetRecidiverende/Refraktær MyelomJapan
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SymBio PharmaceuticalsAfsluttetLavgradigt B-celle non-Hodgkins lymfom | Mantelcellelymfom, hvor hæmatopoietisk stamcelletransplantation ikke er indiceretJapan
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University of WashingtonNational Cancer Institute (NCI); National Comprehensive Cancer NetworkAfsluttetAnaplastisk astrocytom hos voksne | Voksen Anaplastisk Oligodendrogliom | Voksen kæmpecelleglioblastom | Voksen glioblastom | Gliosarkom hos voksne | Tilbagevendende voksen hjerneneoplasmaForenede Stater
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SymBio PharmaceuticalsAfsluttet
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SymBio PharmaceuticalsAfsluttet
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SymBio PharmaceuticalsAfsluttet
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SymBio PharmaceuticalsAfsluttetFollikulært lymfom | Diffust storcellet B-celle lymfom | Non-Hodgkins lymfom | MantelcellelymfomJapan
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SymBio PharmaceuticalsAfsluttetAvanceret solid tumorJapan
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Boehringer IngelheimAfsluttet