- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
-
Akita, Japan
-
Fukuoka, Japan
-
Kagoshima, Japan
-
Kyoto, Japan
-
-
Aichi
-
Nagoya, Aichi, Japan
-
-
Ehime
-
Matsuyama, Ehime, Japan
-
-
Fukuoka
-
Kurume, Fukuoka, Japan
-
-
Gunma
-
Maebashi, Gunma, Japan
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan
-
-
Ishikawa
-
Kanazawa, Ishikawa, Japan
-
-
Kanagawa
-
Isehara, Kanagawa, Japan
-
-
Kumamoto
-
Ninomaru, Kumamoto, Japan
-
-
Miyagi
-
Sendai, Miyagi, Japan
-
-
Okayama
-
Kita-ku, Okayama, Japan
-
Kurashiki, Okayama, Japan
-
-
Saitama
-
Hidaka, Saitama, Japan
-
-
Shimane
-
Izumo, Shimane, Japan
-
-
Tokyo
-
Chuo-ku, Tokyo, Japan
-
-
-
-
Busan
-
Seo-gu, Busan, Korea, Republik von
-
-
Daegu
-
Jung-gu, Daegu, Korea, Republik von
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Korea, Republik von
-
-
Jeonnam
-
Hwasun-gun, Jeonnam, Korea, Republik von
-
-
Seoul
-
Gangnam-gu, Seoul, Korea, Republik von
-
Seodaemun-gu, Seoul, Korea, Republik von
-
Songpa-gu, Seoul, Korea, Republik von
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: SyB L-0501
|
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.
Andere Namen:
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
Zeitfenster: up to 30 weeks
|
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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
Zeitfenster: up to 30 weeks
|
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
|
Progression Free Survival (PFS)
Zeitfenster: up to 30 weeks
|
PFS = day of the first PFS event - day of start of study treatment + 1 The definitions of PFS event are as below.
|
up to 30 weeks
|
Number of Subjects With Adverse Event
Zeitfenster: up to 30 weeks
|
up to 30 weeks
|
|
Number of Adverse Events
Zeitfenster: up to 30 weeks
|
up to 30 weeks
|
|
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
Zeitfenster: up to 30 weeks
|
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
|
Number of Subjects With Grade ≥3 Physical Examination Finding
Zeitfenster: up to 30 weeks
|
up to 30 weeks
|
|
Concomitant Medication Usage
Zeitfenster: up to 30 weeks
|
up to 30 weeks
|
|
The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan
Zeitfenster: 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
|
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
|
|
The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Japan
Zeitfenster: 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
|
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
|
|
The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Japan
Zeitfenster: 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
|
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
|
|
The Half-life Period (t1/2) of Unchanged SyB L-0501 in Japan
Zeitfenster: 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
|
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
|
|
The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Korea
Zeitfenster: 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
|
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
|
|
The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Korea
Zeitfenster: 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
|
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
|
|
The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Korea
Zeitfenster: 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
|
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
|
|
The Half-life Period (t1/2) of Unchanged SyB L-0501 in Korea
Zeitfenster: 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
|
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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Immunsystems
- Neubildungen nach histologischem Typ
- Neubildungen
- Lymphoproliferative Erkrankungen
- Lymphatische Erkrankungen
- Immunproliferative Erkrankungen
- Lymphom, B-Zell
- Lymphom
- Lymphom, große B-Zelle, diffus
- Lymphom, Non-Hodgkin
- Lymphom, Mantelzelle
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antirheumatika
- Antineoplastische Mittel
- Immunologische Faktoren
- Antineoplastische Mittel, alkylierend
- Alkylierungsmittel
- Antineoplastische Mittel, immunologische
- Bendamustinhydrochlorid
- Rituximab
Andere Studien-ID-Nummern
- 2010001
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Follikuläres Lymphom
-
SWOG Cancer Research NetworkNational Cancer Institute (NCI); Genentech, Inc.RekrutierungDiffuses großzelliges B-Zell-Lymphom | Wiederkehrendes diffuses großzelliges B-Zell-Lymphom | Refraktäres diffuses großzelliges B-Zell-Lymphom | Primäres mediastinales (thymisches) großes B-Zell-Lymphom | Follikuläres Lymphom Grad 3b | Transformierte follikuläre Lymphe zu Diff Large B-Zell-Lymphom und andere BedingungenVereinigte Staaten
Klinische Studien zur SyB L-0501
-
SymBio PharmaceuticalsAbgeschlossenChronischer lymphatischer LeukämieJapan
-
SymBio PharmaceuticalsAbgeschlossenRezidiviertes/refraktäres multiples MyelomJapan
-
SymBio PharmaceuticalsAbgeschlossenLow-grade-B-Zell-Non-Hodgkin-Lymphom | Mantelzell-Lymphom, bei dem eine Transplantation hämatopoetischer Stammzellen nicht indiziert istJapan
-
University of WashingtonNational Cancer Institute (NCI); National Comprehensive Cancer NetworkAbgeschlossenAnaplastisches Astrozytom des Erwachsenen | Erwachsenes anaplastisches Oligodendrogliom | Adultes Riesenzell-Glioblastom | Erwachsenes Glioblastom | Erwachsenes Gliosarkom | Rezidivierende Hirntumoren bei ErwachsenenVereinigte Staaten
-
SymBio PharmaceuticalsAbgeschlossen
-
SymBio PharmaceuticalsBeendetMultiples MyelomJapan
-
SymBio PharmaceuticalsAbgeschlossen
-
SymBio PharmaceuticalsAbgeschlossenFollikuläres Lymphom | Diffuses großzelliges B-Zell-Lymphom | Non-Hodgkin-Lymphom | Mantelzell-LymphomJapan
-
SymBio PharmaceuticalsAbgeschlossenFortgeschrittener solider TumorJapan
-
Boehringer IngelheimAbgeschlossen