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Study of SyB L-0501 in Combination With Rituximab to Treat Relapsed/Refractory Diffuse Large B-Cell Lymphoma

29 maggio 2013 aggiornato da: SymBio Pharmaceuticals

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

The purpose of this study is to determine the efficacy of SyB L-0501 in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Primary Objective is to determine the efficacy, as measured by overall response rate on the basis of Revised Response Criteria for Malignant Lymphoma, of SyB L-0501 at 120 mg/m^2/day on day2 and 3 in combination with rituximab at 375 mg/m^2 on day 1 of each 21-day cycle in patients with relapsed/refractory diffuse large B-cell lymphoma.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

63

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Corea, Repubblica di
    • Busan
      • Seo-gu, Busan, Corea, Repubblica di
    • Daegu
      • Jung-gu, Daegu, Corea, Repubblica di
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Corea, Repubblica di
    • Jeonnam
      • Hwasun-gun, Jeonnam, Corea, Repubblica di
    • Seoul
      • Gangnam-gu, Seoul, Corea, Repubblica di
      • Seodaemun-gu, Seoul, Corea, Repubblica di
      • Songpa-gu, Seoul, Corea, Repubblica di
  • Giappone
      • Akita, Giappone
      • Fukuoka, Giappone
      • Kagoshima, Giappone
      • Kyoto, Giappone
    • Aichi
      • Nagoya, Aichi, Giappone
    • Ehime
      • Matsuyama, Ehime, Giappone
    • Fukuoka
      • Kurume, Fukuoka, Giappone
    • Gunma
      • Maebashi, Gunma, Giappone
    • Hokkaido
      • Sapporo, Hokkaido, Giappone
    • Ishikawa
      • Kanazawa, Ishikawa, Giappone
    • Kanagawa
      • Isehara, Kanagawa, Giappone
    • Kumamoto
      • Ninomaru, Kumamoto, Giappone
    • Miyagi
      • Sendai, Miyagi, Giappone
    • Okayama
      • Kita-ku, Okayama, Giappone
      • Kurashiki, Okayama, Giappone
    • Saitama
      • Hidaka, Saitama, Giappone
    • Shimane
      • Izumo, Shimane, Giappone
    • Tokyo
      • Chuo-ku, Tokyo, Giappone

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 20 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: SyB L-0501
Droga: 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.

Altri nomi:
  • Bendamustina cloridrato
Droga: Rituximab
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
Lasso di tempo: 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

  1. FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site
  2. Variably FDG-avid or PET negative; regression on CT

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
Lasso di tempo: up to 30 weeks

The criteria for CR is as below

Nodal Masses:

  1. fluorodeoxy glucose (FDG)-avid or positron emission tomography (PET) positive prior to therapy; mass of any size permitted if PET negative
  2. Variably FDG-avid or PET negative; regression to normal size on computed tomography (CT)

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)
Lasso di tempo: 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.

  1. PD according to overall response on the basis of Revised Response Criteria for Malignant Lymphoma

    PD: Any new lesion or increase by ≥50% of previously involved sites from nadir. Nodal masses; Appearance of a new lesion(s) >1.5 cm in any axis, ≥50% increase in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node >1 cm in short axis. Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. Spleen, Liver; ≥50% increase from nadir in the SPD of any previous lesions. Bone marrow; New or recurrent involvement

  2. Disease progression during treatment period
  3. Disease progression during follow up period
  4. Start of treatment of new lesion
  5. Occurrence of other multiple malignant tumors
  6. Death
up to 30 weeks
Number of Subjects With Adverse Event
Lasso di tempo: up to 30 weeks
up to 30 weeks
Number of Adverse Events
Lasso di tempo: up to 30 weeks
up to 30 weeks
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
Lasso di tempo: 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
Lasso di tempo: up to 30 weeks
up to 30 weeks
Concomitant Medication Usage
Lasso di tempo: up to 30 weeks
up to 30 weeks
The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

SymBio Pharmaceuticals

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2010

Completamento primario (Effettivo)

1 ottobre 2011

Completamento dello studio (Effettivo)

1 ottobre 2011

Date di iscrizione allo studio

Primo inviato

1 maggio 2010

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2010

Primo Inserito (Stima)

7 maggio 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

4 luglio 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 maggio 2013

Ultimo verificato

1 maggio 2013

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2010001

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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