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

29. mai 2013 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

63

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Japan
      • 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
  • Korea, Republikken
    • Busan
      • Seo-gu, Busan, Korea, Republikken
    • Daegu
      • Jung-gu, Daegu, Korea, Republikken
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republikken
    • Jeonnam
      • Hwasun-gun, Jeonnam, Korea, Republikken
    • Seoul
      • Gangnam-gu, Seoul, Korea, Republikken
      • Seodaemun-gu, Seoul, Korea, Republikken
      • Songpa-gu, Seoul, Korea, Republikken

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: SyB L-0501
Legemiddel: 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.

Andre navn:
  • Bendamustinhydroklorid
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
Tidsramme: 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)
Tidsramme: 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
Tidsramme: up to 30 weeks
up to 30 weeks
Number of Adverse Events
Tidsramme: up to 30 weeks
up to 30 weeks
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
Tidsramme: 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
Tidsramme: up to 30 weeks
up to 30 weeks
Concomitant Medication Usage
Tidsramme: up to 30 weeks
up to 30 weeks
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

SymBio Pharmaceuticals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2010

Primær fullføring (Faktiske)

1. oktober 2011

Studiet fullført (Faktiske)

1. oktober 2011

Datoer for studieregistrering

Først innsendt

1. mai 2010

Først innsendt som oppfylte QC-kriteriene

6. mai 2010

Først lagt ut (Anslag)

7. mai 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

4. juli 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mai 2013

Sist bekreftet

1. mai 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2010001

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