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

29 mei 2013 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

63

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: SyB L-0501
Geneesmiddel: 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:
  • Bendamustine hydrochloride
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: up to 30 weeks
up to 30 weeks
Number of Adverse Events
Tijdsspanne: up to 30 weeks
up to 30 weeks
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
Tijdsspanne: 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
Tijdsspanne: up to 30 weeks
up to 30 weeks
Concomitant Medication Usage
Tijdsspanne: up to 30 weeks
up to 30 weeks
The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

SymBio Pharmaceuticals

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2010

Primaire voltooiing (Werkelijk)

1 oktober 2011

Studie voltooiing (Werkelijk)

1 oktober 2011

Studieregistratiedata

Eerst ingediend

1 mei 2010

Eerst ingediend dat voldeed aan de QC-criteria

6 mei 2010

Eerst geplaatst (Schatting)

7 mei 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

4 juli 2013

Laatste update ingediend die voldeed aan QC-criteria

29 mei 2013

Laatst geverifieerd

1 mei 2013

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2010001

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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