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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03372837
Recruitment Status : Active, not recruiting
First Posted : December 14, 2017
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
SymBio Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Assess the Efficacy and Safety of SyB L-0501 in Combination With Rituximab in Patients With Recurrent or Relapsed DLBCL Drug: Rituximab Phase 3

Detailed Description:
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 Day 2 and Day 3 in combination with rituximab at 375 mg/m^2 on Day 1 of each 21-day cycle in patients with recurrent/relapsed diffuse large B-cell lymphoma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Phase III Study of SyB L-0501 in Combination With Rituximab in Patients With Recurrent or Relapsed Diffuse Large B-Cell Lymphoma
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: SyB L-0501

The administration of SyB L-0501 at 120 mg/m^2/day by intravenous infusion on Day 2 and Day 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.

Drug: 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.




Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: up to 30 weeks ]
    Complete Response (CR) + Partial Response (PR) Determined on the Basis of Revised Response Criteria for Malignant Lymphoma (Revised RC 2007)


Secondary Outcome Measures :
  1. Complete Response (CR) Rate [ Time Frame: up to 30 weeks ]
    Determined on the Basis of Revised Response Criteria for Malignant Lymphoma (Revised RC 2007)

  2. Progression Free Survival (PFS) [ Time Frame: up to 30 weeks ]
    PFS = day of the first PFS event - day of start of study treatment + 1

  3. Duration of Response (DOR) [ Time Frame: up to 30 weeks ]
    DOR is the period from the date of achieving CR, or PR in the responders to the earliest onset date of any progression events calculated using the Kaplan-Meier estimator. The median and the 95% Confidence Interval (CI ) were calculated using Greenwood's formula.

  4. Overall Survival (OS) [ Time Frame: up to 30 weeks. ]
    Death due to any given cause was defined as an event. OS was calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood's formula.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria Patients who satisfy all of the conditions listed below.

  1. Patients with histopathologically confirmed diffuse large B-cell lymphoma (DLBCL) except for transformed lymphoma on the basis of World Health Organization (WHO) histological classification (4th ed., 2008).
  2. Patients with documented Cluster of differentiation 20 (CD20)-positive for lymphoma cells.
  3. Patient with recurrent or relapsed DLBCL after R-CHOP-like theraphy as the firstline therapy.
  4. Patients with measurable lesions >1.5 cm in major axes.
  5. Patients who are expected to survive for at least 3 months.
  6. Patients aged 20 or above at the time informed consent is obtained.
  7. Patient with Performance Status (P.S.) 0-1.
  8. Patients with adequately maintained organ function.

Exclusion Criteria The study subject should be excluded if any one of the following condition exists.

  1. Patients who have been without treatment for less than 3 weeks after prior treatment.
  2. Patients who can be candidates for autologous peripheral blood stem cell transplantation at the discretion of the investigator.
  3. Patients who received adequate prior treatments and did not respond to any of them.
  4. Patient who received prior chemotherapy 3 regimens or more.
  5. Patients with central nervous system (CNS) involvement or patients with clinical symptoms suggestive of CNS involvement.
  6. Patient with serious active infection.
  7. Patient with serious complication.
  8. Patient with complication or medical history of serious cardiac disease.
  9. Patient with serious gastrointestinal symptoms.
  10. Patient with malignant pleural effusion, pericardial effusion, or ascites retention.
  11. Patients positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, or HIV antibody.
  12. Patient with serious bleeding tendency.
  13. Patient with a fever of 38.0°C or higher.
  14. Patients with, or confirmed in the past to have had, interstitial pneumonia, pulmonary fibrosis, or pulmonary emphysema.
  15. 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.
  16. Patients with, or confirmed in the past to have had, autoimmune hemolytic anemia.
  17. Patient who received bendamustin hydrochloride in the past.
  18. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372837


Locations
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Japan
Research Site
Nagoya, Aichi, Japan
Research Site
Toyoake, Aichi, Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Maebashi, Gunma, Japan
Research Site
Shibukawa, Gunma, Japan
Research Site
Ōta, Gunma, Japan
Research Site
Fukuyama, Hiroshima, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Kobe, Hyogo, Japan
Research Site
Isehara, Kanagawa, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Osakasayama, Osaka, Japan
Research Site
Izumo, Shimane, Japan
Research Site
Mibu, Tochigi, Japan
Research Site
Shimotsuke, Tochigi, Japan
Research Site
Chuo-ku, Tokyo, Japan
Research Site
Koto-ku, Tokyo, Japan
Research Site
Shibuya-ku, Tokyo, Japan
Research Site
Shinagawa-ku, Tokyo, Japan
Research Site
Akita, Japan
Research Site
Fukuoka, Japan
Research Site
Fukushima, Japan
Research Site
Ibaraki, Japan
Research Site
Kumamoto, Japan
Research Site
Kyoto, Japan
Research Site
Nagasaki, Japan
Research Site
Okayama, Japan
Research Site
Osaka, Japan
Research Site
Yamagata, Japan
Sponsors and Collaborators
SymBio Pharmaceuticals

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Responsible Party: SymBio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03372837    
Other Study ID Numbers: 2017002
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SymBio Pharmaceuticals:
Diffuse large B-cell lymphoma, rituximab, SyB L-0501, combination therapy
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents