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

April 13, 2023 updated by: SymBio Pharmaceuticals

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • 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
        • Research Site
    • Aichi
      • Nagoya, Aichi, Japan
        • Research Site
      • Toyoake, Aichi, Japan
        • Research Site
    • Ehime
      • Matsuyama, Ehime, Japan
        • Research Site
    • Gunma
      • Maebashi, Gunma, Japan
        • Research Site
      • Shibukawa, Gunma, Japan
        • Research Site
      • Ōta, Gunma, Japan
        • Research Site
    • Hiroshima
      • Fukuyama, Hiroshima, Japan
        • Research Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Research Site
    • Hyogo
      • Kobe, Hyogo, Japan
        • Research Site
    • Kanagawa
      • Isehara, Kanagawa, Japan
        • Research Site
    • Miyagi
      • Sendai, Miyagi, Japan
        • Research Site
    • Osaka
      • Osakasayama, Osaka, Japan
        • Research Site
    • Shimane
      • Izumo, Shimane, Japan
        • Research Site
    • Tochigi
      • Mibu, Tochigi, Japan
        • Research Site
      • Shimotsuke, Tochigi, Japan
        • Research Site
    • Tokyo
      • Chuo-ku, Tokyo, Japan
        • Research Site
      • Koto-ku, Tokyo, Japan
        • Research Site
      • Shibuya-ku, Tokyo, Japan
        • Research Site
      • Shinagawa-ku, Tokyo, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 30 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response (CR) Rate
Time Frame: up to 30 weeks
Determined on the Basis of Revised Response Criteria for Malignant Lymphoma (Revised RC 2007)
up to 30 weeks
Progression Free Survival (PFS)
Time Frame: up to 30 weeks
PFS = day of the first PFS event - day of start of study treatment + 1
up to 30 weeks
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.
up to 30 weeks
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.
up to 30 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

December 10, 2017

First Submitted That Met QC Criteria

December 10, 2017

First Posted (Actual)

December 14, 2017

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 13, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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