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

Primary Purpose

Assess the Efficacy and Safety of SyB L-0501 in Combination With Rituximab in Patients With Recurrent or Relapsed DLBCL

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Rituximab
Sponsored by
SymBio Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Assess the Efficacy and Safety of SyB L-0501 in Combination With Rituximab in Patients With Recurrent or Relapsed DLBCL focused on measuring Diffuse large B-cell lymphoma, rituximab, SyB L-0501, combination therapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SyB L-0501

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall Response Rate
Complete Response (CR) + Partial Response (PR) Determined on the Basis of Revised Response Criteria for Malignant Lymphoma (Revised RC 2007)

Secondary Outcome Measures

Complete Response (CR) Rate
Determined on the Basis of Revised Response Criteria for Malignant Lymphoma (Revised RC 2007)
Progression Free Survival (PFS)
PFS = day of the first PFS event - day of start of study treatment + 1
Duration of Response (DOR)
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.
Overall Survival (OS)
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.

Full Information

First Posted
December 10, 2017
Last Updated
April 13, 2023
Sponsor
SymBio Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03372837
Brief Title
Phase III Study of SyB L-0501 in Combination With Rituximab to Treat Recurrent/Relapsed Diffuse Large B-Cell Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SymBio Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Assess the Efficacy and Safety of SyB L-0501 in Combination With Rituximab in Patients With Recurrent or Relapsed DLBCL
Keywords
Diffuse large B-cell lymphoma, rituximab, SyB L-0501, combination therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SyB L-0501
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
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 Measure Information:
Title
Overall Response Rate
Description
Complete Response (CR) + Partial Response (PR) Determined on the Basis of Revised Response Criteria for Malignant Lymphoma (Revised RC 2007)
Time Frame
up to 30 weeks
Secondary Outcome Measure Information:
Title
Complete Response (CR) Rate
Description
Determined on the Basis of Revised Response Criteria for Malignant Lymphoma (Revised RC 2007)
Time Frame
up to 30 weeks
Title
Progression Free Survival (PFS)
Description
PFS = day of the first PFS event - day of start of study treatment + 1
Time Frame
up to 30 weeks
Title
Duration of Response (DOR)
Description
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.
Time Frame
up to 30 weeks
Title
Overall Survival (OS)
Description
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.
Time Frame
up to 30 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Patients who satisfy all of the conditions listed below. 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). Patients with documented Cluster of differentiation 20 (CD20)-positive for lymphoma cells. Patient with recurrent or relapsed DLBCL after R-CHOP-like theraphy as the firstline therapy. Patients with measurable lesions >1.5 cm in major axes. Patients who are expected to survive for at least 3 months. Patients aged 20 or above at the time informed consent is obtained. Patient with Performance Status (P.S.) 0-1. Patients with adequately maintained organ function. Exclusion Criteria The study subject should be excluded if any one of the following condition exists. 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. Patient who received prior chemotherapy 3 regimens or more. Patients with central nervous system (CNS) involvement or patients with clinical symptoms suggestive of CNS involvement. Patient with serious active infection. Patient with serious complication. Patient with complication or medical history of serious cardiac disease. Patient with serious gastrointestinal symptoms. Patient with malignant pleural effusion, pericardial effusion, or ascites retention. Patients positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, or HIV antibody. Patient with serious bleeding tendency. Patient 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. Patient who received bendamustin hydrochloride 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.
Facility Information:
Facility Name
Research Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Toyoake
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Matsuyama
State/Province
Ehime
Country
Japan
Facility Name
Research Site
City
Maebashi
State/Province
Gunma
Country
Japan
Facility Name
Research Site
City
Shibukawa
State/Province
Gunma
Country
Japan
Facility Name
Research Site
City
Ōta
State/Province
Gunma
Country
Japan
Facility Name
Research Site
City
Fukuyama
State/Province
Hiroshima
Country
Japan
Facility Name
Research Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Isehara
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Research Site
City
Osakasayama
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Izumo
State/Province
Shimane
Country
Japan
Facility Name
Research Site
City
Mibu
State/Province
Tochigi
Country
Japan
Facility Name
Research Site
City
Shimotsuke
State/Province
Tochigi
Country
Japan
Facility Name
Research Site
City
Chuo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Koto-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Shibuya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Akita
Country
Japan
Facility Name
Research Site
City
Fukuoka
Country
Japan
Facility Name
Research Site
City
Fukushima
Country
Japan
Facility Name
Research Site
City
Ibaraki
Country
Japan
Facility Name
Research Site
City
Kumamoto
Country
Japan
Facility Name
Research Site
City
Kyoto
Country
Japan
Facility Name
Research Site
City
Nagasaki
Country
Japan
Facility Name
Research Site
City
Okayama
Country
Japan
Facility Name
Research Site
City
Osaka
Country
Japan
Facility Name
Research Site
City
Yamagata
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35244756
Citation
Murayama K, Kiguchi T, Izutsu K, Kameoka Y, Hidaka M, Kato H, Rai S, Kuroda J, Ishizawa K, Ichikawa S, Ando K, Ogura M, Fukushima K, Terui Y. Bendamustine plus rituximab in Japanese patients with relapsed or refractory diffuse large B-cell lymphoma. Ann Hematol. 2022 May;101(5):979-989. doi: 10.1007/s00277-022-04801-2. Epub 2022 Mar 4.
Results Reference
derived

Learn more about this trial

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

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