NCT03372837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 18, 2023

Status Verified

June 1, 2022

Enrollment Period

2 years

First QC Date

December 10, 2017

Last Update Submit

April 13, 2023

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate

    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 Outcomes (4)

  • Complete Response (CR) Rate

    up to 30 weeks

  • Progression Free Survival (PFS)

    up to 30 weeks

  • Duration of Response (DOR)

    up to 30 weeks

  • Overall Survival (OS)

    up to 30 weeks.

Study Arms (1)

SyB L-0501

EXPERIMENTAL

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

Interventions

RituximabDRUG

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.

SyB L-0501

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Research Site

Nagoya, Aichi-ken, Japan

Location

Research Site

Toyoake, Aichi-ken, Japan

Location

Research Site

Matsuyama, Ehime, Japan

Location

Research Site

Maebashi, Gunma, Japan

Location

Research Site

Ōta, Gunma, Japan

Location

Research Site

Shibukawa, Gunma, Japan

Location

Research Site

Fukuyama, Hiroshima, Japan

Location

Research Site

Sapporo, Hokkaido, Japan

Location

Research Site

Kobe, Hyōgo, Japan

Location

Research Site

Isehara, Kanagawa, Japan

Location

Research Site

Sendai, Miyagi, Japan

Location

Research Site

Sayama, Osaka, Japan

Location

Research Site

Izumo, Shimane, Japan

Location

Research Site

Mibu, Tochigi, Japan

Location

Research Site

Shimotsuke, Tochigi, Japan

Location

Research Site

Chuo-ku, Tokyo, Japan

Location

Research Site

Koto-ku, Tokyo, Japan

Location

Research Site

Shibuya-ku, Tokyo, Japan

Location

Research Site

Shinagawa-ku, Tokyo, Japan

Location

Research Site

Akita, Japan

Location

Research Site

Fukuoka, Japan

Location

Research Site

Fukushima, Japan

Location

Research Site

Ibaraki, Japan

Location

Research Site

Kumamoto, Japan

Location

Research Site

Kyoto, Japan

Location

Research Site

Nagasaki, Japan

Location

Research Site

Okayama, Japan

Location

Research Site

Osaka, Japan

Location

Research Site

Yamagata, Japan

Location

Related Publications (1)

  • 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.

    PMID: 35244756DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2017

First Posted

December 14, 2017

Study Start

January 15, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 18, 2023

Record last verified: 2022-06

Locations

JP(29)