Phase I/II Study of SyB L-0501RI in Combination With Rituximab to Treat Lymphoma

A Multicenter, Open-label, Phase I/II Study to Investigate the Safety and Tolerability of SyB L-0501RI (Bendamustine Hydrochloride for Injection) Administered As an Intravenous (IV) Rapid Infusion Over 10 Minutes

NCT03900377•SymBio Pharmaceuticals

View on ClinicalTrials.gov

Summary

For SyB L-0501RI administered by an intravenous rapid infusion in combination with rituximab, the safety will be investigated in previously untreated patients with low-grade B-cell non-Hodgkin's lymphoma (Lg-B-NHL) or mantle cell lymphoma (MCL), and the safety and tolerability will be investigated in patients with recurrent/refractory diffuse large B-cell lymphoma (DLBCL).

Eligibility

Age

20 - 79 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For previously untreated patients with Lg-B-NHL or MCL
•Patients who satisfy all of the conditions listed below:
•▪ Patients who satisfy all of the following criteria A) to D): A) Patients who are histopathologically confirmed to have one of the following subtypes of CD20 (cluster of differentiation 20)-positive Lg-B-NHL or MCL (excluding transformed lymphoma) by lymph node biopsy or evaluable tissue biopsy (World Health Organization \[WHO\] histological classification \[4th edition\]).
•Small lymphocytic lymphoma
•Splenic marginal zone lymphoma
•Lymphoplasmacytic lymphoma
•Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT)
•Nodal marginal zone lymphoma
•Follicular lymphoma (Grade 1, 2, 3a)
•MCL B) Patients who have at least one measurable lesion (\>1.5 cm in major axis on computed tomography \[CT\]).
+42 more criteria

Exclusion Criteria

•Patients who meet any of the following conditions will be excluded:
•MCL patients aged ≤65 years (at the time of registration).
•Patients who have a history of treatment for Lg-B-NHL or MCL (chemotherapy, radiotherapy, antibody therapy or antitumor steroid therapy).
•Patients who have previously received hematopoietic stem cell transplantation.
•Patients with invasion to central nervous system (CNS) or clinical symptoms suspected of CNS invasion.
•Patients with serious active infection (requiring antibiotic, antifungal, or antiviral IV injection).
•Patients with serious complications (such as hepatic failure and renal failure).
•Patients with concurrent or previous, serious cardiac disease (e.g., myocardial infarction, ischemic heart disease); however, patients with arrhythmias are allowed to be enrolled if it does not require treatment at the time of registration.
•Patients with serious gastrointestinal symptoms (such as high-grade or severe nausea/vomiting or diarrhea).
•Patients with malignant pleural effusion, pericardial effusion, or ascites.
+48 more criteria

Locations (14)

Research Site

Nagoya, Aichi-ken, Japan

Research Site

Ōta, Gunma, Japan

Research Site

Sapporo, Hokkaido, Japan

Research Site

Kobe, Hyōgo, Japan

Research Site

Isehara, Kanagawa, Japan

Research Site

Kurashiki, Okayama-ken, Japan

Research Site

Koto-ku, Tokyo, Japan

Research Site

Akita, Japan

Research Site

Fukuoka, Japan

Research Site

Kagoshima, Japan

Key Dates

Start Date

April 1, 2019

Primary Completion Date

September 9, 2020

Completion Date

February 26, 2021

Last Updated

November 24, 2023

Enrollment

ACTUAL participants

Conditions

Lymphoma, B-cell, Diffuse

Interventions

SyB L-0501RI

DRUG