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

NCT03900377 | Completed Phase 1 DMC

• 1 other identifier: 2018001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 14

Brief 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).

Conditions

Lymphoma, B-cell, Diffuse

Keywords

Lymphoma, B-cell, Diffuse, SyB L-0501RI

Outcome Measures

Primary Outcomes (6)

• Adverse events (type, frequency, severity)

  Up to 36 weeks

• Number of subjects with adverse event

  Up to 36 weeks

• Number of adverse events

  Up to 36 weeks

• Number of subjects with abnormality (Common Terminology Criteria for Adverse Events [CTCAE] grade ≥3) in laboratory test values

  Up to 36 weeks

• Number of subjects with grade ≥3 physical examination finding

  Up to 36 weeks

• Number of subjects with dose limiting toxicity in DLBCL arm

  Up to 36 weeks

Secondary Outcomes (7)

• Complete response (CR) rate

  Up to 36 weeks

• Overall response rate (antitumor effect : ≥ partial response [PR])

  Up to 36 weeks

• Progression-free survival (PFS)

  Up to 36 weeks

• The maximum concentration (Cmax) of unchanged SyB L-0501

  Prior to and 5, 10 min after start of administration, and 5, 15, 30, 60, 120, 240, 360 min after completion of administration on Day 1 of the 1st cycle in Lg-B-NHL or MCL Arm (in DLBCL Arm, Day 2 of the 1st cycle)

• The maximum drug concentration time (Tmax) of unchanged SyB L-0501

  Prior to and 5, 10 min after start of administration, and 5, 15, 30, 60, 120, 240, 360 min after completion of administration on Day 1 of the 1st cycle in Lg-B-NHL or MCL Arm (in DLBCL Arm, Day 2 of the 1st cycle)

Study Arms (2)

Lg-B-NHL or MCL

EXPERIMENTAL

For previously untreated patients with Lg-B-NHL or MCL, rituximab will be intravenously administered at 375 mg/m\^2 on Day 0 (the day before Day 1 only in Cycle 1), and SyB L-0501RI will be intravenously administered at 90 mg/m\^2/day on Day 1 and Day 2 of each 28-day cycle with up to 6 cycles.

Drug: SyB L-0501RI

DLBCL

EXPERIMENTAL

For patients with recurrent or refractory DLBCL, rituximab will be intravenously administered at 375 mg/m\^2 on Day 1, and SyB L-0501RI will be intravenously administered at 120 mg/m\^2/day on Day 2 and Day 3 of each 21-day cycle with up to 6 cycles.

Drug: SyB L-0501RI

Interventions

SyB L-0501RI DRUG

The specified dose of SyB L-0501RI and rituximab will be administered by intravenous rapid infusion over 10 minutes on specified days.

Also known as: Rituximab

DLBCL; Lg-B-NHL or MCL

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[CT\]).
• C) Patients without a history of treatment for lymphoma. D) Patients with at least one of the following clinical signs or symptoms (with the exception of MCL patients).
• Bulky disease \>7 cm in major axis on CT (excluding lesions in the spleen)
• B symptoms
• Unexplained fever exceeding 38.0ºC
• Night sweats
• Weight loss of more than 10% within 6 months before registration

You may not qualify if:

• 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.
• Patients positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody (patients with positive hepatitis B virus \[HBV\]-DNA quantitative test results if they are negative for HBs antigen and positive for HBs antibody or hepatitis B core \[HBc\] antibody).
• Patients with serious bleeding tendencies (such as disseminated intravascular coagulation \[DIC\]).
• Patients with a fever of 38.0ºC or higher (with the exception of fever developing as a B symptom).
• Patients with concurrent or previous interstitial pneumonia, pulmonary fibrosis, or chronic obstructive pulmonary disease.
• Patients with active multiple primary cancers or patients with a history of other malignancy within the past 5 years, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or digestive organs.

Sponsors & Collaborators

• SymBio Pharmaceuticals: lead

Study Sites (14)

Research Site

Nagoya, Aichi-ken, Japan

Location

Research Site

Ōta, Gunma, Japan

Location

Research Site

Sapporo, Hokkaido, Japan

Location

Research Site

Kobe, Hyōgo, Japan

Location

Research Site

Isehara, Kanagawa, Japan

Location

Research Site

Kurashiki, Okayama-ken, Japan

Location

Research Site

Koto-ku, Tokyo, Japan

Location

Research Site

Akita, Japan

Location

Research Site

Fukuoka, Japan

Location

Research Site

Kagoshima, Japan

Location

Research Site

Kumamoto, Japan

Location

Research Site

Kyoto, Japan

Location

Research Site

Okayama, Japan

Location

Research Site

Yamagata, Japan

Location

Related Publications (1)

• Ishizawa K, Yokoyama M, Kato H, Yamamoto K, Makita M, Ando K, Ueda Y, Tachikawa Y, Suehiro Y, Kurosawa M, Kameoka Y, Nagai H, Uoshima N, Ishikawa T, Hidaka M, Ito Y, Utsunomiya A, Fukushima K, Ogura M. A phase I/II study of 10-min dosing of bendamustine hydrochloride (rapid infusion formulation) in patients with previously untreated indolent B-cell non-Hodgkin lymphoma, mantle cell lymphoma, or relapsed/refractory diffuse large B-cell lymphoma in Japan. Cancer Chemother Pharmacol. 2022 Jul;90(1):83-95. doi: 10.1007/s00280-022-04442-2. Epub 2022 Jul 7.

  PMID: 35796785 DERIVED

MeSH Terms

Conditions

Lymphoma

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: April 3, 2019
• Study Start: April 1, 2019
• Primary Completion: September 9, 2020
• Study Completion: February 26, 2021
• Last Updated: November 24, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (14)