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

Phase 1

Completed

• Conditions: Lymphoma, B-cell, Diffuse
• Interventions: Drug: SyB L-0501RI

• Registration Number: NCT03900377
• Lead Sponsor: SymBio Pharmaceuticals

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-06
• Study Start: 2019-04-01
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-03
• Primary Completion: 2020-09-09
• Study Completion: 2021-02-26
• Status Verified: 2023-06
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lg-B-NHL or MCL	SyB L-0501RI	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.
DLBCL	SyB L-0501RI	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.

Primary Outcome Measures

Name	Time	Method
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
Adverse events (type, frequency, severity)	Up to 36 weeks
Number of subjects with dose limiting toxicity in DLBCL arm	Up to 36 weeks
Number of subjects with adverse event	Up to 36 weeks

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Up to 36 weeks
The half-life period (T1/2) 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)
Overall response rate (antitumor effect : ≥ partial response [PR])	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)
Complete response (CR) rate	Up to 36 weeks
The area under the curve (AUC) for 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)

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamagata, Japan