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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- SymBio Pharmaceuticals
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Number of adverse events
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Lg-B-NHL or MCL
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.
Intervention: SyB L-0501RI (Drug)
DLBCL
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.
Intervention: SyB L-0501RI (Drug)
Outcomes
Primary Outcomes
Number of adverse events
Time Frame: Up to 36 weeks
Number of subjects with abnormality (Common Terminology Criteria for Adverse Events [CTCAE] grade ≥3) in laboratory test values
Time Frame: Up to 36 weeks
Number of subjects with grade ≥3 physical examination finding
Time Frame: Up to 36 weeks
Adverse events (type, frequency, severity)
Time Frame: Up to 36 weeks
Number of subjects with dose limiting toxicity in DLBCL arm
Time Frame: Up to 36 weeks
Number of subjects with adverse event
Time Frame: Up to 36 weeks
Secondary Outcomes
- 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))