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Vincristine Sulfate Liposome Injection with Bendamustine and Rituximab as First-Line Therapy for B-Cell Lymphomas: A
Thomas Ollila1,2, James Butera1,2, Pamela Egan1,2
1Department of Medicine, Alpert Medical School of Brown University, Providence, RI, USA.
The Oncologist
|May 31, 2022
Summary
This Phase I trial combined vincristine sulfate liposomal injection with bendamustine and rituximab for lymphoma. The maximum tolerated dose was established, but toxicities and recurrences limited further development.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Investigator-initiated Phase I trial evaluating a novel drug combination for hematologic malignancies.
- Focus on indolent B-cell lymphoma (BCL) and mantle cell lymphoma (MCL).
Purpose of the Study:
- Determine the maximum tolerated dose (MTD) of vincristine sulfate liposomal injection (VSLI) when combined with bendamustine and rituximab (BR).
- Assess safety and efficacy of the VSLI + BR combination therapy.
Main Methods:
- Utilized the Escalation with Overdose Control (EWOC) model for dose determination.
- Administered 6 cycles of standard BR with escalating VSLI doses.
- Monitored adverse events (AEs), overall response rate (ORR), and complete response (CR).
Main Results:
- VSLI dose escalated from 1.80 to 2.24 mg/m², with MTD determined at 2.25 mg/m².
- Most common AEs included lymphopenia, constipation, and nausea; Grade 3/4 AEs noted.
- Achieved 100% ORR with 50% CR, but 40% of patients experienced recurrence within 26 months.
Conclusions:
- VSLI at 2.25 mg/m² can be safely combined with BR for BCL.
- Observed toxicities and recurrences led to the decision not to expand the cohort.
- Further investigation may be warranted with modifications to mitigate toxicity and improve outcomes.
