Clinical trial · Interventional
Vincristine Sulfate Liposome Injection (Marqibo®), Bendamustine and Rituximab-Phase I Trial in Indolent B-cell Lymphoma
BrUOG 326: A Phase I Dose-Escalation Study of Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With Bendamustine and Rituximab (BRiM) in Indolent Non-Hodgkin Lymphoma
NCT02257242CI-TRIAL-00063802BRiMcompletedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates addition of Vincristine Sulfate Liposome Injection (Marqibo®) to the standard regimen of Bendamustine and Rituximab in adult patients with indolent B-cell lymphoma. This is a dose-escalation study.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, B-Cell, Marginal Zone | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Follicular | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Mantle-Cell | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoma, Small-Cell | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Waldenstrom Macroglobulinemia | Waldenstrom Macroglobulinemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine sulfate liposome injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- Vincristine sulfate liposome injection 1.8 mg/m^2
- description
- Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
- interventionNames
- Drug: Rituximab
- Drug: Bendamustine
- Drug: Vincristine sulfate liposome injection
- type
- EXPERIMENTAL
- label
- Vincristine sulfate liposome injection 1.95 mg/m^2
- description
- Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
- interventionNames
- Drug: Rituximab
- Drug: Bendamustine
- Drug: Vincristine sulfate liposome injection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed indolent B-cell non-Hodgkin lymphoma. * Radiological measurable disease. * Previous treatment for lymphoma is allowed, with the exception of use of bendamustine within 6 months or any prior use of vincristine sulfate liposome injection * Eastern Cooperative Oncology Group performance status 0 or 1; * Life expectancy of at least 6 months; * Adequate organ and marrow function; * Women of child-bearing potential and men must agree to use adequate contraception. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * History of allergic reactions attributed to any drug used in the study. * Any lymphoma-directed therapy within 4 weeks. * Any prior treatment with vincristine sulfate liposome injection. * Prior treatment with bendamustine or vincristine sulfate within 180 days of enrollment. * Patients who are receiving any other investigational agents with the exception of endocrine therapy for breast or prostate cancer. * Central nervous system involvement. * Peripheral sensory or motor neuropathy. * History of a demyelinating condition. * Positive test for the Human Anti-Chimeric Antibody (HACA). * Patients receiving any medications or substances that are strong inhibitors or inducers of Cytochrome P450, family 3, subfamily A (CYP3A) enzyme are ineligible. * Uncontrolled intercurrent illness. * Prisoners. * Pregnant or breast-feeding women. * Known Human Immunodeficiency Virus (HIV) or active Hepatitis B infection * Any prior or active cancer, which in the opinion of the investigator would preclude safe participation in this study.
References
Publications (1)
- DERIVEDOllila T, Butera J, Egan P, Reagan J, Thomas A, Yakirevich I, MacKinnon K, Margolis J, McMahon J, Rosati V, Olszewski AJ. Vincristine Sulfate Liposome Injection with Bendamustine and Rituximab as First-Line Therapy for B-Cell Lymphomas: A Phase I Study. Oncologist. 2022 Jul 5;27(7):532-e542. doi: 10.1093/oncolo/oyab079. PMID 35641232