Phase 1
N=11
Vincristine Sulfate Liposome Injection (Marqibo®), Bendamustine and Rituximab-Phase I Trial in Indolent B-cell Lymphoma
Lymphoma, Non-Hodgkin · Lymphoma, Follicular · Lymphoma, Mantle-Cell · Lymphoma, Small-Cell · Waldenstrom Macroglobulinemia
Bottom Line
View on ClinicalTrials.gov: NCT02257242 ↗Enrolled (actual)
11
Serious AEs
20.0%
Results posted
Feb 2023
Primary outcome: Primary: Maximum Tolerated Dose — 2.24 mg/m^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Rituximab (Drug); Bendamustine (Drug); Vincristine sulfate liposome injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brown University
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose |
2.24 | — |
| SECONDARY Number of Participants Who Completed Six Cycles of Study Treatment |
1; 0; 1; 1; 1; 1 | — |
| SECONDARY Response Rate |
1; 0; 0; 1; 0; 1 | — |
| SECONDARY Complete Response Rate |
1; 0; 0; 1; 0; 1 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02257242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.