Description:
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.
Title
- Brief Title: Vincristine Sulfate Liposome Injection (Marqibo®), Bendamustine and Rituximab-Phase I Trial in Indolent B-cell Lymphoma
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
BrUOG 326
- NCT ID:
NCT02257242
Conditions
- Lymphoma, Non-Hodgkin
- Lymphoma, Follicular
- Lymphoma, Mantle-Cell
- Lymphoma, Small-Cell
- Waldenstrom Macroglobulinemia
- Lymphoma, B-Cell, Marginal Zone
Interventions
Drug | Synonyms | Arms |
---|
Rituximab | Rituxan, anti-CD20 antibody | Dose-escalation cohort |
Bendamustine | Treanda | Dose-escalation cohort |
Vincristine sulfate liposome injection | Marqibo | Dose-escalation cohort |
Purpose
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.
Detailed Description
Bendamustine-rituximab is a standard chemotherapy regimen for treatment of many indolent
B-cell lymphomas, but most patients experience a recurrence of the lymphoma. Vincristine
sulfate has been a traditional component of chemotherapy regimens in non-Hodgkin lymphoma and
it is possible that adding it to the bendamustine-rituximab regimen might provide a better
quality of remissions or longer duration of remissions with acceptable toxicity.
This is a phase 1, single-center, open-label, single-arm trial in patients with indolent
B-cell non-Hodgkin lymphoma otherwise appropriate for bendamustine-rituximab as initial or
subsequent line of therapy. Patients will receive the of rituximab and bendamustine in
combination with escalating doses of vincristine sulfate liposome injection (Marqibo®). The
objective of this study is to assess safety of this combination by establishing the maximum
tolerated dose of vincristine sulfate liposome injection (Marqibo®) in the combination.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose-escalation cohort | Experimental | 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. | - Rituximab
- Bendamustine
- Vincristine sulfate liposome injection
|
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Maximum tolerated dose |
Time Frame: | Calculated within 6 months of the enrollment of the last subject - by December 2017 |
Safety Issue: | |
Description: | Determined as the median of the marginal posterior distribution using data from all available patients |
Secondary Outcome Measures
Measure: | Cumulative toxicity rate |
Time Frame: | Calculated within 6 months of the enrollment of the last subject - by December 2017 |
Safety Issue: | |
Description: | Cumulative rate of adverse effects during treatment on study |
Measure: | Rate of treatment completion |
Time Frame: | Calculated within 6 months of the enrollment of the last subject - by December 2017 |
Safety Issue: | |
Description: | Proportion of patients completing the six planned cycles of study treatment |
Measure: | Response rate |
Time Frame: | Calculated within 6 months of the enrollment of the last subject - by December 2017 |
Safety Issue: | |
Description: | The proportion of patients achieving at least partial response during treatment on study |
Measure: | Complete response rate |
Time Frame: | Calculated within 6 months of the enrollment of the last subject - by December 2017 |
Safety Issue: | |
Description: | The proportion of patients achieving complete response during treatment on study |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Adam Olszewski |
Trial Keywords
- Bendamustine
- Rituximab
- Vincristine sulfate
- Vincristine sulfate liposome injection
- Phase I
- Escalation With Overdose Control
Last Updated
July 21, 2021