Providence, Rhode Island 02903


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.


Study summary:

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.


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. - 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


NCT ID:

NCT02257242


Primary Contact:

Principal Investigator
Adam J Olszewski, MD
Rhode Island Hospital

Kayla Rosati, EdM, CCRP
Phone: 401-863-3000
Email: kayla_rosati@brown.edu


Backup Contact:

N/A


Location Contact:

Providence, Rhode Island 02903
United States

Kayla Rosati
Phone: 401-863-3000
Email: kayla_rosati@brown.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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