Status:
COMPLETED
Vincristine Sulfate Liposome Injection (Marqibo®), Bendamustine and Rituximab-Phase I Trial in Indolent B-cell Lymphoma
Lead Sponsor:
Brown University
Collaborating Sponsors:
Spectrum Pharmaceuticals, Inc
Rhode Island Hospital
Conditions:
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
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 tra...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02257242
Start Date
May 10 2017
End Date
November 18 2020
Last Update
February 9 2023
Active Locations (1)
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1
Rhode Island Hospital and The Miriam Hospital
Providence, Rhode Island, United States, 02903