Vincristine Sulfate Liposome Injection (Marqibo®), Bendamustine and Rituximab-Phase I Trial in Indolent B-cell Lymphoma

• Status: Active, not recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adam Olszewski
• Collaborators: Rhode Island Hospital; Spectrum Pharmaceuticals, Inc; The Miriam Hospital
• Treatments: Bendamustine Hydrochloride; Rituximab; Vincristine

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.