Vincristine Sulfate Liposome Injection (Marqibo®), Bendamustine and Rituximab-Phase I Trial in Indolent B-cell Lymphoma
Condition: Lymphoma, Non-Hodgkin; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Lymphoma, Small-Cell; Waldenstrom Macroglobulinemia; Lymphoma, B-Cell, Marginal Zone
MeSH terms: Lymphoma; Waldenstrom Macroglobulinemia; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Rituximab; Bendamustine; Vincristine sulfate liposome injection
Intervention description: 375 mg/m2 I.V. on Day 1 of each cycle; 90 mg/m2 I.V. on Day 1 and 2 of each cycle; Dose per dose escalation protocol, I.V. on Day 2 of each cycle
Intervention MeSH terms: Rituximab; Vincristine; Bendamustine Hydrochloride
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bendamustine; Rituximab; Vincristine sulfate; Vincristine sulfate liposome injection; Phase I; Escalation With Overdose Control

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.