Overview

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.