Brief Title
Vincristine Sulfate Liposome Injection (Marqibo®), Bendamustine and Rituximab-Phase I Trial in Indolent B-cell Lymphoma
Official Title
BrUOG 326: A Phase I Dose-Escalation Study of Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With Bendamustine and Rituximab (BRiM) in Indolent Non-Hodgkin Lymphoma
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-escalation study.
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 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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Maximum tolerated dose
Secondary Outcome
Cumulative toxicity rate
Condition
Lymphoma, Non-Hodgkin
Intervention
Rituximab
Study Arms / Comparison Groups
Dose-escalation cohort
Description: Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
11
Start Date
May 10, 2017
Completion Date
June 2021
Primary Completion Date
August 22, 2020
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Adam J Olszewski, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02257242
Organization ID
BrUOG 326
Responsible Party
Sponsor-Investigator
Study Sponsor
Adam Olszewski
Collaborators
Spectrum Pharmaceuticals, Inc
Study Sponsor
Adam J Olszewski, MD, Principal Investigator, Rhode Island Hospital
Verification Date
August 2020