Lymphoma, Non-Hodgkin Clinical Trial
— BRiMOfficial 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
Verified date | May 2022 |
Source | Brown University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | November 18, 2020 |
Est. primary completion date | August 22, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Rhode Island Hospital and The Miriam Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Brown University | Rhode Island Hospital, Spectrum Pharmaceuticals, Inc, The Miriam Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose | Determined as the median of the marginal posterior distribution using data from all available patients | Up to 6 cycles of treatment (approximately 6 months) | |
Secondary | Number of Participants Who Completed Six Cycles of Study Treatment | Up to 6 cycles of treatment (approximately 6 months) | ||
Secondary | Response Rate | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR | Up to 6 cycles of treatment (approximately 6 months) | |
Secondary | Complete Response Rate | The number of patients achieving complete response during treatment on study | Up to 6 cycles of treatment (approximately 6 months) |
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