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

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ClinicalTrials.gov Identifier: NCT02257242
Recruitment Status : Recruiting
First Posted : October 6, 2014
Last Update Posted : July 9, 2019
Sponsor:
Collaborators:
Spectrum Pharmaceuticals, Inc
Rhode Island Hospital
The Miriam Hospital
Information provided by (Responsible Party):
Adam Olszewski, Brown University

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.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Lymphoma, Follicular Lymphoma, Mantle-Cell Lymphoma, Small-Cell Waldenstrom Macroglobulinemia Lymphoma, B-Cell, Marginal Zone Drug: Rituximab Drug: Bendamustine Drug: Vincristine sulfate liposome injection Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: Dose-escalation cohort
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.
Drug: Rituximab
375 mg/m2 I.V. on Day 1 of each cycle
Other Name: Rituxan, anti-CD20 antibody

Drug: Bendamustine
90 mg/m2 I.V. on Day 1 and 2 of each cycle
Other Name: Treanda

Drug: Vincristine sulfate liposome injection
Dose per dose escalation protocol, I.V. on Day 2 of each cycle
Other Name: Marqibo




Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: Calculated within 6 months of the enrollment of the last subject - by December 2017 ]
    Determined as the median of the marginal posterior distribution using data from all available patients


Secondary Outcome Measures :
  1. Cumulative toxicity rate [ Time Frame: Calculated within 6 months of the enrollment of the last subject - by December 2017 ]
    Cumulative rate of adverse effects during treatment on study

  2. Rate of treatment completion [ Time Frame: Calculated within 6 months of the enrollment of the last subject - by December 2017 ]
    Proportion of patients completing the six planned cycles of study treatment

  3. Response rate [ Time Frame: Calculated within 6 months of the enrollment of the last subject - by December 2017 ]
    The proportion of patients achieving at least partial response during treatment on study

  4. Complete response rate [ Time Frame: Calculated within 6 months of the enrollment of the last subject - by December 2017 ]
    The proportion of patients achieving complete response during treatment on study



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02257242


Contacts
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Contact: Helena Lau, MSPH 401-863-3000 helena_lau@brown.edu

Locations
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United States, Rhode Island
Helena Lau Recruiting
Providence, Rhode Island, United States, 02903
Contact: Helena Lau, MSPH    401-863-3000    helena_lau@brown.edu   
Principal Investigator: Adam J Olszewski, MD         
Sponsors and Collaborators
Adam Olszewski
Spectrum Pharmaceuticals, Inc
Rhode Island Hospital
The Miriam Hospital
Investigators
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Principal Investigator: Adam J Olszewski, MD Rhode Island Hospital

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Responsible Party: Adam Olszewski, Assistant Professor of Medicine, Brown University
ClinicalTrials.gov Identifier: NCT02257242     History of Changes
Other Study ID Numbers: BrUOG 326
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adam Olszewski, Brown University:
Bendamustine
Rituximab
Vincristine sulfate
Vincristine sulfate liposome injection
Phase I
Escalation With Overdose Control

Additional relevant MeSH terms:
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Vincristine
Lymphoma
Waldenstrom Macroglobulinemia
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Follicular
Lymphoma, Mantle-Cell
Lymphoma, B-Cell, Marginal Zone
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Rituximab
Bendamustine Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents