Clinical Trials /

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

NCT02257242

Description:

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.

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: BrUOG 326
  • NCT ID: NCT02257242

Conditions

  • Lymphoma, Non-Hodgkin
  • Lymphoma, Follicular
  • Lymphoma, Mantle-Cell
  • Lymphoma, Small-Cell
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell, Marginal Zone

Interventions

DrugSynonymsArms
RituximabRituxan, anti-CD20 antibodyDose-escalation cohort
BendamustineTreandaDose-escalation cohort
Vincristine sulfate liposome injectionMarqiboDose-escalation cohort

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Dose-escalation cohortExperimentalTreatment 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.
  • Rituximab
  • Bendamustine
  • Vincristine sulfate liposome injection

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum tolerated dose
Time Frame:Calculated within 6 months of the enrollment of the last subject - by December 2017
Safety Issue:
Description:Determined as the median of the marginal posterior distribution using data from all available patients

Secondary Outcome Measures

Measure:Cumulative toxicity rate
Time Frame:Calculated within 6 months of the enrollment of the last subject - by December 2017
Safety Issue:
Description:Cumulative rate of adverse effects during treatment on study
Measure:Rate of treatment completion
Time Frame:Calculated within 6 months of the enrollment of the last subject - by December 2017
Safety Issue:
Description:Proportion of patients completing the six planned cycles of study treatment
Measure:Response rate
Time Frame:Calculated within 6 months of the enrollment of the last subject - by December 2017
Safety Issue:
Description:The proportion of patients achieving at least partial response during treatment on study
Measure:Complete response rate
Time Frame:Calculated within 6 months of the enrollment of the last subject - by December 2017
Safety Issue:
Description:The proportion of patients achieving complete response during treatment on study

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Adam Olszewski

Trial Keywords

  • Bendamustine
  • Rituximab
  • Vincristine sulfate
  • Vincristine sulfate liposome injection
  • Phase I
  • Escalation With Overdose Control

Last Updated

July 8, 2019