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NCT02257242 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2023-02-09

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Maximum Tolerated Dose

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outcome · POSTED

Number of Participants Who Completed Six Cycles of Study Treatment

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outcome · POSTED

Response Rate

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outcome · POSTED

Complete Response Rate

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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.
    intervention Names
    1. Drug: Rituximab
    2. Drug: Bendamustine
    3. Drug: Vincristine sulfate liposome injection
    label
    Vincristine sulfate liposome injection 1.8 mg/m^2
    type
    EXPERIMENTAL
  2. 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.
    intervention Names
    1. Drug: Rituximab
    2. Drug: Bendamustine
    3. Drug: Vincristine sulfate liposome injection
    label
    Vincristine sulfate liposome injection 1.95 mg/m^2
    type
    EXPERIMENTAL
  3. 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.
    intervention Names
    1. Drug: Rituximab
    2. Drug: Bendamustine
    3. Drug: Vincristine sulfate liposome injection
    label
    Vincristine sulfate liposome injection 1.98 mg/m^2
    type
    EXPERIMENTAL
  4. 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.
    intervention Names
    1. Drug: Rituximab
    2. Drug: Bendamustine
    3. Drug: Vincristine sulfate liposome injection
    label
    Vincristine sulfate liposome injection 2.04 mg/m^2
    type
    EXPERIMENTAL
  5. 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.
    intervention Names
    1. Drug: Rituximab
    2. Drug: Bendamustine
    3. Drug: Vincristine sulfate liposome injection
    label
    Vincristine sulfate liposome injection 2.10 mg/m^2
    type
    EXPERIMENTAL
  6. 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.
    intervention Names
    1. Drug: Rituximab
    2. Drug: Bendamustine
    3. Drug: Vincristine sulfate liposome injection
    label
    Vincristine sulfate liposome injection 2.14 mg/m^2
    type
    EXPERIMENTAL
  7. 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.
    intervention Names
    1. Drug: Rituximab
    2. Drug: Bendamustine
    3. Drug: Vincristine sulfate liposome injection
    label
    Vincristine sulfate liposome injection 2.19 mg/m^2
    type
    EXPERIMENTAL
  8. 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.
    intervention Names
    1. Drug: Rituximab
    2. Drug: Bendamustine
    3. Drug: Vincristine sulfate liposome injection
    label
    Vincristine sulfate liposome injection 2.22 mg/m^2
    type
    EXPERIMENTAL
  9. 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.
    intervention Names
    1. Drug: Rituximab
    2. Drug: Bendamustine
    3. Drug: Vincristine sulfate liposome injection
    label
    Vincristine sulfate liposome injection 2.24 mg/m^2
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Vincristine sulfate liposome injection 1.8 mg/m^2
    2. Vincristine sulfate liposome injection 1.95 mg/m^2
    3. Vincristine sulfate liposome injection 1.98 mg/m^2
    4. Vincristine sulfate liposome injection 2.04 mg/m^2
    5. Vincristine sulfate liposome injection 2.10 mg/m^2
    6. Vincristine sulfate liposome injection 2.14 mg/m^2
    7. Vincristine sulfate liposome injection 2.19 mg/m^2
    8. Vincristine sulfate liposome injection 2.22 mg/m^2
    9. Vincristine sulfate liposome injection 2.24 mg/m^2
    description
    375 mg/m2 I.V. on Day 1 of each cycle
    name
    Rituximab
    other Names
    1. Rituxan, anti-CD20 antibody
    type
    DRUG
  2. arm Group Labels
    1. Vincristine sulfate liposome injection 1.8 mg/m^2
    2. Vincristine sulfate liposome injection 1.95 mg/m^2
    3. Vincristine sulfate liposome injection 1.98 mg/m^2
    4. Vincristine sulfate liposome injection 2.04 mg/m^2
    5. Vincristine sulfate liposome injection 2.10 mg/m^2
    6. Vincristine sulfate liposome injection 2.14 mg/m^2
    7. Vincristine sulfate liposome injection 2.19 mg/m^2
    8. Vincristine sulfate liposome injection 2.22 mg/m^2
    9. Vincristine sulfate liposome injection 2.24 mg/m^2
    description
    90 mg/m2 I.V. on Day 1 and 2 of each cycle
    name
    Bendamustine
    other Names
    1. Treanda
    type
    DRUG
  3. arm Group Labels
    1. Vincristine sulfate liposome injection 1.8 mg/m^2
    2. Vincristine sulfate liposome injection 1.95 mg/m^2
    3. Vincristine sulfate liposome injection 1.98 mg/m^2
    4. Vincristine sulfate liposome injection 2.04 mg/m^2
    5. Vincristine sulfate liposome injection 2.10 mg/m^2
    6. Vincristine sulfate liposome injection 2.14 mg/m^2
    7. Vincristine sulfate liposome injection 2.19 mg/m^2
    8. Vincristine sulfate liposome injection 2.22 mg/m^2
    9. Vincristine sulfate liposome injection 2.24 mg/m^2
    description
    Dose per dose escalation protocol, I.V. on Day 2 of each cycle
    name
    Vincristine sulfate liposome injection
    other Names
    1. Marqibo
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
11
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Determined as the median of the marginal posterior distribution using data from all available patients
    measure
    Maximum Tolerated Dose
    time Frame
    Up to 6 cycles of treatment (approximately 6 months)
secondary Outcomes
  1. measure
    Number of Participants Who Completed Six Cycles of Study Treatment
    time Frame
    Up to 6 cycles of treatment (approximately 6 months)
  2. description
    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
    measure
    Response Rate
    time Frame
    Up to 6 cycles of treatment (approximately 6 months)
  3. description
    The number of patients achieving complete response during treatment on study
    measure
    Complete Response Rate
    time Frame
    Up to 6 cycles of treatment (approximately 6 months)
Full study description
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.
Source references
references
  1. citation
    Ollila T, Butera J, Egan P, Reagan J, Thomas A, Yakirevich I, MacKinnon K, Margolis J, McMahon J, Rosati V, Olszewski AJ. Vincristine Sulfate Liposome Injection with Bendamustine and Rituximab as First-Line Therapy for B-Cell Lymphomas: A Phase I Study. Oncologist. 2022 Jul 5;27(7):532-e542. doi: 10.1093/oncolo/oyab079.
    pmid
    35641232
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice