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Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell

Primary Purpose

Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
gemcitabine
mitoxantrone
rituximab
Sponsored by
US Oncology Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stage III or IV, histologically confirmed relapsed or refractory MCL as reviewed by the SI
  • Is CD20 positive (by immunohistochemistry or FACS)
  • Is Cyclin D positive (by immunohistochemistry or FACS)
  • Has received prior chemotherapy (required minimum of 1 prior therapies)
  • Has received prior treatment with Rituxan
  • Has an ECOG Performance Status (PS) 0-2
  • Is greater than or equal to 18 years of age
  • Has appropriate laboratory values (please refer to protocol for specific laboratory values)
  • If a history of cardiac disease is indicated, patient has an LVEF greater than or equal to 50% (MUGA)
  • Has a negative serum pregnancy test within 7 days prior to registration (female patients of childbearing potential)
  • If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 2 months thereafter
  • Has signed a Patient Informed Consent Form
  • Has signed a Patient Authorization Form

Exclusion Criteria:

  • Has other lymphomas not classified as MCL
  • Has had prior treatment with Gemzar and/or Novantrone
  • A history of known hypersensitivity to Gemzar, Novantrone, Rituxan, or any component of these drugs
  • Has a history of hypersensitivity to murine-cell derived therapeutics
  • Has a LVEF indicative of a cardiac condition (LVEF < 50%)
  • Is receiving concurrent immunotherapy
  • Has evidence of CNS involvement
  • Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
  • Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs
  • Is a pregnant or nursing woman
  • Is unable to comply with requirements of study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Experimental arm

    Arm Description

    Patients will be treated a maximum of 8 cycles or until the patient has evidence of a response, progressive disease, or until intolerable toxicity develops. Patients with a complete response will receive an additional 2 cycles of treatment (not to exceed 8 cycles). Drug order is gemcitabine, mitoxantrone, and rituximab.

    Outcomes

    Primary Outcome Measures

    Objective Response Rate (CR + PR)
    Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

    Secondary Outcome Measures

    Duration of Response
    The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
    Overall Survival (OS) Rate at 1 Year
    OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
    Progression-free Survival Rate at 1 Year.
    PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.

    Full Information

    First Posted
    April 4, 2008
    Last Updated
    September 15, 2016
    Sponsor
    US Oncology Research
    Collaborators
    Eli Lilly and Company
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00656084
    Brief Title
    Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell
    Official Title
    A Phase II Study of Gemzar, Novantrone and Rituxan in Relapsed or Refractory Mantle Cell Lymphoma (MCL) (B9E-US-X436)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2004 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    January 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    US Oncology Research
    Collaborators
    Eli Lilly and Company

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Relapsed or Refractory Mantle Cell Lymphoma (MCL)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental arm
    Arm Type
    Experimental
    Arm Description
    Patients will be treated a maximum of 8 cycles or until the patient has evidence of a response, progressive disease, or until intolerable toxicity develops. Patients with a complete response will receive an additional 2 cycles of treatment (not to exceed 8 cycles). Drug order is gemcitabine, mitoxantrone, and rituximab.
    Intervention Type
    Drug
    Intervention Name(s)
    gemcitabine
    Other Intervention Name(s)
    Gemzar
    Intervention Description
    900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar-->Novantrone-->Rituxan.
    Intervention Type
    Drug
    Intervention Name(s)
    mitoxantrone
    Other Intervention Name(s)
    Novantrone
    Intervention Description
    Novantrone 10 mg/m2on Day 1. The order of administration will be: Gemzar-->Novantrone-->Rituxan.
    Intervention Type
    Drug
    Intervention Name(s)
    rituximab
    Other Intervention Name(s)
    Rituxan
    Intervention Description
    Rituxan 375 mg/m2 on Day 1. The order of administration will be: Gemzar-->Novantrone-->Rituxan.
    Primary Outcome Measure Information:
    Title
    Objective Response Rate (CR + PR)
    Description
    Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Duration of Response
    Description
    The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
    Time Frame
    From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 33 months.
    Title
    Overall Survival (OS) Rate at 1 Year
    Description
    OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
    Time Frame
    1 year.
    Title
    Progression-free Survival Rate at 1 Year.
    Description
    PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
    Time Frame
    1 year.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Stage III or IV, histologically confirmed relapsed or refractory MCL as reviewed by the SI Is CD20 positive (by immunohistochemistry or FACS) Is Cyclin D positive (by immunohistochemistry or FACS) Has received prior chemotherapy (required minimum of 1 prior therapies) Has received prior treatment with Rituxan Has an ECOG Performance Status (PS) 0-2 Is greater than or equal to 18 years of age Has appropriate laboratory values (please refer to protocol for specific laboratory values) If a history of cardiac disease is indicated, patient has an LVEF greater than or equal to 50% (MUGA) Has a negative serum pregnancy test within 7 days prior to registration (female patients of childbearing potential) If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 2 months thereafter Has signed a Patient Informed Consent Form Has signed a Patient Authorization Form Exclusion Criteria: Has other lymphomas not classified as MCL Has had prior treatment with Gemzar and/or Novantrone A history of known hypersensitivity to Gemzar, Novantrone, Rituxan, or any component of these drugs Has a history of hypersensitivity to murine-cell derived therapeutics Has a LVEF indicative of a cardiac condition (LVEF < 50%) Is receiving concurrent immunotherapy Has evidence of CNS involvement Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs Is a pregnant or nursing woman Is unable to comply with requirements of study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lawrence Garbo, MD
    Organizational Affiliation
    US Oncology Research
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell

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