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Completed

NCT Number: NCT00656084

Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell

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

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Key information

Conditions

Relapsed or Refractory Mantle Cell Lymphoma (MCL) Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemcitabine

Drug

900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar-->Novantrone-->Rituxan.

Other names: Gemzar

Mitoxantrone

Drug

Novantrone 10 mg/m2on Day 1. The order of administration will be:

Gemzar-->Novantrone-->Rituxan.

Other names: Novantrone

Rituximab

Drug

Rituxan 375 mg/m2 on Day 1. The order of administration will be:

Gemzar-->Novantrone-->Rituxan.

Other names: Rituxan

Primary outcomes

  1. Objective Response Rate (CR + PR)

    Time frame: 2 years

    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 outcomes

  1. Duration of Response

    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.

    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.

  2. Overall Survival (OS) Rate at 1 Year

    Time frame: 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.

  3. Progression-free Survival Rate at 1 Year.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

US Oncology Research

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

A Phase II Study of Gemzar, Novantrone and Rituxan in Relapsed or Refractory Mantle Cell Lymphoma (MCL) (B9E-US-X436)

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Apr 10, 2008
Registry last updated
Nov 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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