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Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
US Oncology Research
ClinicalTrials.gov Identifier:
NCT00656084
First received: April 4, 2008
Last updated: April 5, 2010
Last verified: April 2010
History of Changes

April 4, 2008
April 5, 2010
December 2004
January 2007   (final data collection date for primary outcome measure)
Primary Objective [ Time Frame: Throughout study and at end of study ] [ Designated as safety issue: No ]
To determine the efficacy (response rate) produced by the combination of Gemzar,Novantrone, and Rituxan in relapsed or refractory MCL
Not Provided
Complete list of historical versions of study NCT00656084 on ClinicalTrials.gov Archive Site
Secondary objectives [ Time Frame: Throughout study, at end of study and up to 30 days following last dose. ] [ Designated as safety issue: Yes ]

To determine the duration of response, survival at 1- year, and progression- free survival produced by this combination

To determine toxicity of this combination, especially myelotoxicity
Not Provided
Not Provided
Not Provided
 
Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell
A Phase II Study of Gemzar, Novantrone and Rituxan in Relapsed or Refractory Mantle Cell Lymphoma (MCL) (B9E-US-X436)

To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Relapsed or Refractory Mantle Cell Lymphoma (MCL)
  • Drug: gemcitabine
    900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar-->Novantrone-->Rituxan.
    Other Name: Gemzar
  • Drug: mitoxantrone

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

    Gemzar-->Novantrone-->Rituxan.

    Other Name: Novantrone
  • Drug: rituximab

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

    Gemzar-->Novantrone-->Rituxan.

    Other Name: Rituxan
Experimental: Experimental arm
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.
Interventions:
  • Drug: gemcitabine
  • Drug: mitoxantrone
  • Drug: rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
January 2008
January 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00656084
04-026
No
Dr. Lawrence Garbo, Principal Investigator, US Oncology Research
US Oncology Research
Eli Lilly and Company
Principal Investigator: Lawrence Garbo, MD US Oncology Research
US Oncology Research
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP