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Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell
This study has been completed.
Sponsors and Collaborators: US Oncology Research
Eli Lilly and Company
Information provided by: US Oncology Research
ClinicalTrials.gov Identifier: NCT00656084
  Purpose

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


Condition Intervention Phase
Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Drug: Gemzar
Phase II

MedlinePlus related topics: Lymphoma
Drug Information available for: Mitoxantrone hydrochloride Mitoxantrone Gemcitabine hydrochloride Gemcitabine Rituximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment
Official Title: A Phase II Study of Gemzar, Novantrone and Rituxan in Relapsed or Refractory Mantle Cell Lymphoma (MCL) (B9E-US-X436)

Further study details as provided by US Oncology Research:

Enrollment: 23
Study Start Date: December 2004
Study Completion Date: January 2008
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Each 21 day cycle: Experimental
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: Gemzar
This is a nonrandomized, Phase II, open-label study. Patients will receive Gemzar, Novantrone, and Rituxan on Day 1. On Day 8 of each 21 day cycle Gemzar will be administered. The order of administration will be: Gemzar then Novantrone and then Rituxan.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Study ID Numbers: 04-026
Study First Received: April 4, 2008
Last Updated: April 9, 2008
ClinicalTrials.gov Identifier: NCT00656084  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
Lymphoma, Mantle-Cell
Mitoxantrone
Gemcitabine
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Mantle cell lymphoma
Lymphoma

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on January 16, 2009