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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
  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: gemcitabine
Drug: mitoxantrone
Drug: rituximab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Gemzar, Novantrone and Rituxan in Relapsed or Refractory Mantle Cell Lymphoma (MCL) (B9E-US-X436)

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by US Oncology Research:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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



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
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.
 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

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00656084

Sponsors and Collaborators
US Oncology Research
Eli Lilly and Company
Investigators
Principal Investigator: Lawrence Garbo, MD US Oncology Research
  More Information

No publications provided

Responsible Party: Dr. Lawrence Garbo, Principal Investigator, US Oncology Research
ClinicalTrials.gov Identifier: NCT00656084     History of Changes
Other Study ID Numbers: 04-026
Study First Received: April 4, 2008
Last Updated: April 5, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Gemcitabine
Rituximab
Mitoxantrone
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Radiation-Sensitizing Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013