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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: September 15, 2016
Last verified: September 2016
  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:


Further study details as provided by US Oncology Research:

Primary Outcome Measures:
  • Objective Response Rate (CR + PR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ 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. ] [ Designated as safety issue: No ]

    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 [ Time Frame: 1 year. ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 year. ] [ Designated as safety issue: No ]
    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.


Enrollment: 16
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Results First Received: February 2, 2016
Last Updated: September 15, 2016
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
Mitoxantrone
Rituximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on December 09, 2016