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

Phase 2
18 Years
Not Enrolling
Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Thank you

Trial Information

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

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary Objective

Outcome Description:

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

Outcome Time Frame:

Throughout study and at end of study

Safety Issue:


Principal Investigator

Lawrence Garbo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

US Oncology Research


United States: Institutional Review Board

Study ID:




Start Date:

December 2004

Completion Date:

January 2008

Related Keywords:

  • Relapsed or Refractory Mantle Cell Lymphoma (MCL)
  • Lymphoma
  • Lymphoma, Mantle-Cell