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Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell

Information source: US Oncology Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Intervention: gemcitabine (Drug); mitoxantrone (Drug); rituximab (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: US Oncology Research

Official(s) and/or principal investigator(s):
Lawrence Garbo, MD, Principal Investigator, Affiliation: US Oncology Research

Summary

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

Clinical Details

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

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

Primary outcome: Primary Objective

Secondary outcome: Secondary objectives

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: December 2004
Last updated: April 5, 2010

Page last updated: August 23, 2015

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