Clinical trial NCT00656084: Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell
Official title: A Phase II Study of Gemzar, Novantrone and Rituxan in Relapsed or Refractory Mantle Cell Lymphoma (MCL) (B9E-US-X436)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Lead sponsor: US Oncology Research
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2008-04-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Objective Response Rate (CR + PR)
timeFrame: 2 years
Secondary outcomes:
measure: Duration of Response
timeFrame: 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.
measure: Overall Survival (OS) Rate at 1 Year
timeFrame: 1 year.
measure: Progression-free Survival Rate at 1 Year.
timeFrame: 1 year.
Other outcomes:
Locations:
Study officials:
affiliation: US Oncology Research
name: Lawrence Garbo, MD
role: PRINCIPAL_INVESTIGATOR
References: