Relapsed or Refractory Mantle Cell Lymphoma (MCL) Clinical Trial
Official title:
A Phase II Study of Gemzar, Novantrone and Rituxan in Relapsed or Refractory Mantle Cell Lymphoma (MCL) (B9E-US-X436)
| Verified date | April 2010 |
| Source | US Oncology Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL
| Status | Completed |
| Enrollment | 23 |
| Est. completion date | January 2008 |
| Est. primary completion date | January 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| US Oncology Research | Eli Lilly and Company |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Primary Objective | To determine the efficacy (response rate) produced by the combination of Gemzar,Novantrone, and Rituxan in relapsed or refractory MCL | Throughout study and at end of study | No |
| Secondary | Secondary objectives | 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 |
Throughout study, at end of study and up to 30 days following last dose. | Yes |