Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell

US Oncology Network

Status and phase: Completed; Phase 2

Conditions: Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Treatments: Drug: rituximab; Drug: gemcitabine; Drug: mitoxantrone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00656084

04-026

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Experimental arm

Experimental group

Description:

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.

Treatment:

Drug: gemcitabine

Drug: rituximab

Drug: mitoxantrone