Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma
Condition: Lymphoma, Follicular
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: Bortezomib; Rituximab; Fludarabine; Mitoxantrone; Dexamethasone
Intervention description: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle; Rituximab 375 mg/m2 IV on day 1; Fludarabine 25 mg/m2 IV on days 1,2,3; Mitoxantrone 10 mg/m2 IV on day 2; Dexamethasone 20 mg orally on days 1,2,3,4,5
Intervention MeSH terms: Dexamethasone; Rituximab; Fludarabine; Bortezomib; Mitoxantrone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: follicular lymphoma; Velcade; VR-FND

Summary:

      The purpose of this study is to evaluate the effectiveness and safety of combining bortezomib
      (Velcade) with rituximab, fludarabine, mitoxantrone, and dexamethasone in treating patients
      with follicular cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of grade 1-3 follicular lymphoma with persistent, relapsed, or refractory
             disease to at least one prior regimen.

          -  No prior bortezomib therapy.

          -  Voluntary written informed consent.

          -  Female subject is either post-menopausal or surgically sterilized or willing to use an
             acceptable method of birth control.

          -  Male subject agrees to use an acceptable method for contraception for the duration of
             the study therapy.

          -  18 years of age or older.

          -  aspartate aminotransferase (AST),alanine aminotransferase (ALT), total bilirubin < 3
             times the upper limit of normal unless documented by the treating physician to be
             secondary to underlying lymphoma.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

        Exclusion Criteria:

          -  Platelet count of < 50,000 within 14 days before enrollment unless documented by the
             treating physician to be due to the disease.

          -  Absolute neutrophil count of < 1000 within 14 days before enrollment unless documented
             by the treating physician to be due to disease.

          -  Estimated or measured creatinine clearance of less than 30 ml/min within 14 days
             before enrollment.

          -  ≥Grade 2 peripheral neuropathy within 14 days before enrollment.

          -  Myocardial infarction within 6 months prior to enrollment or has New York Hospital
             Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
             uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
             ischemia.

          -  Patient has hypersensitivity to boron, mannitol or any drug included in the current
             protocol.

          -  Female subject is pregnant or lactating.

          -  Received other investigational drugs for this disease within 14 days of enrollment

          -  Serious medical or psychiatric illness likely to interfere with participation in this
             clinical study.

          -  Known HIV+ status.

          -  Cardiac ejection fraction less than 35% at study entry measured by echocardiogram,
             Multigated Acquisition (MUGA) or cardiac MRI.