Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma
Condition: Relapsed Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: rituximab; cyclophosphamide; doxorubicin; VELCADE; prednisone
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase 2, two-arm, non-randomized, open-label, multicenter study evaluating the
      safety and efficacy of 2 VELCADE-containing regimens. Patients will be treated with either a
      combination of VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone
      (VELCADE-R-CAP) or a combination of VELCADE, rituximab, cyclophosphamide, and prednisone
      (VELCADE-R-CP) based on investigator preference. Following completion of the treatment
      period, patients will receive maintenance therapy with rituximab up to a maximum of 2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patient 18 years of age or older

          -  Pathological diagnosis of follicular lymphoma (any grade) or marginal zone lymphoma.
             Patients with transformed follicular lymphoma are eligible, provided there has
             previously been pathologic documentation of follicular lymphoma.

          -  Documented relapse or progression following prior antineoplastic therapy

          -  At least 1 measurable tumor mass that is greater than 1.5 cm in the long axis and
             greater than 1.0 cm in the short axis that has not been previously irradiated, or has
             grown since previous irradiation

          -  No clinically significant evidence of active central nervous system lymphoma

          -  Karnofsky performance status (KPS) ≥50 (equivalent to Eastern Cooperative Group
             Oncology Group [ECOG] status ≤2)

        Exclusion Criteria:

          -  Diagnosed or treated for a malignancy other than Non-Hodgkin's Lymphoma (NHL) within 2
             years of first dose, or who were previously diagnosed with a malignancy other than NHL
             and have any radiographic or biochemical marker evidence of malignancy. Patients with
             prostate cancer who were treated with definitive radiotherapy who have a serum
             prostate-specific antigen <1 ng/mL are not excluded. Patients are not excluded if they
             have had basal cell or squamous cell carcinoma of the skin that was completely
             resected, or any in situ malignancy that was adequately treated.

          -  Received any of the following treatments or procedures outside of the specified
             timeframes:

               -  Prior treatment with VELCADE

               -  Prior treatment with a cumulative dose of doxorubicin of more than 100 mg/m2, if
                  assigned to Arm A (VELCADE-R-CAP)

               -  Antineoplastic (including unconjugated therapeutic antibodies and toxin
                  immunoconjugates), experimental, or radiation therapy within 3 weeks before Day 1
                  of Cycle 1

               -  Nitrosoureas within 6 weeks before Day 1 of Cycle 1

               -  Radioimmunoconjugates within 10 weeks before Day 1 of Cycle 1

               -  Autologous stem cell transplant within 3 months before Day 1 of Cycle 1, or prior
                  allogeneic stem cell transplant at any time

               -  Major surgery within 2 weeks before Day 1 of Cycle 1