A Phase II Study of VELCADE (Bortezomib) in Combination With Bendamustine and Rituximab in Subjects With Relapsed or Refractory Follicular Lymphoma
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: VELCADE; Bendamustine; Rituximab
Intervention description: VELCADE administered as a 3- to 5-second intravenous (IV) bolus prior to Bendamustine and Rituximab on Days 1,8,15 and 22 of each cycle.; Bendamustine administered IV over 30-60 minutes after VELCADE on Days 1 and 2 of each cycle; Rituximab administered by IV infusion after VELCADE and Bendamustine on Days 1, 8, 15 and 22 of Cycle 1, and on Day 1 of Cycles 2, 3, 4 and 5
Intervention MeSH terms: Rituximab; Bortezomib; Bendamustine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase 2, single-arm, open label, multicenter study evaluating the efficacy and
      safety of the combination of VELCADE, bendamustine, and rituximab in subjects with relapsed
      or refractory follicular lymphoma, who have received 4 or more doses of rituximab. Subjects
      may be sensitive or refractory to prior therapies, including rituximab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject 18 years of age or older

          -  Pathological diagnosis of follicular lymphoma (any grade)

          -  Documented relapse or progression following prior antineoplastic therapy

          -  Have received 4 or more prior doses of rituximab

          -  At least 1 measurable tumor mass (>1.5 cm in the long axis and >1.0 cm in the short
             axis that has not been previously irradiated, or has grown since previous irradiation

          -  No clinically significant 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. Subjects with
             prostate cancer who were treated with definitive radiotherapy and have a serum
             prostate-specific antigen (PSA) <1 ng/mL are not excluded. Subjects are also 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.

          -  Prior treatment with VELCADE® or bendamustine

          -  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

          -  Platelet transfusion within 7 days of Day 1 of Cycle 1 (applies to subjects enrolled
             in the dose escalation phase only. This does not apply to subjects enrolled in phase 2
             of the study).

          -  Ongoing therapy with corticosteroids. Prednisone ≤15 mg per day or its equivalent is
             allowed.