Comparison of Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma or Follicular Grade 3 Lymphoma Who Have Relapsed After Therapy and Are Not Eligible for Stem Cell Transplant
Condition: Diffuse Large B-cell Lymphoma; de Novo DLBCL; DLBCL Transformed From Indolent Lymphoma; Follicular Grade 3 Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Aggression
Intervention: Pixantrone + Rituximab; Gemcitabine + Rituximab
Intervention description: Pixantrone + Rituximab: Rituximab 375 mg/m2 IV on day 1 and pixantrone 50 mg/m2 (equivalent to 85mg/m2 pixantrone dimaleate)IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.; Gemcitabine + Rituximab: Rituximab 375 mg/m2 IV on day 1 and gemcitabine 1000 mg/m2 IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.
Intervention MeSH terms: Rituximab; Gemcitabine; Pixantrone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 312.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: non-hodgkin lymphoma; DLBCL; relapsed; aggressive NHL; Diffuse large B-cell lymphoma; Rituximab; Rituxan; Pixantrone; NHL; non hodgkin's lymphoma; de novo DLBCL; DLBCL transformed from Indolent Lymphoma; Follicular Grade 3 Lymphoma

Summary:

      The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to
      Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma
      (DLBCL), or follicular grade 3 lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of DLBCL (de novo DLBCL, or transformed from indolent lymphoma) or
             follicular grade 3 lymphoma on the basis of tissue biopsy.

          2. Patients with de novo DLBCL must have received 1-3 treatment regimens for DLBCL.
             Patients with follicular grade 3 lymphoma must have received 1-3 treatment regimens
             for follicular lymphoma (any grade). Patients with DLBCL transformed from indolent
             lymphoma must have received at least 1-4 treatment regimens for NHL.

          3. Received rituximab containing a multi-agent therapy for the treatment of NHL.

          4. Not eligible for high-dose chemotherapy and stem cell transplant.

          5. Patients with DLBCL transformed from indolent lymphoma must have had a complete or
             partial response to a therapy for NHL lasting at least 12 weeks.

        Exclusion Criteria:

          1. Primary refractory de novo DLBCL or primary refractory follicular grade 3 lymphoma,
             defined as documented progression within 12 weeks of the last cycle of the first-line
             multi-agent regimen.

          2. Prior treatment with cumulative dose of doxorubicin or equivalent exceeding 450 mg/m2

          3. Any experimental therapy ≤ 28 days prior to randomization

          4. Other malignancy within last 5 years except for the following: curatively treated
             basal cell/squamous cell skin cancer, carcinoma in situ of the cervix, superficial
             transitional cell bladder carcinoma, or in situ ductal carcinoma of the breast after
             complete resection

          5. Any contraindication or known allergy or hypersensitivity to any study drugs

          6. Concomitant therapy with any anticancer agents, immunosuppressive agents, other
             investigational anticancer therapies. Low-dose corticosteroids for the treatment of
             non cancer-related illnesses are permitted.