The Response Study of Yt90-Zevalin in Patients With Diffuse Large B-cell Lymphoma After 6 Cycles of CHOP
Condition: Diffuse Large B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effective of Yt90-Zevalin therapy in patients
      with diffuse large B-cell lymphoma that have achieved at least an unconfirmed partial
      remission after 6 cycles of CHOP therapy.
    

Detailed description: 
      Diffuse large B-cell lymphomas (DLBCL) are the most common lymphoid neoplasm and account for
      30% to 40% of adult non-Hodgkin lymphomas (NHL). DLCBL is a potentially curable disease. The
      ultimate goals of introducing new modality treatments such as monoclonal antibody
      (Ab)-targeted therapy are to increase complete remission (CR) rate and prolong event-free
      survival and overall survival.In phase II trials, it was shown that in DLBL the addition of
      rituximab to CHOP was feasible, with an increase in ORR, including CR and an increase in the
      OS and PFS in patients with DLBL.2 The benefit of R-CHOP was consistent across all subgroups
      of patients tested, including good and poor risks according to IPI and independent of younger
      than 70 years and older than 70 years of age.

      Recently, new radiolabeled monoclonal antibodies have been established in the therapy of
      malignant lymphoma which can induce high remission rates. Radiolabeled antibodies are
      particularly effective as lymphoma cells are highly sensitive to radiation. In addition, the
      local emission of radiolabeled antibodies is able to destroy cells in close proximity to the
      bound antibody (bystander effect) therefore circumventing the problem of limited perfusion of
      bulky or poorly vascularized tumors.Ibritumomab is covalently linked to the tiuxetan chelate
      and radiolabeled with Yt90, producing Yt90-ibritumomab tiuxetan (Yt90-Zevalin). To optimize
      biodistribution, Rituximab is given prior to the radiolabeled antibody.
      Yt90-ibritumomab-tiuxetan-treatment was compared to a standard course of Rituximab. ORR in
      the Yt90-ibritumomab tiuxetan group was significantly higher than ORR in the Rituximab group
      (80% vs. 56% according to International Workshop Response criteria or 73% vs. 47% according
      to protocol-defined evaluation of response).

      Since radioimmunotherapy represents a significant advance over unlabeled immunotherapy for
      the treatment of patients with B-cell non-Hodgkin's lymphoma, it is worthwhile to study the
      consolidation therapy with Yt90-ibritumomab tiuxetan (Yt90-Zevalin) in patients who achieved
      at least unconfirmed partial remission after 6 cycles of CHOP therapy.
    

Intervention name(s): chemotherapy followed by Zevalin
Intervention type(s): Drug
Intervention description(s): 6 cycles of chemotherapy with CHOP (Cyclophosphamide iv 750 mg/m2 over 15-45 minutes; Doxorubicin iv 50 mg/m2 over 5-20 minutes; and Vincristine iv 1.4 mg/m2 over 5-15 minutes on day 1 and oral prednisone 40 mg/m2 on days 1-5 repeated every 21 days), followed by Zevalin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CHOP-Z