Safety Study to Evaluate Induction and Consolidation Treatment in Patients With Mantle Cell Lymphoma (LCM-04-02)
Condition: Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Mantle Cell Lymphoma (MCL) is a malignancy with a poor response to treatment and with a
      median survival of 2- 4 years since diagnosis. Although histology is similar to that of an
      indolent lymphoma, MCL is currently considered an aggressive tumour. Few prospective
      therapeutic trials have been reported in MCL, and results are difficult to interpret due to
      treatment heterogeneity. It is known that standard chemotherapy for other clinically
      aggressive lymphomas yields poor results. Recently, better results have been communicated
      with intense induction chemotherapy treatments or consolidating the response with high dose
      chemotherapy with stem cell support. Keeping in mind these considerations, we will use and
      intensive induction treatment with Hyper-CVAD/MTX-AraC associated with anti-CD20 in order to
      increase the overall response rate followed by consolidation treatment with Ibritumomab
      -tiuxetan (Zevalin) with the aim of eradicate the minimal residual disease, responsible of
      relapse.
    

Detailed description: 
      Study Design:

        -  The Patients will receive 6 cycles of induction chemotherapy as follows: Anti-CD20/Hyper
           -CVAD chemotherapy will be alternated with anti-CD20 +MTX/Ara-C chemotherapy. After 4
           cycles (2 x2), response will be evaluated. If response (complete or partial) is
           observed, 2 additional cycles will be administrated. If less than a partial response is
           observed, the patient will be out of the study.

        -  Consolidation treatment will be a single dose of Y90Ibritumomab -Tiuxetan (Zevalin) will
           be administered after 12 weeks after completion of induction chemotherapy. The initial
           dose of Zevalin will be 0.3 mCi/kg, to be further escalated to 0.4 mCi/Kg if
           unacceptable toxicity does not occur.
    

Intervention name(s): Y-90 Ibritumomab tiuxetan
Intervention type(s): Drug
Intervention description(s): Study Design
The present study will be split into two cohorts:
Patients younger than 60 years who will receive 8 chemotherapy cycles
Patients older than 60 years who will receive 6 chemotherapy cycles
The induction schema summarises as follows :
Anti-CD20/Hyper -CVAD chemotherapy will be alternated with anti-CD20 +MTX/Ara-C chemotherapy twice. Afterward, response will be evaluated, followed by, either, four cycles further patients younger than 60 years who will obtain a CR or PR, or 2 cycles patients older than 60 y. (see figure 1 and flow chart).
Consolidation treatment will consist in a single dose of Y90-Ibritumomab -Tiuxetan (Zevalin) [0.4 mCi/Kg b.w or 0.3 mCi/kg if platelets < 100,000/µl] will be administered 8 to 12 weeks after last chemotherapy.
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Y-90 Ibritumomab tiuxetan; Rituximab; Hyper-CVAD; Mantle Cell Lymphoma Patients; Zevalin(R)