Clinical Trial: Safety Study to Evaluate Induction and Consolidation Treatment in Patients With Mantle Cell Lymphoma (LCM-04-02)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Induction Treatment With Anti-CD20 Plus Hyper-CVAD and Methotrexate/Cytarabine Followed by Consolidation Treatment With Y90 Ibritumomab-Tiuxetan in Patients With Mantle Cell Lymp

Brief 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 Summary:

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.

Sponsor: CABYC

Current Primary Outcome: Treatment safety [ Time Frame: 36 months ]

Safety of the treatment, recording the adverse events throughout the treatment.


Original Primary Outcome: Primary Efficacy Variable(s) Overall response rate (including complete and partial responses). [ Time Frame: 36 months ]

Current Secondary Outcome:

  • Feasibility of proposed treatment scheme. [ Time Frame: 36 months ]
    Number and percentage of patients susceptible of receiving consolidation treatment after induction chemotherapy, according to inclusion criteria for consolidation with radioinmunotherapy.
  • Efficacy based on response rate: overall, partial and complete response. [ Time Frame: 36 months ]
  • Progression free, disease free and overall survivals. [ Time Frame: 36 months ]
  • Analysis of the significance of the minimal residual disease (MRD) detection. [ Time Frame: 36 months ]


Original Secondary Outcome: Secondary Efficacy Variable Duration of response and time to progression will also be followed as secondary study objectives. Safety Variable All adverse events during the treatment period, as well as secondary malignancies in the follow up period [ Time Frame: 36 months ]

Information By: CABYC

Dates:
Date Received: July 20, 2007
Date Started: January 2006
Date Completion:
Last Updated: December 30, 2011
Last Verified: December 2011