Induction Treatment With Anti-CD20 Plus Hyper-CVAD and Methotrexate/Cytarabine Followed by Consolidation Treatment With Y90 Ibritumomab-Tiuxetan in Patients With Mantle Cell Lymphoma
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of the treatment, recording the adverse events throughout the treatment.
Reyes Arranz, MD, PhD
Hospital La Princesa
Spain: Spanish Agency of Medicines