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

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

March 31, 2010

Study Completion Date

May 31, 2011

Conditions
Mantle Cell Lymphoma
Interventions
DRUG

Y-90 Ibritumomab tiuxetan

"Study Design~The present study will be split into two cohorts:~1. Patients younger than 60 years who will receive 8 chemotherapy cycles~2. 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."

Trial Locations (16)

15705

Hospital Clínico de Santiago de Compostela, Santiago de Compostela

28006

Clinica Ruber, Madrid

Hospital La Princesa, Madrid

28008

Clinica Moncloa, Madrid

28034

Hospital Ramon y Cajal, Madrid

28035

Hospital Universitario Puerta de Hierro, Madrid

28046

Hospital Universitario La Paz, Madrid

28224

Hospital Quiron, Madrid

30008

Hospital Morales Meseguer, Murcia

31008

Clinica Universitaria de Navarra, Pamplona

37007

Hospital Clínico de Salamanca, Salamanca

39008

Hospital Marques de Valdecilla, Santander

46010

Hospital Clinico de Valencia, Valencia

46017

Hospital Dr. Peset, Valencia

08916

Hospital Germans Trias i Pujol, Badalona

08003

Hospital del Mar, Barcelona

All Listed Sponsors
collaborator

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

OTHER

lead

CABYC

INDUSTRY

NCT00505232 - Safety Study to Evaluate Induction and Consolidation Treatment in Patients With Mantle Cell Lymphoma (LCM-04-02) | Biotech Hunter | Biotech Hunter