Safety Study to Evaluate Induction and Consolidation Treatment in Patients With Mantle Cell Lymphoma (LCM-04-02)
- Registration Number
- NCT00505232
- Lead Sponsor
- CABYC
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- All histologic MCL subtypes (WHO classification)
- Age between 18 and 70 years old
- Performance status 0 to 2 (ECOG)
- Cardiac ejection fraction >50%
- Adequate organ (hepatic, cardiac and renal) and marrow function: Hb> 10g/dl, neutrophil counts> 1500/ µl, platelet> 100000/ µl. Creatinine < 2,5xULN, bilirubin, AST or ALT<2,5xULN.
- For Y90-ibritumomab tiuxetan administration: Bone Marrow Infiltration by lymphoma cells < than 25% ; platelet count >100,000/µl and neutrophil counts >1500/µl
- Informed consent should be obtained
- Ann Arbor stages I or II without B symptoms or bulky disease (>10 cm).
- Previous chemotherapy or radiotherapy treatment.
- Uncontrolled current illness: Hepatic, renal, cardiovascular, neurological or metabolic illness.
- Symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia.
- HIV, HBV or HCV positive serology.
- Limitation of the patient´s ability to comply with the treatment or follow-up protocol.
- Men and women with reproductive potential who are not using effective contraceptive methods during and at least 12 months after the end of the study
- Acute or chronic active infection.
- Known hypersensitivity to some of the drugs or other related compounds
- No informed consent obtained
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rituximab-HCVAD,Methotrexate/Cytarabine and Zevalin Y-90 Ibritumomab tiuxetan Induction Treatment (Rituximab-HCVAD and Methotrexate/Cytarabine) followed by Consolidation Treatment (Rituximab and Y-90 Ibritumomab tiuxetan)
- Primary Outcome Measures
Name Time Method Treatment safety 36 months Safety of the treatment, recording the adverse events throughout the treatment.
- Secondary Outcome Measures
Name Time Method Feasibility of proposed treatment scheme. 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. 36 months Progression free, disease free and overall survivals. 36 months Analysis of the significance of the minimal residual disease (MRD) detection. 36 months
Trial Locations
- Locations (16)
Clinica Moncloa
🇪🇸Madrid, Spain
Hospital Quiron
🇪🇸Madrid, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Marques de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital del Mar
🇪🇸Barcelona, Cataluña, Spain
Hospital Dr. Peset
🇪🇸Valencia, Comunidad Valenciana, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Clinica Universitaria de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Clinico de Valencia
🇪🇸Valencia, Comunidad Valenciana, Spain
Hospital Clínico de Santiago de Compostela
🇪🇸Santiago de Compostela, Galica, Spain
Clinica Ruber
🇪🇸Madrid, Spain
Hospital La Princesa
🇪🇸Madrid, Spain
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Morales Meseguer
🇪🇸Murcia, Spain
Hospital Clínico de Salamanca
🇪🇸Salamanca, Spain