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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00505232
Recruitment Status : Completed
First Posted : July 23, 2007
Last Update Posted : January 2, 2012
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Mantle Cell Lymphoma Drug: Y-90 Ibritumomab tiuxetan Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Lymphoma
Study Start Date : January 2006
Actual Primary Completion Date : March 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Rituximab-HCVAD,Methotrexate/Cytarabine and Zevalin
Induction Treatment (Rituximab-HCVAD and Methotrexate/Cytarabine) followed by Consolidation Treatment (Rituximab and Y-90 Ibritumomab tiuxetan)
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.

Primary Outcome Measures :
  1. Treatment safety [ Time Frame: 36 months ]
    Safety of the treatment, recording the adverse events throughout the treatment.

Secondary Outcome Measures :
  1. 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.

  2. Efficacy based on response rate: overall, partial and complete response. [ Time Frame: 36 months ]
  3. Progression free, disease free and overall survivals. [ Time Frame: 36 months ]
  4. Analysis of the significance of the minimal residual disease (MRD) detection. [ Time Frame: 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00505232

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Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Hospital del Mar
Barcelona, Cataluña, Spain, 08003
Hospital Clinico de Valencia
Valencia, Comunidad Valenciana, Spain, 46010
Hospital Dr. Peset
Valencia, Comunidad Valenciana, Spain, 46017
Hospital Clínico de Santiago de Compostela
Santiago de Compostela, Galica, Spain, 15705
Clinica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008
Clinica Ruber
Madrid, Spain, 28006
Hospital La Princesa
Madrid, Spain, 28006
Clinica Moncloa
Madrid, Spain, 28008
Hospital Ramon y Cajal
Madrid, Spain, 28034
Hospital Universitario Puerta de Hierro
Madrid, Spain, 28035
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Quiron
Madrid, Spain, 28224
Hospital Morales Meseguer
Murcia, Spain, 30008
Hospital Clínico de Salamanca
Salamanca, Spain, 37007
Sponsors and Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
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Principal Investigator: Reyes Arranz, MD, PhD Hospital La Princesa
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Responsible Party: CABYC Identifier: NCT00505232    
Other Study ID Numbers: GELTAMO-LCM-04-02
2005-004400-37 ( EudraCT Number )
First Posted: July 23, 2007    Key Record Dates
Last Update Posted: January 2, 2012
Last Verified: December 2011
Keywords provided by CABYC:
Y-90 Ibritumomab tiuxetan
Mantle Cell Lymphoma Patients
Additional relevant MeSH terms:
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Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs