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

December 30, 2011 updated by: CABYC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28035
        • Hospital Universitario Puerta de Hierro
      • Madrid, Spain, 28006
        • Hospital La Princesa
      • Madrid, Spain, 28006
        • Clinica Ruber
      • Madrid, Spain, 28008
        • Clínica Moncloa
      • Madrid, Spain, 28224
        • Hospital Quirón
      • Murcia, Spain, 30008
        • Hospital Morales Meseguer
      • Salamanca, Spain, 37007
        • Hospital Clínico de Salamanca
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Marques de Valdecilla
    • Cataluña
      • Barcelona, Cataluña, Spain, 08003
        • Hospital Del Mar
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46010
        • Hospital Clinico de Valencia
      • Valencia, Comunidad Valenciana, Spain, 46017
        • Hospital Dr. Peset
    • Galica
      • Santiago de Compostela, Galica, Spain, 15705
        • Hospital Clínico de Santiago de Compostela
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universitaria de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment safety
Time Frame: 36 months
Safety of the treatment, recording the adverse events throughout the treatment.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months
Efficacy based on response rate: overall, partial and complete response.
Time Frame: 36 months
36 months
Progression free, disease free and overall survivals.
Time Frame: 36 months
36 months
Analysis of the significance of the minimal residual disease (MRD) detection.
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CABYC

Collaborators

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Investigators

  • Principal Investigator: Reyes Arranz, MD, PhD, Hospital La Princesa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

July 20, 2007

First Submitted That Met QC Criteria

July 20, 2007

First Posted (ESTIMATE)

July 23, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 2, 2012

Last Update Submitted That Met QC Criteria

December 30, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GELTAMO-LCM-04-02
  • 2005-004400-37 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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