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NCT Number: NCT00505232

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

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.

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Key information

Conditions

Mantle Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Y-90 Ibritumomab tiuxetan

Drug

Study Design

The present study will be split into two cohorts:

  • Patients younger than 60 years who will receive 8 chemotherapy cycles
  • 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 outcomes

  1. Treatment safety

    Time frame: 36 months

    Safety of the treatment, recording the adverse events throughout the treatment.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

CABYC

Industry

Collaborators

  • Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Registry information

Official study 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

Acronym: LCM-04-02

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Jul 23, 2007
Registry last updated
Jan 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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