NCT00505232

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_2

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

January 2, 2012

Status Verified

December 1, 2011

Enrollment Period

4.2 years

First QC Date

July 20, 2007

Last Update Submit

December 30, 2011

Conditions

Mantle Cell Lymphoma

Keywords

Y-90 Ibritumomab tiuxetanRituximabHyper-CVADMantle Cell Lymphoma PatientsZevalin(R)

Outcome Measures

Primary Outcomes (1)

  • Treatment safety

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

    36 months

Secondary Outcomes (4)

  • Feasibility of proposed treatment scheme.

    36 months

  • 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

Study Arms (1)

Rituximab-HCVAD,Methotrexate/Cytarabine and Zevalin

EXPERIMENTAL

Induction Treatment (Rituximab-HCVAD and Methotrexate/Cytarabine) followed by Consolidation Treatment (Rituximab and Y-90 Ibritumomab tiuxetan)

Drug: Y-90 Ibritumomab tiuxetan

Interventions

Y-90 Ibritumomab tiuxetanDRUG

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.

Rituximab-HCVAD,Methotrexate/Cytarabine and Zevalin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

Location

Hospital Clínico de Santiago de Compostela

Santiago de Compostela, Galica, 15705, Spain

Location

Clinica Ruber

Madrid, Madrid, 28006, Spain

Location

Hospital La Princesa

Madrid, Madrid, 28006, Spain

Location

Clinica Moncloa

Madrid, Madrid, 28008, Spain

Location

Hospital Ramon y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, Madrid, 28035, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Quiron

Madrid, Madrid, 28224, Spain

Location

Hospital Morales Meseguer

Murcia, Murcia, 30008, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Clínico de Salamanca

Salamanca, Salamanca, 37007, Spain

Location

Hospital Clinico de Valencia

Valencia, Valencia, 46010, Spain

Location

Hospital Dr. Peset

Valencia, Valencia, 46017, Spain

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Reyes Arranz, MD, PhD

    Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2007

First Posted

July 23, 2007

Study Start

January 1, 2006

Primary Completion

March 1, 2010

Study Completion

May 1, 2011

Last Updated

January 2, 2012

Record last verified: 2011-12

Locations

ES(16)