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

Primary Purpose

Mantle Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Y-90 Ibritumomab tiuxetan
Sponsored by
CABYC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma focused on measuring Y-90 Ibritumomab tiuxetan, Rituximab, Hyper-CVAD, Mantle Cell Lymphoma Patients, Zevalin(R)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Germans Trias i Pujol
  • Hospital Marques de Valdecilla
  • Hospital del Mar
  • Hospital Clinico de Valencia
  • Hospital Dr. Peset
  • Hospital Clínico de Santiago de Compostela
  • Clinica Universitaria de Navarra
  • Clinica Ruber
  • Hospital La Princesa
  • Clinica Moncloa
  • Hospital Ramon y Cajal
  • Hospital Universitario Puerta de Hierro
  • Hospital Universitario La Paz
  • Hospital Quiron
  • Hospital Morales Meseguer
  • Hospital Clínico de Salamanca

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab-HCVAD,Methotrexate/Cytarabine and Zevalin

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Feasibility of proposed treatment scheme.
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.
Progression free, disease free and overall survivals.
Analysis of the significance of the minimal residual disease (MRD) detection.

Full Information

First Posted
July 20, 2007
Last Updated
December 30, 2011
Sponsor
CABYC
Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
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1. Study Identification

Unique Protocol Identification Number
NCT00505232
Brief Title
Safety Study to Evaluate Induction and Consolidation Treatment in Patients With Mantle Cell Lymphoma (LCM-04-02)
Acronym
LCM-04-02
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 Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CABYC
Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma
Keywords
Y-90 Ibritumomab tiuxetan, Rituximab, Hyper-CVAD, Mantle Cell Lymphoma Patients, Zevalin(R)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituximab-HCVAD,Methotrexate/Cytarabine and Zevalin
Arm Type
Experimental
Arm Description
Induction Treatment (Rituximab-HCVAD and Methotrexate/Cytarabine) followed by Consolidation Treatment (Rituximab and Y-90 Ibritumomab tiuxetan)
Intervention Type
Drug
Intervention Name(s)
Y-90 Ibritumomab tiuxetan
Intervention Description
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 Outcome Measure Information:
Title
Treatment safety
Description
Safety of the treatment, recording the adverse events throughout the treatment.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Feasibility of proposed treatment scheme.
Description
Number and percentage of patients susceptible of receiving consolidation treatment after induction chemotherapy, according to inclusion criteria for consolidation with radioinmunotherapy.
Time Frame
36 months
Title
Efficacy based on response rate: overall, partial and complete response.
Time Frame
36 months
Title
Progression free, disease free and overall survivals.
Time Frame
36 months
Title
Analysis of the significance of the minimal residual disease (MRD) detection.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reyes Arranz, MD, PhD
Organizational Affiliation
Hospital La Princesa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Clinico de Valencia
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Dr. Peset
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital Clínico de Santiago de Compostela
City
Santiago de Compostela
State/Province
Galica
ZIP/Postal Code
15705
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Clinica Ruber
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Clinica Moncloa
City
Madrid
ZIP/Postal Code
28008
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Quiron
City
Madrid
ZIP/Postal Code
28224
Country
Spain
Facility Name
Hospital Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Hospital Clínico de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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