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Clinical Trials/EUCTR2008-008202-52-AT
EUCTR2008-008202-52-AT
Active, not recruiting
Phase 1

DOUBLE BLIND RANDOMIZED PHASE III STUDY OF LENALIDOMIDE (REVLIMID®) MAINTENANCE VERSUS PLACEBO IN RESPONDING ELDERLY PATIENTS WITH DLBCL AND TREATED WITH R-CHOP IN FIRST LINE - REMARC

YSARC0 sites725 target enrollmentAugust 26, 2010
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DrugsREVLIMID 25mgREVLIMID 20mgREVLIMID 15mgREVLIMID 10mgREVLIMID 5mg

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
YSARC
Enrollment
725
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 26, 2010
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
YSARC

Eligibility Criteria

Inclusion Criteria

  • •For patients registered at the time of initial diagnosis:
  • •Patient with histologically proven CD20\+ diffuse large B\-cell lymphoma (DLBCL) (WHO classification 2008\) including clinical subtypes (primitive mediastinal, intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma (Follicular, other..) may also be included. Patients with DLBCL associated with some small cell infiltration in bone marrow may also be included
  • •\- Or CD20\+ B\-cell lymphoma with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma
  • •\- Or CD20\+ Follicular lymphoma grade 3B
  • •\- Or CD20\+ Agressive B\-cell lymphoma unclassifiable
  • •Previously untreated with chemo\- or radiotherapy
  • •For patients registered after response evaluation to first line treatment with R\-CHOP:
  • •Patient with histologically proven CD20\+ diffuse large B\-cell lymphoma (DLBCL) (WHO classification 2008\) including clinical subtypes (primitive mediastinal, intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma (Follicular, other...) may also be included. Patients with DLBCL associated with some small cell infiltration in bone marrow may also be included
  • •\- Or CD20\+ B\-cell lymphoma with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma
  • •\- Or CD20\+ Follicular lymphoma grade 3B

Exclusion Criteria

  • •For all patients:
  • •Any other histological type of lymphoma, Burkitt included.
  • •Any history of treated or non\-treated small B\-cell lymphoma
  • •Central nervous system or meningeal involvement by lymphoma
  • •Contraindication to any drug contained in the chemotherapy regimen For example: cardiac contra\-indication to anthracyclines (alteration of Left Ventricular Function defined by LVEF\<50%) neurological contra\-indication to vincristine (peripheral neuropathy of WHO grade \= 2\).
  • •Myocardial infarction during last 3 months or unstable coronary disease or uncontrolled chronic symptomatic congestive heart insufficiency NYHA III \- IV
  • •Uncontrolled hypertension
  • •Uncontrolled diabetes mellitus as defined by the investigator
  • •Active systemic infection requiring treatment.
  • •Previously known HIV positive serology

Outcomes

Primary Outcomes

Not specified

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