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Clinical Trials/ISRCTN46136861
ISRCTN46136861
Completed
Not Applicable

Randomized phase III study of Rituximab with intensified CHOP chemotherapy versus Rituximab with High-Dose Sequential Therapy and Autologous Stem Cell Transplantation in Adult Patients (18-65 years) with Stage II-IV High-intermediate or High Risk DLBC

Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)0 sites250 target enrollmentJanuary 13, 2006
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)
Enrollment
250
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 13, 2006
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients with a confirmed histologic diagnosis of DLBCL according to the WHO classification
  • •2\. Ann Arbor stage II\-IV
  • •3\. High\-intermediate or high risk NHL according to age\-adjusted IPI score (aa IPI \= 2\-3\)
  • •4\. DLBCL must be CD20 positive
  • •5\. Age 18\-65 years inclusive
  • •6\. WHO performance status 7\. Negative pregnancy test (if applicable)
  • •8\. Written informed consent

Exclusion Criteria

  • •1\. Intolerance of exogenous protein administration
  • •2\. Severe cardiac dysfunction (NYHA classification II\-IV) or LVEF \<45%
  • •3\. Significant renal dysfunction (serum creatinine \>/\= 150 mumol/l), unless related to NHL
  • •4\. Significant hepatic dysfunction (total bilirubin \>/\= 30 mumol/l or
  • •transaminases \>/\= 2\.5 times normal level), unless related to NHL
  • •5\. Suspected or documented Central Nervous System involvement by NHL
  • •6\. Testicular DLBCL
  • •7\. Primary mediastinal B cell lymphoma
  • •8\. Patients known to be HIV\-positive
  • •9\. Patients with active, uncontrolled infections

Outcomes

Primary Outcomes

Not specified

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