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Clinical Trials/ISRCTN81133184
ISRCTN81133184
Completed
Phase 2

The addition of Rituximab to Fludarabine and Cyclophosphamide chemotherapy results in a significant improvement in overall survival in patients with newly diagnosed mantle cell lymphoma

niversity College London (UK)0 sites151 target enrollmentSeptember 12, 2003
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity College London (UK)
Enrollment
151
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 12, 2003
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity College London (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. Age 18 years or older
  • •2\. Proven mantle cell lymphoma
  • •3\. Previously untreated disease at any stage requiring therapy
  • •4\. No previous chemotherapy
  • •5\. Life expectancy of at least 3 months
  • •6\. Signed and dated informed consent

Exclusion Criteria

  • •1\. Known serological positivity for hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
  • •2\. Pregnant or breast feeding
  • •3\. Concomitant uncontrolled serious medical conditions
  • •4\. Severe renal or hepatic impairment not related to lymphoma
  • •5\. Known hypersensitivity to murine proteins
  • •6\. Previous malignancy in the last 5 years (except non\-melanomatous skin tumours and carcinoma in situ of the cervix)
  • •7\. Psychological illness or condition that prevents adequate trial compliance

Outcomes

Primary Outcomes

Not specified

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