Status:
UNKNOWN
Interventional Study on Pentostatin, Cyclophosphamide and Rituximab in Indolent B-Cell Non-Hodgkin-Lymphoma (B-NHL)
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
Diakonie Krankenhaus Schwäbisch Hall, Germany
Ludwig-Maximilians - University of Munich
Conditions:
Immunocytoma/Morbus Waldenström
B-Cell Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The combination of Fludarabine and Cyclophosphamide have yielded overall response rates of over 80% in previously untreated patients with indolent Non-Hodgkin-Lymphoma. However, hematotoxicity rates w...
Eligibility Criteria
Inclusion
- confirmed first diagnosis of or relapsed CD20-positive Immunocytoma, B-CLL or other indolent B-NHL
- therapy-requiring CLL defined as: Binet stage C or Binet B combined with occurence of B-symptoms, rapidly progressing disease, risk of organ compression by lymphoma mass
- therapy-requiring Immunocytoma as defined by the Consensus Panel Recommendations from the Second International Workshop on Waldenström´s Macroglobulinemia, 2003)
- age \> 18 years
- anticipated life expectancy \> 6 months
- ECOG 0-3
- no significant comorbidities
- signed informed consent
- efficient method of contraception during time of therapy (men and women)
Exclusion
- age \< 18 years
- CD20 negativity
- significant comorbidities interfering with therapy as required by the protocol
- history of HIV infection or active hepatitis
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT00927797
Start Date
February 1 2005
End Date
January 1 2012
Last Update
June 25 2009
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