Status:
COMPLETED
Fludara (Oral) Phase II Study for Indolent Lymphoma
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Lymphoma
Eligibility:
All Genders
20-74 years
Phase:
PHASE2
Brief Summary
To assess the antitumor effect and safety of Fludara in patients with indolent lymphoma.
Detailed Description
As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG...
Eligibility Criteria
Inclusion
- Patients with histologically or cytologically confirmed indolent lymphoma (including mantle cell lymphoma)
- Patients with measurable lesions (major axis \> 1.5 cm by CT)
- Patients who failed to have PR to previous chemotherapies or antibody therapies. Patients with subsequent relapse after a previously attained CR or with subsequent recurrence after a previously attained PR
- Patients who have not received chemotherapies, antibody therapies or radiotherapies for more than 4 weeks (more than 3 months in the case of the antibody therapies)
- Patients who have PS Grade 0 to 2 in the criteria of ECOG
- Patients with adequately maintained organ functions
Exclusion
- Patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency (DIC), CNS metastases, fever more than 38 degrees Celsius, interstitial pneumonia or pulmonary fibrosis, active other malignancies, AIHA or the history of allergies to similar purine analogs
- Patients who are positive for HBs antigen, HCV antibody or HIV antibody
- Patients who received G-CSF or blood transfusion within 1 week before the screening test
- Patients who had ever received previous therapy with fludarabine phosphate injection (Fludara), pentostatin (Coforin), cladribine (Leustatin) or SH T 586
- Patients who are pregnant, of childbearing potential, lactating, or who do not agree to practice contraception
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00688883
Start Date
February 1 2003
End Date
August 1 2004
Last Update
December 4 2013
Active Locations (17)
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1
Nagoya, Aichi-ken, Japan, 464-8681
2
Nagoya, Aichi-ken, Japan, 466-8560
3
Kashiwa-shi, Chiba, Japan, 277-8577
4
Fukuoka, Fukuoka, Japan, 812-0033