Fludara (Oral) Phase II Study for Indolent Lymphoma

Genzyme

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Drug: Fludarabine Phosphate (Fludara)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00688883

91101

305621

Details and patient eligibility

About

To assess the antitumor effect and safety of Fludara in patients with indolent lymphoma.

Full 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, Germany.

Enrollment: 52 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Fludarabine Phosphate (Fludara)