Fludara (Oral) Phase II Study for Indolent Lymphoma

Study Overview
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Brief Summary
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To assess the antitumor effect and safety of Fludara in patients with indolent lymphoma.

Detailed Description
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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.

Official Title
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A Multicenter, Open Study to Assess the Antitumor Effect and Safety of Oral Fludarabine Phosphate (Fludara (SH T 586): 40 mg/m2/Day) Administered in 3 - 6 Treatment Cycles (1 Treatment Cycle: 5-consecutive Day Dosing, Followed by a Observation Period of 23 Days) in Patients With Indolent Lymphoma

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: Fludarabine Phosphate (Fludara)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Fludarabine Phosphate (Fludara)<br>* Patients received Fludarabine Phosphate orally for 5 consecutive days, followed by a 23-day observation period. Setting this as 1 treatment cycle, 6 cycles will be given.<br>* Other names: BAY86-4864;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best overall response rate; Antitumor effect |  | at screening and re-evaluation, at 4th week or at the time of discontinuation of treatment cycles 1, 3 and 6, and at 12th week after last observation of last treatment cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CR rate |  | after last observation of last treatment cycle | 
| Time to treatment failure |  | after last observation of last treatment cycle | 
| Overall survival |  | after last observation of last treatment cycle | 
| Adverse events collection |  | after last observation of last treatment cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fludarabine, Purine analog, Indolent lymphoma