Efficacy and Safety Study of Oral Fludarabine Phosphate in Combination With Mitoxantrone as First Line Treatment in Follicular NHL

Study Overview
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Brief Summary
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The purpose of the study is to demonstrate that oral fludarabine phosphate is comparable to i.v. formulation used in combination with mitoxantrone in terms of efficacy, safety and risk/benefit profile

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 Phase II Study to Evaluate the Efficacy and Safety of Oral Fludarabine Phosphate in Combination With Mitoxantrone as First Line Treatment in Follicular NHL

Conditions
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Non Hodgkin 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: Indolent B-cell follicular non-Hodgkin's lymphoma (grade I-II according to REAL classification) Stage II to IV according to Ann Arbor staging system WHO performance status grade 0, 1 or 2 and life expectancy of greater than 6 months Exclusion Criteria: Patients who have received any previous treatment for follicular NHL Patients with severe or life-threatening cardiac, pulmonary, neurological, psychiatric or metabolic disease Pregnant and lactating women Women of childbearing potential, and all men, not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy Laboratory screens positive for Hepatitis B, C or HIV infections Patients with autoimmune thrombocytopenia or hemolytic anemia with clinical evidence. NB. A positive Coombs test alone (with no clinical evidence of hemolysis) would not preclude entry in the study. Histological transformation to aggressive B-cell lymphoma Patients with prior malignancies except non melanoma skin tumors or stage 0 (in situ) cervical carcinoma Impairment of hepatic function unless disease related indicated by bilirubin, ASAT, ALAT or gamma-GT raised 2 times above the upper limit of the local laboratory range Impairment of renal function indicated by serum creatinine < 30 ml/min Patients who require systemic long-term therapy with glucocorticoids Participation at the same time in another study in which investigational drugs are used Patients unable to regularly attend outpatient clinic for treatment and assessments Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent Patients with active infection

Ages Eligible for Study
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Minimum Age: 18 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>* All patients will receive fludarabine phosphate orally for 3 consecutive days per cycle and mitoxantrone on day 1. Each patient will receive up to six treatment cycles. Treatment cycles will be given at 4 weeks intervals.<br>* Other names: BAY86-4864;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate |  | Measurement of outcome 4 to 6 weeks after EOT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate, molecular response rate, toxicity profile, patients quality of life |  | Measurement of outcome 4 to 6 weeks after EOT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Hodgkin Lymphoma