Efficacy and Safety Study of Oral Fludarabine Phosphate in Combination With Mitoxantrone as First Line Treatment in Follicular NHL
NCT ID: NCT00185445
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2004-06-30
2006-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Fludarabine Phosphate (Fludara)
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.
Interventions
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Fludarabine Phosphate (Fludara)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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Bologna, BO, Italy
Cesena, FC, Italy
Forlì, FC, Italy
Genova, GE, Italy
Roma, RM, Italy
Roma, RM, Italy
Rimini, RN, Italy
Cagliari, , Italy
Florence, , Italy
Napoli, , Italy
Ravenna, , Italy
Roma, , Italy
Siena, , Italy
Udine, , Italy
Countries
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Other Identifiers
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91381
Identifier Type: -
Identifier Source: secondary_id
308580
Identifier Type: -
Identifier Source: org_study_id