Clinical trial NCT00185445: Efficacy and Safety Study of Oral Fludarabine Phosphate in Combination With Mitoxantrone as First Line Treatment in Follicular NHL
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Hodgkin Lymphoma
Keywords: Non Hodgkin Lymphoma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Complete response rate
timeFrame: Measurement of outcome 4 to 6 weeks after EOT
Secondary outcomes:
measure: Overall response rate, molecular response rate, toxicity profile, patients quality of life
timeFrame: Measurement of outcome 4 to 6 weeks after EOT
Other outcomes:
Locations:
city: Bologna
country: Italy
state: BO
city: Cesena
country: Italy
state: FC
city: Forlì
country: Italy
state: FC
city: Genova
country: Italy
state: GE
city: Roma
country: Italy
state: RM
city: Roma
country: Italy
state: RM
city: Rimini
country: Italy
state: RN
city: Cagliari
country: Italy
city: Firenze
country: Italy
city: Napoli
country: Italy
city: Ravenna
country: Italy
city: Roma
country: Italy
city: Siena
country: Italy
city: Udine
country: Italy
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: