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

Non Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185445
• Other study ID #: 308580
• Secondary ID: 91381
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: December 2, 2013
• Start date: June 2004
• Est. completion date: October 2006

Study information

• Verified date: December 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• Non Hodgkin Lymphoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate		Measurement of outcome 4 to 6 weeks after EOT	No
Secondary	Overall response rate, molecular response rate, toxicity profile, patients quality of life		Measurement of outcome 4 to 6 weeks after EOT	No

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