Clincosm LogoSign in Get a demo

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

Sponsor
Genzyme, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00185445
Collaborator
(none)
62
Enrollment
14
Locations
1
Arm
28
Duration (Months)
4.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Fludarabine Phosphate (Fludara)
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jun 1, 2004
Actual Primary Completion Date :
Oct 1, 2006
Actual Study Completion Date :
Oct 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

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.
Other Names:
  • BAY86-4864

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Complete response rate [Measurement of outcome 4 to 6 weeks after EOT]

    Secondary Outcome Measures

    1. Overall response rate, molecular response rate, toxicity profile, patients quality of life [Measurement of outcome 4 to 6 weeks after EOT]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bologna BO Italy 40138
    2 Cesena FC Italy 47023
    3 Forlì FC Italy 47100
    4 Genova GE Italy 16132
    5 Roma RM Italy 00144
    6 Roma RM Italy 00168
    7 Rimini RN Italy 47900
    8 Cagliari Italy 09121
    9 Firenze Italy 50139
    10 Napoli Italy 80131
    11 Ravenna Italy 48100
    12 Roma Italy 00161
    13 Siena Italy 53100
    14 Udine Italy 33100

    Sponsors and Collaborators

    • Genzyme, a Sanofi Company

    Investigators

    • Study Director: Medical Monitor, Genzyme, a Sanofi Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genzyme, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT00185445
    Other Study ID Numbers:
    • 308580
    • 91381
    First Posted:
    Sep 16, 2005
    Last Update Posted:
    Dec 4, 2013
    Last Verified:
    Dec 1, 2013
    Keywords provided by Genzyme, a Sanofi Company
    Non Hodgkin Lymphoma
    Additional relevant MeSH terms:
    Lymphoma, Non-Hodgkin
    Fludarabine
    Fludarabine phosphate

    Study Results

    No Results Posted as of Dec 4, 2013