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

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00185445

Purpose

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	Intervention	Phase
Non Hodgkin Lymphoma	Drug: Oral fludarabine phosphate	Phase II

MedlinePlus related topics: Lymphoma

Drug Information available for: Mitoxantrone hydrochloride Mitoxantrone Fludarabine Fludarabine monophosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Bayer:

Primary Outcome Measures:

Complete response rate [ Time Frame: Measurement of outcome 4 to 6 weeks after EOT ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall response rate, molecular response rate, toxicity profile, patients quality of life [ Time Frame: Measurement of outcome 4 to 6 weeks after EOT ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	June 2004
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Oral fludarabine phosphate All patients will receive fludarabine phosphate 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

Detailed Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 (see section 7.5.3.1.)
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185445

Locations

Italy

Firenze, Italy, 50139

Ravenna, Italy, 48100

Roma, Italy, 00161

Cagliari, Italy, 09121

Udine, Italy, 33100

Napoli, Italy, 80131

Siena, Italy, 53100
Italy, BO

Bologna, BO, Italy, 40138
Italy, FC

Cesena, FC, Italy, 47023

Forlì, FC, Italy, 47100
Italy, GE

Genova, GE, Italy, 16132
Italy, RM

Roma, RM, Italy, 00144

Roma, RM, Italy, 00168
Italy, RN

Rimini, RN, Italy, 47900

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer S.P.A. Italy ( Therapeutic Area Head )
Study ID Numbers:	91381, 308580
Study First Received:	September 13, 2005
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00185445
Health Authority:	Italy: Ethics Committee

Keywords provided by Bayer:

Non Hodgkin Lymphoma

Study placed in the following topic categories:

Lymphatic Diseases
Vidarabine
Immunoproliferative Disorders
Lymphoma, small cleaved-cell, diffuse
Mitoxantrone

Fludarabine
Fludarabine monophosphate
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs

Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009