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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00185445
First received: September 13, 2005
Last updated: December 2, 2013
Last verified: December 2013
  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: Fludarabine Phosphate (Fludara)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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: 62
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
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 Name: BAY86-4864

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

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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Italy
Bologna, BO, Italy, 40138
Cesena, FC, Italy, 47023
Forlì, FC, Italy, 47100
Genova, GE, Italy, 16132
Roma, RM, Italy, 00144
Roma, RM, Italy, 00168
Rimini, RN, Italy, 47900
Cagliari, Italy, 09121
Firenze, Italy, 50139
Napoli, Italy, 80131
Ravenna, Italy, 48100
Roma, Italy, 00161
Siena, Italy, 53100
Udine, Italy, 33100
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00185445     History of Changes
Other Study ID Numbers: 308580, 91381
Study First Received: September 13, 2005
Last Updated: December 2, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Sanofi:
Non Hodgkin Lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine
Fludarabine phosphate
Mitoxantrone
Vidarabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014