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

December 2, 2013 updated by: Genzyme, a Sanofi Company

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Cagliari, Italy, 09121
      • Firenze, Italy, 50139
      • Napoli, Italy, 80131
      • Ravenna, Italy, 48100
      • Roma, Italy, 00161
      • Siena, Italy, 53100
      • Udine, Italy, 33100
    • BO
      • Bologna, BO, Italy, 40138
    • FC
      • Cesena, FC, Italy, 47023
      • Forlì, FC, Italy, 47100
    • GE
      • Genova, GE, Italy, 16132
    • RM
      • Roma, RM, Italy, 00144
      • Roma, RM, Italy, 00168
    • RN
      • Rimini, RN, Italy, 47900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete response rate
Time Frame: Measurement of outcome 4 to 6 weeks after EOT
Measurement of outcome 4 to 6 weeks after EOT

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall response rate, molecular response rate, toxicity profile, patients quality of life
Time Frame: Measurement of outcome 4 to 6 weeks after EOT
Measurement of outcome 4 to 6 weeks after EOT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

December 2, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 308580
  • 91381

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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