Skip to main content
OpenTrials
Completed

NCT Number: NCT00185445

Efficacy and Safety Study 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non Hodgkin Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bologna, BO, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fludarabine Phosphate (Fludara)

Drug

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

Primary outcomes

  1. Complete response rate

    Time frame: Measurement of outcome 4 to 6 weeks after EOT

Secondary outcomes

  1. Overall response rate, molecular response rate, toxicity profile, patients quality of life

    Time frame: Measurement of outcome 4 to 6 weeks after EOT

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.