NCT00185445

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2004

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

December 4, 2013

Status Verified

December 1, 2013

Enrollment Period

2.3 years

First QC Date

September 13, 2005

Last Update Submit

December 2, 2013

Conditions

Non Hodgkin Lymphoma

Keywords

Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Complete response rate

    Measurement of outcome 4 to 6 weeks after EOT

Secondary Outcomes (1)

  • Overall response rate, molecular response rate, toxicity profile, patients quality of life

    Measurement of outcome 4 to 6 weeks after EOT

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Fludarabine Phosphate (Fludara)

Interventions

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.

Also known as: BAY86-4864
Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Bologna, BO, 40138, Italy

Location

Unknown Facility

Cesena, FC, 47023, Italy

Location

Unknown Facility

Forlì, FC, 47100, Italy

Location

Unknown Facility

Genova, GE, 16132, Italy

Location

Unknown Facility

Roma, RM, 00144, Italy

Location

Unknown Facility

Roma, RM, 00168, Italy

Location

Unknown Facility

Rimini, RN, 47900, Italy

Location

Unknown Facility

Cagliari, 09121, Italy

Location

Unknown Facility

Florence, 50139, Italy

Location

Unknown Facility

Napoli, 80131, Italy

Location

Unknown Facility

Ravenna, 48100, Italy

Location

Unknown Facility

Roma, 00161, Italy

Location

Unknown Facility

Siena, 53100, Italy

Location

Unknown Facility

Udine, 33100, Italy

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

fludarabine phosphate

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

June 1, 2004

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

December 4, 2013

Record last verified: 2013-12

Locations

IT(14)