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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non Hodgkin Lymphoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate

Outcome Time Frame:

Measurement of outcome 4 to 6 weeks after EOT

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

Italy: Ethics Committee

Study ID:

308580

NCT ID:

NCT00185445

Start Date:

June 2004

Completion Date:

October 2006

Related Keywords:

  • Non Hodgkin Lymphoma
  • Non Hodgkin Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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