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A Multicenter, Open Study to Assess the Antitumor Effect and Safety of Oral Fludarabine Phosphate (Fludara (SH T 586): 40 mg/m2/Day) Administered in 3 - 6 Treatment Cycles (1 Treatment Cycle: 5-consecutive Day Dosing, Followed by a Observation Period of 23 Days) in Patients With Indolent Lymphoma


Phase 2
20 Years
74 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Multicenter, Open Study to Assess the Antitumor Effect and Safety of Oral Fludarabine Phosphate (Fludara (SH T 586): 40 mg/m2/Day) Administered in 3 - 6 Treatment Cycles (1 Treatment Cycle: 5-consecutive Day Dosing, Followed by a Observation Period of 23 Days) in Patients With Indolent Lymphoma


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:



- Patients with histologically or cytologically confirmed indolent lymphoma (including
mantle cell lymphoma)

- Patients with measurable lesions (major axis > 1.5 cm by CT)

- Patients who failed to have PR to previous chemotherapies or antibody therapies.
Patients with subsequent relapse after a previously attained CR or with subsequent
recurrence after a previously attained PR

- Patients who have not received chemotherapies, antibody therapies or radiotherapies
for more than 4 weeks (more than 3 months in the case of the antibody therapies)

- Patients who have PS Grade 0 to 2 in the criteria of ECOG

- Patients with adequately maintained organ functions

Exclusion Criteria:

- Patients with infectious disease, serious complications, serious gastrointestinal
symptoms, serious bleeding tendency (DIC), CNS metastases, fever more than 38 degrees
Celsius, interstitial pneumonia or pulmonary fibrosis, active other malignancies,
AIHA or the history of allergies to similar purine analogs

- Patients who are positive for HBs antigen, HCV antibody or HIV antibody

- Patients who received G-CSF or blood transfusion within 1 week before the screening
test

- Patients who had ever received previous therapy with fludarabine phosphate injection
(Fludara), pentostatin (Coforin), cladribine (Leustatin) or SH T 586

- Patients who are pregnant, of childbearing potential, lactating, or who do not agree
to practice contraception

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:

Best overall response rate; Antitumor effect

Outcome Time Frame:

at screening and re-evaluation, at 4th week or at the time of discontinuation of treatment cycles 1, 3 and 6, and at 12th week after last observation of last treatment cycle

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

305621

NCT ID:

NCT00688883

Start Date:

February 2003

Completion Date:

August 2004

Related Keywords:

  • Lymphoma
  • Fludarabine
  • Purine analog
  • Indolent lymphoma
  • Lymphoma

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