Fludara (Oral) Phase II Study for Indolent Lymphoma

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688883
• Other study ID #: 305621
• Secondary ID: 91101
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2008
• Last updated: December 2, 2013
• Start date: February 2003
• Est. completion date: August 2004

Study information

• Verified date: December 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

To assess the antitumor effect and safety of Fludara in patients with indolent lymphoma.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• Fludarabine Phosphate (Fludara)
Patients received Fludarabine Phosphate orally for 5 consecutive days, followed by a 23-day observation period. Setting this as 1 treatment cycle, 6 cycles will be given.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best overall response rate; Antitumor effect		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	No
Secondary	CR rate		after last observation of last treatment cycle	No
Secondary	Time to treatment failure		after last observation of last treatment cycle	No
Secondary	Overall survival		after last observation of last treatment cycle	No
Secondary	Adverse events collection		after last observation of last treatment cycle	Yes

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