Clinical trial NCT00688883: Fludara (Oral) Phase II Study for Indolent Lymphoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: Fludarabine
Purine analog
Indolent lymphoma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Best overall response rate; Antitumor effect
timeFrame: 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
Secondary outcomes:
measure: CR rate
timeFrame: after last observation of last treatment cycle
measure: Time to treatment failure
timeFrame: after last observation of last treatment cycle
measure: Overall survival
timeFrame: after last observation of last treatment cycle
measure: Adverse events collection
timeFrame: after last observation of last treatment cycle
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
state: Aichi
city: Nagoya-shi
country: Japan
state: Aichi
city: Kashiwa-shi
country: Japan
state: Chiba
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Akashi-shi
country: Japan
state: Hyogo
city: Kagoshima-shi
country: Japan
state: Kagoshima
city: Isehara-shi
country: Japan
state: Kanagawa
city: Kyoto-shi
country: Japan
state: Kyoto
city: Sendai-shi
country: Japan
state: Miyagi
city: Nagasaki-shi
country: Japan
state: Nagasaki
city: Okayama-shi
country: Japan
state: Okayama
city: Moriguchi-shi
country: Japan
state: Osaka
city: Hamamatsu-shi
country: Japan
state: Shizuoka
city: Chuo-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: