Clinical trial NCT00311129: Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL
Official title: A Multicenter Study to Assess the Antitumor Effect and Safety of Fludarabine Phosphate Tablet (SH T 586) in Combination With Rituximab Administered in 6 Treatment Cycles (1 Treatment Cycle: Rituximab 375 mg/m2 iv on Day 1 Along With 5-Consecutive Day Oral Dosing of SH T 586 40 mg/m2/Day From Day 1 to Day 5, Followed by an Observation Period of 23 Days) in Patients With Indolent Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Low-Grade
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-04-05
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the antitumor effect and safety of fludarabine phosphate tablet in combination with rituximab in patient 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 CD 20 positive, relapsed/refractory indolent lymphoma. (Regimens of prior chemotherapy are limited to 2; prior rituximab treatments up to 16 times are allowed.)
* Patients with measurable lesions (\> 1.5 cm).
* Patients who have not received any treatment for more than 4 weeks after completing previous therapies (6 months in the case of antibody therapies).
* ECOG performance status: 0 - 1
* Patients with adequately maintained organ functions.

Exclusion Criteria:

* Patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency, serious CNS symptoms, fever \</=38 °C, interstitial pneumonia or pulmonary fibrosis, active other malignancies, autoimmune hemolytic anemia or the history of the disease, or glaucoma.
* Patients who are positive for HBs antigen, HCV antibody, or HIV antibody.
* Patients who received G-CSF or transfusion within 1 week before the registration.
* Patients with the history of allergies to purine nucleoside analogue.
* Patients who experienced serious hypersensitivity or anaphylaxis to rituximab or mouse protein-derived products.
* Patients who had ever received prior therapy with fludarabine phosphate injection, pentostatin, cladribine, SH T 586, blood stem cell transplant, or monoclonal antibody therapy other than rituximab to NHL (including radioimmunotherapy).
* Patients who had progressive disease within 6 months of receiving therapy including rituximab.
* Women who are pregnant, of childbearing potential, or lactating.
* Patients who do not agree to practice contraception.

Primary outcomes:
measure: Overall response rate
timeFrame: The best response until the end of 6th treatment cycle
Secondary outcomes:
measure: CR rate
timeFrame: CR or CRu until the end of 6th treatment cycles
measure: Progression free survival
timeFrame: Progression or death which comes earlier, observed until 12 weeks after the completion of the treatment in the last patient
measure: Overall survival
timeFrame: Death, observed until 12 weeks after the completion of the treatment in the last patient
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: Isehara-shi
country: Japan
state: Kanagawa
city: Kyoto-shi
country: Japan
state: Kyoto
city: Sendai-shi
country: Japan
state: Miyagi
city: Hamamatsu-shi
country: Japan
state: Shizuoka
city: Chuo-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Tobinai K, Ishizawa K, Ogura M, Itoh K, Morishima Y, Ando K, Taniwaki M, Watanabe T, Yamamoto J, Uchida T, Nakata M, Terauchi T, Nawano S, Matsusako M, Hayashi M, Hotta T. Phase II study of oral fludarabine in combination with rituximab for relapsed indolent B-cell non-Hodgkin lymphoma. Cancer Sci. 2009 Oct;100(10):1951-6. doi: 10.1111/j.1349-7006.2009.01247.x. Epub 2009 Jun 17.