Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL
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
2 other identifiers
interventional
41
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2005
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 31, 2006
CompletedFirst Posted
Study publicly available on registry
April 5, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedDecember 4, 2013
December 1, 2013
1.6 years
March 31, 2006
December 2, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Overall response rate
The best response until the end of 6th treatment cycle
Secondary Outcomes (3)
CR rate
CR or CRu until the end of 6th treatment cycles
Progression free survival
Progression or death which comes earlier, observed until 12 weeks after the completion of the treatment in the last patient
Overall survival
Death, observed until 12 weeks after the completion of the treatment in the last patient
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORInterventions
Injection of rituximab on Day 1 along with 5-consecutive day oral dosing of fludarabine phosphate from Day 1 to Day 5, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD)
Injection of rituximab on Day 1, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Nagoya, Aichi-ken, 464-8681, Japan
Unknown Facility
Nagoya, Aichi-ken, 466-0814, Japan
Unknown Facility
Kashiwa-shi, Chiba, 277-8577, Japan
Unknown Facility
Isehara-shi, Kanagawa, 259-1193, Japan
Unknown Facility
Kyoto, Kyoto, 602-0841, Japan
Unknown Facility
Sendai, Miyagi, 980-0872, Japan
Unknown Facility
Hamamatsu, Shizuoka, 431-3192, Japan
Unknown Facility
Chuo-ku, Tokyo, 104-0045, Japan
Related Publications (1)
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.
PMID: 19594547DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 31, 2006
First Posted
April 5, 2006
Study Start
December 1, 2005
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
December 4, 2013
Record last verified: 2013-12