Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL

PHASE2CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

July 31, 2007

Study Completion Date

July 31, 2007

Conditions
Lymphoma, Low-Grade
Interventions
DRUG

Fludarabine Phosphate (Fludara)

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)

DRUG

Rituximab

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)

Trial Locations (8)

464-8681

Nagoya

466-0814

Nagoya

277-8577

Kashiwa-shi

259-1193

Isehara-shi

602-0841

Kyoto

980-0872

Sendai

431-3192

Hamamatsu

104-0045

Chuo-ku

All Listed Sponsors
lead

Genzyme, a Sanofi Company

INDUSTRY

NCT00311129 - Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL | Biotech Hunter | Biotech Hunter