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

Conditions

• Lymphoma, Low-Grade

Eligibility Criteria

Sex

ALL

Age

20 Years - 74 Years

Healthy Volunteers

Not accepted

Interventions

• Fludarabine Phosphate (Fludara) — DRUG
  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)
• Rituximab — DRUG
  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)

Study Details

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.

Key Dates

Start date

Dec 31, 2005

Status verified

Dec 2013

Primary completion

Jul 31, 2007

Completion

Jul 31, 2007

Study Design

Enrollment

41 participants (actual)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1
• Active Comparator: Arm 2

Primary Outcome Measure

Overall response rate [ Time Frame: The best response until the end of 6th treatment cycle ]