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

Sponsor

Genzyme, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00311129

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

5.1

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Low-Grade	Drug: Fludarabine Phosphate (Fludara) Drug: Rituximab	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2005

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	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) Other Names: BAY86-4864
Active Comparator: Arm 2	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)

Arm

Intervention/Treatment

Experimental: Arm 1

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)

Other Names:

BAY86-4864

Active Comparator: Arm 2

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)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Nagoya-shi	Aichi	Japan	464-8681
2	Nagoya-shi	Aichi	Japan	466-0814
3	Kashiwa-shi	Chiba	Japan	277-8577
4	Isehara-shi	Kanagawa	Japan	259-1193
5	Kyoto-shi	Kyoto	Japan	602-0841
6	Sendai-shi	Miyagi	Japan	980-0872
7	Hamamatsu-shi	Shizuoka	Japan	431-3192
8	Chuo-ku	Tokyo	Japan	104-0045