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

NCT ID: NCT00311129

Last Updated: 2013-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2007-07-31

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.

Conditions

Lymphoma, Low-Grade

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Fludarabine Phosphate (Fludara)

Intervention Type: 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)

Arm 2

Group Type: ACTIVE_COMPARATOR

Rituximab

Intervention Type: 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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Other Intervention Names

BAY86-4864

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Genzyme

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

Nagoya, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Kashiwa-shi, Chiba, Japan

Isehara-shi, Kanagawa, Japan

Kyoto, Kyoto, Japan

Sendai, Miyagi, Japan

Hamamatsu, Shizuoka, Japan

Chuo-ku, Tokyo, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 19594547 (View on PubMed)

Other Identifiers

91456

Identifier Type: -

Identifier Source: secondary_id

309123

Identifier Type: -

Identifier Source: org_study_id