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

Lymphoma, Low-Grade Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311129
• Other study ID #: 309123
• Secondary ID: 91456
• Status: Completed
• Phase: Phase 2
• First received: March 31, 2006
• Last updated: December 2, 2013
• Start date: December 2005
• Est. completion date: July 2007

Study information

• Verified date: December 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma, Low-Grade
• Lymphoma, Non-Hodgkin

Intervention

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)
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		The best response until the end of 6th treatment cycle
Secondary	CR rate		CR or CRu until the end of 6th treatment cycles
Secondary	Progression free survival		Progression or death which comes earlier, observed until 12 weeks after the completion of the treatment in the last patient
Secondary	Overall survival		Death, observed until 12 weeks after the completion of the treatment in the last patient

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