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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


Phase 2
20 Years
74 Years
Not Enrolling
Both
Lymphoma, Low-Grade

Thank you

Trial Information

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


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.


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 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response rate

Outcome Time Frame:

The best response until the end of 6th treatment cycle

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

309123

NCT ID:

NCT00311129

Start Date:

December 2005

Completion Date:

July 2007

Related Keywords:

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

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