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

Primary Purpose

Lymphoma, Low-Grade

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Fludarabine Phosphate (Fludara)
Rituximab
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Low-Grade

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

CR rate
Progression free survival
Overall survival

Full Information

First Posted
March 31, 2006
Last Updated
December 2, 2013
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00311129
Brief Title
Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL
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 Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Low-Grade

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fludarabine Phosphate (Fludara)
Other Intervention Name(s)
BAY86-4864
Intervention Description
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
Intervention Name(s)
Rituximab
Intervention Description
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)
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
The best response until the end of 6th treatment cycle
Secondary Outcome Measure Information:
Title
CR rate
Time Frame
CR or CRu until the end of 6th treatment cycles
Title
Progression free survival
Time Frame
Progression or death which comes earlier, observed until 12 weeks after the completion of the treatment in the last patient
Title
Overall survival
Time Frame
Death, observed until 12 weeks after the completion of the treatment in the last patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
466-0814
Country
Japan
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
City
Isehara-shi
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-0841
Country
Japan
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-0872
Country
Japan
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
19594547
Citation
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.
Results Reference
derived

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

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