Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL
This study has been completed.
Sponsor:
Genzyme
Information provided by:
Genzyme
ClinicalTrials.gov Identifier:
NCT00311129
First received: March 31, 2006
Last updated: March 6, 2013
Last verified: March 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma, Low-Grade |
Drug: Fludarabine Phosphate (Fludara) Drug: Rituximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Genzyme:
Primary Outcome Measures:
- Overall response rate [ Time Frame: The best response until the end of 6th treatment cycle ]
Secondary Outcome Measures:
- CR rate [ Time Frame: CR or CRu until the end of 6th treatment cycles ]
- 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 ]
- Overall survival [ Time Frame: Death, observed until 12 weeks after the completion of the treatment in the last patient ]
| Enrollment: | 41 |
| Study Start Date: | December 2005 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 Name: 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)
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311129
Locations
| Japan | |
| Nagoya-shi, Aichi, Japan, 464-8681 | |
| Nagoya-shi, Aichi, Japan, 466-0814 | |
| Kashiwa-shi, Chiba, Japan, 277-8577 | |
| Isehara-shi, Kanagawa, Japan, 259-1193 | |
| Kyoto-shi, Kyoto, Japan, 602-0841 | |
| Sendai-shi, Miyagi, Japan, 980-0872 | |
| Hamamatsu-shi, Shizuoka, Japan, 431-3192 | |
| Chuo-ku, Tokyo, Japan, 104-0045 | |
Sponsors and Collaborators
Genzyme
Investigators
| Study Director: | Medical Monitor | Genzyme |
More Information
Additional Information:
No publications provided by Genzyme
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medical Monitor, Genzyme |
| ClinicalTrials.gov Identifier: | NCT00311129 History of Changes |
| Other Study ID Numbers: | 309123, 91456 |
| Study First Received: | March 31, 2006 |
| Last Updated: | March 6, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Fludarabine Fludarabine monophosphate Rituximab Vidarabine |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 21, 2013