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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00311129
First received: March 31, 2006
Last updated: December 2, 2013
Last verified: December 2013
  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 Sanofi:

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, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Additional Information:
No publications provided by Sanofi

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: December 2, 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 April 20, 2014