Full Text View
Tabular View
No Study Results Posted
Related Studies
Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL
This study has been completed.
First Received: March 31, 2006   Last Updated: November 17, 2008   History of Changes
Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00311129
  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
Phase II

MedlinePlus related topics: Lymphoma
Drug Information available for: Fludarabine Fludarabine monophosphate Rituximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Bayer:

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
Arms Assigned Interventions
Arm 1: Experimental Drug: Fludarabine phosphate
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)

Detailed Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

  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

Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Yakuhin Ltd. ( Therapeutic Area Head )
Study ID Numbers: 91456, 309123
Study First Received: March 31, 2006
Last Updated: November 17, 2008
ClinicalTrials.gov Identifier: NCT00311129     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:
Antimetabolites
Vidarabine
Immunoproliferative Disorders
Immunologic Factors
Rituximab
Fludarabine monophosphate
Immunosuppressive Agents
Antiviral Agents
Lymphatic Diseases
Fludarabine
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Vidarabine
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Fludarabine monophosphate
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Fludarabine
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009