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

December 2, 2013 updated by: Genzyme, a Sanofi Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Nagoya-shi, Aichi, Japan, 464-8681
      • Nagoya-shi, Aichi, Japan, 466-0814
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
    • Kanagawa
      • Isehara-shi, Kanagawa, Japan, 259-1193
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 602-0841
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 980-0872
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan, 431-3192
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate
Time Frame: The best response until the end of 6th treatment cycle
The best response until the end of 6th treatment cycle

Secondary Outcome Measures

Outcome Measure
Time Frame
CR rate
Time Frame: CR or CRu until the end of 6th treatment cycles
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
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
Death, observed until 12 weeks after the completion of the treatment in the last patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (ACTUAL)

July 1, 2007

Study Completion (ACTUAL)

July 1, 2007

Study Registration Dates

First Submitted

March 31, 2006

First Submitted That Met QC Criteria

March 31, 2006

First Posted (ESTIMATE)

April 5, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

December 4, 2013

Last Update Submitted That Met QC Criteria

December 2, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 309123
  • 91456

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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