Study for Evaluation of Efficacy and Safety of SH L 749 to Indolent B-cell Non-Hodgkin's Lymphoma

December 29, 2014 updated by: Bayer

A Phase II Open-label Study of SH L 749 in Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphomas

The purpose of this study is to investigate the antitumor effect and safety of the product for relapsed or refractory indolent B-cell non-Hodgkin's lymphomas.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

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
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
    • Gunma
      • Maebashi-shi, Gunma, Japan, 371-8511
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 920-8641
    • Kanagawa
      • Isehara-shi, Kanagawa, Japan, 259-1193
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 602-0841
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 980-0872
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
      • Shinjuku-ku, Tokyo, Japan, 160-8582

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:

  • Platelet counts of >/= 100,000/mm3
  • Absolute neutrophil counts of >/= 1,200/mm3
  • Bone marrow involvement < 25%

Exclusion Criteria:

  • Patients who received hematopoietic stem cell transplantation, including bone marrow transplantation, peripheral blood stem cell transplantation, etc.
  • Patients presenting with marked bone marrow hypocellularity (any suspected bone marrow hypocellularity should be confirmed by bone marrow biopsy)
  • Patients with previous myocardial infarction within the past 1 year, with heart disease that requires treatment or with pulmonary dysfunction
  • Patients with serious concomitant diseases (cardiac failure, renal failure, etc.)

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Zevalin (SH L 749 , BAY86-5128)
0,3mCi/kg
Drug: Zevalin (SH L 749 , BAY86-5128)
0,4mCi/kg
Experimental: Arm 2
Drug: Zevalin (SH L 749 , BAY86-5128)
0,3mCi/kg
Drug: Zevalin (SH L 749 , BAY86-5128)
0,4mCi/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best overall response rates (the percentage of patients who achieved PR or better response)
Time Frame: After 9 weeks or 13 weeks
After 9 weeks or 13 weeks
The incidence of critical toxicity
Time Frame: During treatment period
During treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety evaluation
Time Frame: During treatment period
During treatment period
Complete response (CR or CRu) rates
Time Frame: After 9 weeks or 13 weeks
After 9 weeks or 13 weeks
Progression-free survival (PFS)
Time Frame: After end of study
After end of study

Collaborators and Investigators

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

Sponsor

Bayer

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

August 1, 2004

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

September 21, 2005

First Submitted That Met QC Criteria

September 21, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91102
  • 305618

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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