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

This study has been completed.
Information provided by:
Bayer Identifier:
First received: September 21, 2005
Last updated: December 29, 2014
Last verified: December 2014
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.

Condition Intervention Phase
Non-Hodgkin's Lymphoma Lymphoma, B-Cell Lymphoma, Low-Grade Drug: Zevalin (SH L 749 , BAY86-5128) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open-label Study of SH L 749 in Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphomas

Resource links provided by NLM:

Further study details as provided by Bayer:

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

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

Enrollment: 45
Study Start Date: August 2004
Study Completion Date: October 2005
Arms Assigned Interventions
Experimental: Arm 1 Drug: Zevalin (SH L 749 , BAY86-5128)
Experimental: Arm 2 Drug: Zevalin (SH L 749 , BAY86-5128)

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.

Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00220285

Nagoya-shi, Aichi, Japan, 464-8681
Kashiwa-shi, Chiba, Japan, 277-8577
Maebashi-shi, Gunma, Japan, 371-8511
Kanazawa-shi, Ishikawa, Japan, 920-8641
Isehara-shi, Kanagawa, Japan, 259-1193
Kyoto-shi, Kyoto, Japan, 602-0841
Sendai-shi, Miyagi, Japan, 980-0872
Chuo-ku, Tokyo, Japan, 104-0045
Shinjuku-ku, Tokyo, Japan, 160-8582
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Therapeutic Area Head, Bayer Yakuhin Ltd. Identifier: NCT00220285     History of Changes
Other Study ID Numbers: 91102
Study First Received: September 21, 2005
Last Updated: December 29, 2014

Keywords provided by Bayer:

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on September 20, 2017