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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00220285
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 30, 2014
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Lymphoma, B-Cell Lymphoma, Low-Grade Drug: Zevalin (SH L 749 , BAY86-5128) Phase 2

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  (Clinical Trial)
Actual Enrollment : 45 participants
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
Study Start Date : August 2004
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Arm 1 Drug: Zevalin (SH L 749 , BAY86-5128)

Experimental: Arm 2 Drug: Zevalin (SH L 749 , BAY86-5128)

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 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