Study for Evaluation of Efficacy and Safety of SH L 749 to Indolent B-cell Non-Hodgkin's Lymphoma
NCT ID: NCT00220285
Last Updated: 2014-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
45 participants
INTERVENTIONAL
2004-08-31
2005-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Zevalin (SH L 749 , BAY86-5128)
0,3mCi/kg
Arm 2
Zevalin (SH L 749 , BAY86-5128)
0,4mCi/kg
Interventions
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Zevalin (SH L 749 , BAY86-5128)
0,3mCi/kg
Zevalin (SH L 749 , BAY86-5128)
0,4mCi/kg
Eligibility Criteria
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Inclusion Criteria
* Absolute neutrophil counts of \>/= 1,200/mm3
* Bone marrow involvement \< 25%
Exclusion Criteria
* 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.)
20 Years
74 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer Yakuhin Ltd.
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Nagoya, Aichi-ken, Japan
Kashiwa-shi, Chiba, Japan
Maebashi, Gunma, Japan
Kanazawa, Ishikawa-ken, Japan
Isehara-shi, Kanagawa, Japan
Kyoto, Kyoto, Japan
Sendai, Miyagi, Japan
Chuo-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Countries
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References
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Tobinai K, Watanabe T, Ogura M, Morishima Y, Hotta T, Ishizawa K, Itoh K, Okamoto S, Taniwaki M, Tsukamoto N, Okumura H, Terauchi T, Nawano S, Matsusako M, Matsuno Y, Nakamura S, Mori S, Ohashi Y, Hayashi M, Endo K. Japanese phase II study of 90Y-ibritumomab tiuxetan in patients with relapsed or refractory indolent B-cell lymphoma. Cancer Sci. 2009 Jan;100(1):158-64. doi: 10.1111/j.1349-7006.2008.00999.x. Epub 2008 Oct 24.
Other Identifiers
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305618
Identifier Type: -
Identifier Source: secondary_id
91102
Identifier Type: -
Identifier Source: org_study_id