Status:
COMPLETED
Study for Evaluation of Efficacy and Safety of SH L 749 to Indolent B-cell Non-Hodgkin's Lymphoma
Lead Sponsor:
Bayer
Conditions:
Non-Hodgkin's Lymphoma
Lymphoma, B-Cell
Eligibility:
All Genders
20-74 years
Phase:
PHASE2
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.
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.
Eligibility Criteria
Inclusion
- Platelet counts of \>/= 100,000/mm3
- Absolute neutrophil counts of \>/= 1,200/mm3
- Bone marrow involvement \< 25%
Exclusion
- 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.)
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00220285
Start Date
August 1 2004
End Date
October 1 2005
Last Update
December 30 2014
Active Locations (9)
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1
Nagoya, Aichi-ken, Japan, 464-8681
2
Kashiwa-shi, Chiba, Japan, 277-8577
3
Maebashi, Gunma, Japan, 371-8511
4
Kanazawa, Ishikawa-ken, Japan, 920-8641