A Phase II Open-Label Study of SH L 749 in Relapsed or Refractory Indolent B-Cell Non-Hodgkin's Lymphomas
20 Years
74 Years
Both
Non-Hodgkin's Lymphoma, Lymphoma, B-Cell, Lymphoma, Low-Grade
Trial Information
A Phase II Open-Label Study of SH L 749 in Relapsed or Refractory Indolent B-Cell Non-Hodgkin's Lymphomas
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.
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.)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Best overall response rates (the percentage of patients who achieved PR or better response)
Outcome Time Frame:
After 9 weeks or 13 weeks
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
91102
NCT ID:
NCT00220285
Start Date:
August 2004
Completion Date:
October 2005
Related Keywords:
- Non-Hodgkin's Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Low-Grade
- Antigen
- CD20
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
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