Trial Condition(s):

Non-Hodgkin's Lymphoma, Lymphoma, B-Cell, Lymphoma, Low-Grade

Study for evaluation of efficacy and safety of SH L 749 to indolent B-cell non-Hodgkin's lymphoma

Bayer Identifier:

91102

ClinicalTrials.gov Identifier:

NCT00220285

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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.)

Trial Summary

Enrollment Goal
45
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Zevalin (Ibritumomab tiuxetan, BAY86-5128)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Tohoku Daigaku Igakubu Fuzoku Byoin

Sendai-shi, Japan, 980-0872

Status
Completed
 
Locations

Tokai Daigaku Igakubu Fuzoku Byoin

Isehara-shi, Japan, 259-1193

Status
Completed
 
Locations

Gunma Daigaku Igakubu Fuzoku Byoin

Maebashi-shi, Japan, 371-8511

Status
Completed
 
Locations

Kokuritsu Gan Senta Higashi Byoin

Kashiwa-shi, Japan, 277-8577

Status
Completed
 
Locations

Kokuritsu Gan Senta Chuo Byoin

Chuo-ku, Japan, 104-0045

Status
Completed
 
Locations

Keio Gijuku Daigaku Byoin

Shinjuku-ku, Japan, 160-8582

Status
Completed
 
Locations

Kanazawa Daigaku Igakubu Fuzoku Byoin

Kanazawa-shi, Japan, 920-8641

Status
Completed
 
Locations

Aichi-ken Gan Senta Byoin

Nagoya-shi, Japan, 464-8681

Status
Completed
 
Locations

Kyoto Furitsu Ikadaigaku Fuzoku Byoin

Kyoto-shi, Japan, 602-0841

Status
Completed
 

Trial Design