Study for Evaluation of Efficacy and Safety of SH L 749 to Indolent B-cell Non-Hodgkin's Lymphoma
A Phase II Open-label Study of SH L 749 in Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphomas
2 other identifiers
interventional
45
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2004
Shorter than P25 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 21, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedDecember 30, 2014
December 1, 2014
September 21, 2005
December 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Best overall response rates (the percentage of patients who achieved PR or better response)
After 9 weeks or 13 weeks
The incidence of critical toxicity
During treatment period
Secondary Outcomes (3)
Safety evaluation
During treatment period
Complete response (CR or CRu) rates
After 9 weeks or 13 weeks
Progression-free survival (PFS)
After end of study
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Platelet counts of \>/= 100,000/mm3
- Absolute neutrophil counts of \>/= 1,200/mm3
- Bone marrow involvement \< 25%
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (9)
Unknown Facility
Nagoya, Aichi-ken, 464-8681, Japan
Unknown Facility
Kashiwa-shi, Chiba, 277-8577, Japan
Unknown Facility
Maebashi, Gunma, 371-8511, Japan
Unknown Facility
Kanazawa, Ishikawa-ken, 920-8641, Japan
Unknown Facility
Isehara-shi, Kanagawa, 259-1193, Japan
Unknown Facility
Kyoto, Kyoto, 602-0841, Japan
Unknown Facility
Sendai, Miyagi, 980-0872, Japan
Unknown Facility
Chuo-ku, Tokyo, 104-0045, Japan
Unknown Facility
Shinjuku-ku, Tokyo, 160-8582, Japan
Related Publications (1)
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.
PMID: 19018755DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 21, 2005
First Posted
September 22, 2005
Study Start
August 1, 2004
Study Completion
October 1, 2005
Last Updated
December 30, 2014
Record last verified: 2014-12