Trial Condition(s):
Non-Hodgkin's Lymphoma
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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Tohoku Daigaku Igakubu Fuzoku Byoin Sendai-shi, Japan, 980-0872 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokai Daigaku Igakubu Fuzoku Byoin Isehara-shi, Japan, 259-1193 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gunma Daigaku Igakubu Fuzoku Byoin Maebashi-shi, Japan, 371-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kokuritsu Gan Senta Higashi Byoin Kashiwa-shi, Japan, 277-8577 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kokuritsu Gan Senta Chuo Byoin Chuo-ku, Japan, 104-0045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Keio Gijuku Daigaku Byoin Shinjuku-ku, Japan, 160-8582 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kanazawa Daigaku Igakubu Fuzoku Byoin Kanazawa-shi, Japan, 920-8641 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Aichi-ken Gan Senta Byoin Nagoya-shi, Japan, 464-8681 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyoto Furitsu Ikadaigaku Fuzoku Byoin Kyoto-shi, Japan, 602-0841 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A phase II open-label study of SH L 749 in relapsed or refractory indolent B-cell non-Hodgkin's lymphomas
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Best overall response rates (the percentage of patients who achieved PR or better response)Timeframe: After 9 weeks or 13 weeks
- The incidence of critical toxicityTimeframe: During treatment period
Secondary Outcome
- Safety evaluationTimeframe: During treatment period
- Complete response (CR or CRu) ratesTimeframe: After 9 weeks or 13 weeks
- Progression-free survival (PFS)Timeframe: After end of study
Additional Information
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