Clinical trial NCT00220285: Study for Evaluation of Efficacy and Safety of SH L 749 to Indolent B-cell Non-Hodgkin's Lymphoma
Official title: A Phase II Open-label Study of SH L 749 in Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Lymphoma, B-Cell
Lymphoma, Low-Grade
Keywords: Antigen
CD20
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.)

Primary outcomes:
measure: Best overall response rates (the percentage of patients who achieved PR or better response)
timeFrame: After 9 weeks or 13 weeks
measure: The incidence of critical toxicity
timeFrame: During treatment period
Secondary outcomes:
measure: Safety evaluation
timeFrame: During treatment period
measure: Complete response (CR or CRu) rates
timeFrame: After 9 weeks or 13 weeks
measure: Progression-free survival (PFS)
timeFrame: After end of study
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
state: Aichi
city: Kashiwa-shi
country: Japan
state: Chiba
city: Maebashi-shi
country: Japan
state: Gunma
city: Kanazawa-shi
country: Japan
state: Ishikawa
city: Isehara-shi
country: Japan
state: Kanagawa
city: Kyoto-shi
country: Japan
state: Kyoto
city: Sendai-shi
country: Japan
state: Miyagi
city: Chuo-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.