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NCT00220285 Clinical Trial

Study for Evaluation of Efficacy and Safety of SH L 749 to Indolent B-cell Non-Hodgkin's Lymphoma

Non-Hodgkin's Lymphoma Clinical Trial

Official title:
A Phase II Open-label Study of SH L 749 in Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphomas

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00220285
Other study ID # 91102
Secondary ID 305618
Status Completed
Phase Phase 2
First received September 21, 2005
Last updated December 29, 2014
Start date August 2004
Est. completion date October 2005

Study information
Verified date December 2014
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date October 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 74 Years
Eligibility 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.)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Zevalin (SH L 749 , BAY86-5128)
0,3mCi/kg
• Zevalin (SH L 749 , BAY86-5128)
0,4mCi/kg

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Best overall response rates (the percentage of patients who achieved PR or better response) After 9 weeks or 13 weeks
Primary The incidence of critical toxicity During treatment period
Secondary Safety evaluation During treatment period
Secondary Complete response (CR or CRu) rates After 9 weeks or 13 weeks
Secondary Progression-free survival (PFS) After end of study
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