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

Phase 2

Completed

• Conditions: Lymphoma, B-Cell; Non-Hodgkin's Lymphoma; Lymphoma, Low-Grade
• Interventions: Drug: Zevalin (SH L 749 , BAY86-5128)

• Registration Number: NCT00220285
• Lead Sponsor: Bayer

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.

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-21
• Study First Submitted QC: 2005-09-21
• Study First Posted: 2005-09-22
• Study Completion: 2005-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-29
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Zevalin (SH L 749 , BAY86-5128)	-
Arm 1	Zevalin (SH L 749 , BAY86-5128)	-

Primary Outcome Measures

Name	Time	Method
The incidence of critical toxicity	During treatment period
Best overall response rates (the percentage of patients who achieved PR or better response)	After 9 weeks or 13 weeks

Secondary Outcome Measures

Name	Time	Method
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