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

Bayer

Status and phase: Completed; Phase 2

Conditions: Lymphoma, B-Cell; Lymphoma, Low-Grade; Non-Hodgkin's Lymphoma

Treatments: Drug: Zevalin (SH L 749 , BAY86-5128)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00220285

91102

305618

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Zevalin (SH L 749 , BAY86-5128)

Drug: Zevalin (SH L 749 , BAY86-5128)

Arm 2

Experimental group

Treatment:

Drug: Zevalin (SH L 749 , BAY86-5128)

Drug: Zevalin (SH L 749 , BAY86-5128)