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Completed

NCT Number: NCT00220285

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

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.

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Key information

Conditions

Non-Hodgkin's Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Low-Grade Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nagoya, Aichi-ken, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Zevalin (SH L 749 , BAY86-5128)

Drug

0,3mCi/kg

Primary outcomes

  1. Best overall response rates (the percentage of patients who achieved PR or better response)

    Time frame: After 9 weeks or 13 weeks

  2. The incidence of critical toxicity

    Time frame: During treatment period

Secondary outcomes

  1. Safety evaluation

    Time frame: During treatment period

  2. Complete response (CR or CRu) rates

    Time frame: After 9 weeks or 13 weeks

  3. Progression-free survival (PFS)

    Time frame: After end of study

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Sep 22, 2005
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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