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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00220285
First received: September 21, 2005
Last updated: February 3, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Lymphoma, B-Cell
Lymphoma, Low-Grade
Drug: Zevalin (SH L 749 , BAY86-5128)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Open-Label Study of SH L 749 in Relapsed or Refractory Indolent B-Cell Non-Hodgkin's Lymphomas

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Best overall response rates (the percentage of patients who achieved PR or better response) [ Time Frame: After 9 weeks or 13 weeks ]
  • The incidence of critical toxicity [ Time Frame: During treatment period ]

Secondary Outcome Measures:
  • Safety evaluation [ Time Frame: During treatment period ]
  • Complete response (CR or CRu) rates [ Time Frame: After 9 weeks or 13 weeks ]
  • Progression-free survival (PFS) [ Time Frame: After end of study ]

Enrollment: 40
Study Start Date: August 2004
Study Completion Date: October 2005
Arms Assigned Interventions
Experimental: Arm 1 Drug: Zevalin (SH L 749 , BAY86-5128)
0,3mCi/kg
Experimental: Arm 2 Drug: Zevalin (SH L 749 , BAY86-5128)
0,4mCi/kg

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

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220285

Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Therapeutic Area Head, Bayer Yakuhin Ltd.
ClinicalTrials.gov Identifier: NCT00220285     History of Changes
Other Study ID Numbers: 91102, 305618
Study First Received: September 21, 2005
Last Updated: February 3, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
Antigen
CD20

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 24, 2014