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

September 21, 2005
February 3, 2009
August 2004
Not Provided
  • 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 ]
  • Best overall response rates (the percentage of patients who achieved PR or better response)
  • The incidence of critical toxicity
Complete list of historical versions of study NCT00220285 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Efficacy evaluation
  • Complete response (CR or CRu) rates
  • Progression-free survival (PFS)
Not Provided
Not Provided
 
Study for Evaluation of Efficacy and Safety of SH L 749 to Indolent B-Cell Non-Hodgkin's Lymphoma
A Phase II Open-Label Study of SH L 749 in Relapsed or Refractory Indolent B-Cell Non-Hodgkin's Lymphomas

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-Hodgkin's Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Low-Grade
  • Drug: Zevalin (SH L 749 , BAY86-5128)
    0,3mCi/kg
  • Drug: Zevalin (SH L 749 , BAY86-5128)
    0,4mCi/kg
  • Experimental: Arm 1
    Intervention: Drug: Zevalin (SH L 749 , BAY86-5128)
  • Experimental: Arm 2
    Intervention: Drug: Zevalin (SH L 749 , BAY86-5128)
Tobinai K, Watanabe T, Ogura M, Morishima Y, Hotta T, Ishizawa K, Itoh K, Okamoto S, Taniwaki M, Tsukamoto N, Okumura H, Terauchi T, Nawano S, Matsusako M, Matsuno Y, Nakamura S, Mori S, Ohashi Y, Hayashi M, Endo K. Japanese phase II study of 90Y-ibritumomab tiuxetan in patients with relapsed or refractory indolent B-cell lymphoma. Cancer Sci. 2009 Jan;100(1):158-64. Epub 2008 Oct 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2005
Not Provided

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.)
Both
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00220285
91102, 305618
Yes
Therapeutic Area Head, Bayer Yakuhin Ltd.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP