check_circleStudy Completed

Non-Hodgkin's Lymphoma, Lymphoma, B-Cell, Lymphoma, Low-Grade

Bayer Identifier:

91102

ClinicalTrials.gov Identifier:

NCT00220285

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study for evaluation of efficacy and safety of SH L 749 to indolent B-cell non-Hodgkin's lymphoma

Trial 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.

Key Participants Requirements

Sex

Both

Age

20 - 74 Years
  • - Platelet counts of >/= 100,000/mm3
    - Absolute neutrophil counts of >/= 1,200/mm3
    - Bone marrow involvement < 25%
  • - 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 summary

Enrollment Goal
45
Trial Dates
August 2004 - October 2005
Phase
Phase 2
Could I Receive a placebo
No
Products
Zevalin (Ibritumomab tiuxetan, BAY86-5128)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Tohoku Daigaku Igakubu Fuzoku ByoinSendai-shi, 980-0872, Japan
Completed
Tokai Daigaku Igakubu Fuzoku ByoinIsehara-shi, 259-1193, Japan
Completed
Gunma Daigaku Igakubu Fuzoku ByoinMaebashi-shi, 371-8511, Japan
Completed
Kokuritsu Gan Senta Higashi ByoinKashiwa-shi, 277-8577, Japan
Completed
Kokuritsu Gan Senta Chuo ByoinChuo-ku, 104-0045, Japan
Completed
Keio Gijuku Daigaku ByoinShinjuku-ku, 160-8582, Japan
Completed
Kanazawa Daigaku Igakubu Fuzoku ByoinKanazawa-shi, 920-8641, Japan
Completed
Aichi-ken Gan Senta ByoinNagoya-shi, 464-8681, Japan
Completed
Kyoto Furitsu Ikadaigaku Fuzoku ByoinKyoto-shi, 602-0841, Japan

Primary Outcome

  • Best overall response rates (the percentage of patients who achieved PR or better response)
    date_rangeTime Frame:
    After 9 weeks or 13 weeks
    enhanced_encryption
    Safety Issue:
    None
  • The incidence of critical toxicity
    date_rangeTime Frame:
    During treatment period
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Safety evaluation
    date_rangeTime Frame:
    During treatment period
    enhanced_encryption
    Safety Issue:
    None
  • Complete response (CR or CRu) rates
    date_rangeTime Frame:
    After 9 weeks or 13 weeks
    enhanced_encryption
    Safety Issue:
    None
  • Progression-free survival (PFS)
    date_rangeTime Frame:
    After end of study
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    Safety Issue:
    None

Trial design

A phase II open-label study of SH L 749 in relapsed or refractory indolent B-cell non-Hodgkin's lymphomas
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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