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

Primary Purpose

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

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

Zevalin (SH L 749 , BAY86-5128)

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring Antigen, CD20

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept 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.)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

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

The incidence of critical toxicity

Secondary Outcome Measures

Safety evaluation

Complete response (CR or CRu) rates

Progression-free survival (PFS)

Full Information

NCT ID

NCT00220285

First Posted

September 21, 2005

Last Updated

December 29, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00220285

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

August 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Antigen, CD20

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Zevalin (SH L 749 , BAY86-5128)

Intervention Description

0,3mCi/kg

Intervention Type

Drug

Intervention Name(s)

Zevalin (SH L 749 , BAY86-5128)

Intervention Description

0,4mCi/kg

Primary Outcome Measure Information:

Title

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

Time Frame

After 9 weeks or 13 weeks

Title

The incidence of critical toxicity

Time Frame

During treatment period

Secondary Outcome Measure Information:

Title

Safety evaluation

Time Frame

During treatment period

Title

Complete response (CR or CRu) rates

Time Frame

After 9 weeks or 13 weeks

Title

Progression-free survival (PFS)

Time Frame

After end of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Nagoya-shi

State/Province

Aichi

ZIP/Postal Code

464-8681

Country

Japan

City

Kashiwa-shi

State/Province

Chiba

ZIP/Postal Code

277-8577

Country

Japan

City

Maebashi-shi

State/Province

Gunma

ZIP/Postal Code

371-8511

Country

Japan

City

Kanazawa-shi

State/Province

Ishikawa

ZIP/Postal Code

920-8641

Country

Japan

City

Isehara-shi

State/Province

Kanagawa

ZIP/Postal Code

259-1193

Country

Japan

City

Kyoto-shi

State/Province

Kyoto

ZIP/Postal Code

602-0841

Country

Japan

City

Sendai-shi

State/Province

Miyagi

ZIP/Postal Code

980-0872

Country

Japan

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

160-8582

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

19018755

Citation

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. doi: 10.1111/j.1349-7006.2008.00999.x. Epub 2008 Oct 24.

Results Reference

derived

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

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