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Yt90 Zevalin and Combination Chemotherapy (Z-CHOP)in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-cell Lymphoma

Primary Purpose

Diffuse Large B-cell Lymphoma

Status
Terminated
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin)
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring Zevalin, Zevalin plus CHOP, Diffuse large B-cell lymphoma, First line Diffuse large B-cell lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed CD20 positive diffuse large B-cell lymphoma with bulky stage II or stage III or stage IV
  • Bidimensionally measurable disease
  • Performance status Zubrod 0-2
  • Less than 20,000/mcL circulating lymphoid cells on WBC differential count
  • No clinical evidence of CNS involvement, no prior diagnosis of indolent lymphoma, no histologic transformation
  • Ejection fraction more than or equal to 45% by MUGA or no significant abnormality by echocardiogram
  • Fertile patients with effective contraception method
  • No other malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, stage I or II cancer in complete remission, or carcinoma in situ of cervix
  • No HIV positive, no prior solid organ transplantation
  • No prior antibody therapy, chemotherapy, radiotherapy for lymphoma

Exclusion Criteria:

  • Serum creatinine ot bilirubin more than 2.5 X ULN unless due to lymphoma
  • Active uncontrolled infection
  • Concurrent severe and/or uncontrolled medical disease which could compromise participation in the study
  • Patients with more than 25% infiltrated bone marrow
  • Patients with platelet counts less than 100,000/mcL or neutrophil counts less than 1,500/mcL

Sites / Locations

  • King Chulalongkorn Memorial Hospital

Outcomes

Primary Outcome Measures

2-year progression-free survival and overall survival of patients

Secondary Outcome Measures

Response rate (partial response, complete unconfirmed response, and complete response)in patients
2-year progression-free survival, overall survival and response rate in BCL-2 positive patients

Full Information

First Posted
October 10, 2006
Last Updated
November 17, 2010
Sponsor
Chulalongkorn University
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00386321
Brief Title
Yt90 Zevalin and Combination Chemotherapy (Z-CHOP)in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-cell Lymphoma
Official Title
Yt90Zevalin Plus CHOP, Z-CHOP
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Why Stopped
Participants are no longer being examined or treated.
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chulalongkorn University
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether the treatment of Yt90 Zevalin in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone)are effective as first line treatment in patients with bulky stage II or stage III or IV diffuse large B-cell lymphoma
Detailed Description
Radioimmunotherapy represents a significant advance over unlabeled immunotherapy for the treatment of patients with B-cell non-Hodgkin's lymphoma. The radiobiological effects associated with Yt90-labelled ibritumomab tiuxetan (Zevalin) include the induction of apoptosis and cell-cycle redistribution. The response rate tend to be higher in patients who have been treated with fewer prior therapies and Yt90-labelled ibritumomab tiuxetan may be suitable for use early in the course of therapy. Yt90-labelled ibritumomab tiuxetan has less non hematologic toxicity than chemotherapy, with only minimal alopecia, mucositis, nausea, or vomiting, and a lower incidence of infections. Yt90-labelled ibritumomab tiuxetan regimen is routinely and safely given in an outpatient setting and is completed in 7-9 days and is thus more convenient to be used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-cell Lymphoma
Keywords
Zevalin, Zevalin plus CHOP, Diffuse large B-cell lymphoma, First line Diffuse large B-cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin)
Primary Outcome Measure Information:
Title
2-year progression-free survival and overall survival of patients
Secondary Outcome Measure Information:
Title
Response rate (partial response, complete unconfirmed response, and complete response)in patients
Title
2-year progression-free survival, overall survival and response rate in BCL-2 positive patients

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed CD20 positive diffuse large B-cell lymphoma with bulky stage II or stage III or stage IV Bidimensionally measurable disease Performance status Zubrod 0-2 Less than 20,000/mcL circulating lymphoid cells on WBC differential count No clinical evidence of CNS involvement, no prior diagnosis of indolent lymphoma, no histologic transformation Ejection fraction more than or equal to 45% by MUGA or no significant abnormality by echocardiogram Fertile patients with effective contraception method No other malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, stage I or II cancer in complete remission, or carcinoma in situ of cervix No HIV positive, no prior solid organ transplantation No prior antibody therapy, chemotherapy, radiotherapy for lymphoma Exclusion Criteria: Serum creatinine ot bilirubin more than 2.5 X ULN unless due to lymphoma Active uncontrolled infection Concurrent severe and/or uncontrolled medical disease which could compromise participation in the study Patients with more than 25% infiltrated bone marrow Patients with platelet counts less than 100,000/mcL or neutrophil counts less than 1,500/mcL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Udomsak Bunworasate, M.D.
Organizational Affiliation
Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

Yt90 Zevalin and Combination Chemotherapy (Z-CHOP)in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-cell Lymphoma

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