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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00386321
Recruitment Status : Terminated (Participants are no longer being examined or treated.)
First Posted : October 11, 2006
Last Update Posted : November 18, 2010
Information provided by:
Chulalongkorn University

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

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Drug: Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Yt90Zevalin Plus CHOP, Z-CHOP
Study Start Date : April 2006
Actual Primary Completion Date : July 2007
Estimated Study Completion Date : January 2010

Primary Outcome Measures :
  1. 2-year progression-free survival and overall survival of patients

Secondary Outcome Measures :
  1. Response rate (partial response, complete unconfirmed response, and complete response)in patients
  2. 2-year progression-free survival, overall survival and response rate in BCL-2 positive patients

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00386321

King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Principal Investigator: Udomsak Bunworasate, M.D. Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University Identifier: NCT00386321     History of Changes
Other Study ID Numbers: TH011103
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: November 18, 2010
Last Verified: November 2010

Keywords provided by Chulalongkorn University:
Zevalin plus CHOP
Diffuse large B-cell lymphoma
First line Diffuse large B-cell lymphoma

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs