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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

This study has been terminated.
(Participants are no longer being examined or treated.)
Sponsor:
Collaborator:
Bayer
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT00386321
First received: October 10, 2006
Last updated: November 17, 2010
Last verified: November 2010
History of Changes
  Purpose

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 Intervention Phase
Diffuse Large B-cell Lymphoma
 Drug: Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Yt90Zevalin Plus CHOP, Z-CHOP

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Chulalongkorn University:

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

Enrollment: 10
Study Start Date: April 2006
Estimated Study Completion Date: January 2010
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386321

Locations
Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Bayer
Investigators
Principal Investigator: Udomsak Bunworasate, M.D. Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00386321     History of Changes
Other Study ID Numbers: TH011103
Study First Received: October 10, 2006
Last Updated: November 17, 2010
Health Authority: Thailand : Thai Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on June 17, 2013