Yt90 Zevalin and Combination Chemotherapy (Z-CHOP)in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-cell Lymphoma
NCT ID: NCT00386321
Last Updated: 2010-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
10 participants
INTERVENTIONAL
2006-04-30
2010-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Chulalongkorn University
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Udomsak Bunworasate, M.D.
Role: PRINCIPAL_INVESTIGATOR
Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TH011103
Identifier Type: -
Identifier Source: org_study_id