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

Sponsor

Chulalongkorn University (Other)

Overall Status

Terminated

CT.gov ID

NCT00386321

Collaborator

Bayer (Industry)

Enrollment

Location

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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

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 Design

Study Type:

Interventional

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 :

Apr 1, 2006

Actual Primary Completion Date :

Jul 1, 2007

Anticipated Study Completion Date :

Jan 1, 2010

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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