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

Chulalongkorn University

Status and phase

Terminated

Phase 2

Conditions

Diffuse Large B-cell Lymphoma

Treatments

Drug: Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00386321

TH011103

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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