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

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

Yt90Zevalin Plus CHOP, Z-CHOP

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00386321
• Other study ID #: TH011103
• Status: Terminated
• Phase: Phase 2
• First received: October 10, 2006
• Last updated: November 17, 2010
• Start date: April 2006
• Est. completion date: January 2010

Study information

• Verified date: November 2010
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand : Thai Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 2010
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin)

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Chulalongkorn University	Bayer

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year progression-free survival and overall survival of patients
Secondary	Response rate (partial response, complete unconfirmed response, and complete response)in patients
Secondary	2-year progression-free survival, overall survival and response rate in BCL-2 positive patients