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

NCT00386321 | Terminated Phase 2

• 1 other identifier: TH011103
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Diffuse Large B-cell Lymphoma

Keywords

Zevalin; Zevalin plus CHOP; Diffuse large B-cell lymphoma; First line Diffuse large B-cell lymphoma

Outcome Measures

Primary Outcomes (1)

• 2-year progression-free survival and overall survival of patients

Secondary Outcomes (2)

• 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

Interventions

Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin) DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead
• Bayer: collaborator

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Udomsak Bunworasate, M.D.

  Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 11, 2006
• Study Start: April 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: January 1, 2010
• Last Updated: November 18, 2010

Record last verified: 2010-11

Locations

TH (1)