Yt90 Zevalin and Combination Chemotherapy (Z-CHOP)in Trea... | NCT00386321

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Participants are no longer being examined or treated.

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Jul 2007Actual

Completion Date

Jan 2010Estimated

First Submitted Date

Oct 10, 2006

First Submission Date that Met QC Criteria

Oct 10, 2006

First Posted Date

Oct 11, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2010

Last Update Posted Date

Nov 18, 2010Estimated

Name	Class
Bayer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Name	Type	Description	Arm Group Labels	Other Names
Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
2-year progression-free survival and overall survival of patients

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Udomsak Bunworasate, M.D.	Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Chulalongkorn Memorial Hospital		Bangkok		10330	Thailand

ID	Term
D016393	Lymphoma, B-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases