Visilizumab in Treating Patients With Graft-Versus-Host Disease Following Donor Stem Cell Transplantation - Tabular View

Tracking Information

First Received Date ^ICMJE

August 5, 2002

Last Updated Date

February 6, 2009

Start Date ^ICMJE

March 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00042744 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Visilizumab in Treating Patients With Graft-Versus-Host Disease Following Donor Stem Cell Transplantation

Official Title ^ICMJE

Humanized Monoclonal Anti-CD3 Antibody Visilizumab As Second-Line Therapy For Glucocorticoid-Refractory, Acute GVHD

Brief Summary

RATIONALE: Visilizumab may suppress the immune system and may be an effective treatment for graft-versus-host disease caused by donor peripheral stem cell transplantation.

PURPOSE: Phase II trial to study the effectiveness of visilizumab in treating patients who have graft-versus-host disease following donor peripheral stem cell transplantation that has not responded to previous treatment.

Detailed Description

OBJECTIVES:

Determine the survival rate at 180 days after treatment with visilizumab (Nuvion) as second-line therapy in patients with glucocorticoid-refractory acute graft-versus-host disease after prior allogeneic hematopoietic stem cell transplantation.
Determine the safety of this drug in these patients.
Determine the clinical response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive visilizumab (Nuvion) IV for 1-2 doses.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care

Condition ^ICMJE

Graft Versus Host Disease

Intervention ^ICMJE

Biological: visilizumab

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Diagnosis of grade II-IV acute graft-versus-host disease (GVHD) meeting 1 of the following criteria:
- Progressive GVHD after receiving methylprednisolone (MePRDL) at a minimum dose of 2 mg/kg for 3 days
- Persistent grade III or IV GVHD after receiving MePRDL and cyclosporine (CYSP) or tacrolimus (FK506) for 7 days
- Persistent grade II GVHD after receiving MePRDL and CYSP or FK506 for 14 days
Must meet at least 1 of the following criteria:
- Evaluable skin rash
- Evaluable diarrhea
- Abdominal pain and cramping
- Evaluable hyperbilirubinemia in the absence of clinically defined veno-occlusive disease, viral hepatitis, or structural abnormalities, as indicated on either liver ultrasound or CT scans
Received prior allogeneic hematopoietic stem cell transplantation
Patients continue GVHD prophylaxis with CYSP or FK506 at the dose tolerated by renal function

PATIENT CHARACTERISTICS:

Age:

Any age

Performance status:

Karnofsky 30-100% OR
Lansky 30-100%

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

See Disease Characteristics

Renal:

See Disease Characteristics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

See Disease Characteristics

Chemotherapy:

Not specified

Endocrine therapy:

See Disease Characteristics

Radiotherapy:

Not specified

Surgery:

Not specified

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00042744

Responsible Party

Study ID Numbers ^ICMJE

CDR0000069416, PDL-1589

Study Sponsor ^ICMJE

PDL BioPharma, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

James Lowder, MD

Facet Biotech

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP