Study Comparing ABX-CBL (Monoclonal Antibody) Versus Atga... | NCT00035880

Studies
Study Comparing ABX-CBL (Monoclonal Antibody) Versus Atgam in Patients With Steroid Resistant Acute Graft Versus Host Disease

NCT00035880

Sponsor

Abgenix

Status

Completed

Last Update Posted

Jun 24, 2005Estimated

Enrollment

Phase

Phase 2Phase 3

Conditions

Graft Vs Host Disease

Interventions

ABX-CBL

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2003

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 1999

Primary Completion Date

Not provided

Completion Date

Jun 2003

First Submitted Date

May 6, 2002

First Submission Date that Met QC Criteria

May 6, 2002

First Posted Date

May 7, 2002Estimated

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

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Name	Class
Sangstat Medical Corporation	INDUSTRY

Description Module

Brief Summary

Trial evaluating the improvement in survival at 180 days of two therapies (Atgam versus ABX-CBL, a monoclonal antibody) in patients with acute graft versus host disease that does not respond to steroid therapy.

Detailed Description

Not provided

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
ABX-CBL	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recipient of single allogeneic stem cell transplant from any donor type
Time post transplant less than 100 days
Received no treatment for GVHD other than steroids

Exclusion Criteria:

Recipient of second allogeneic stem cell transplant or subsequent lymphocyte product from the donor post transplant
IBMTR index less than A
Received any murine product in the past
Diagnosed with chronic GVHD
Received Atgam later than day 10 post transplant
Change to prophylactic regimen for acute GVHD within 72 hours of randomization

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided