NCT00035880

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 1999

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2002

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 2003

First QC Date

May 6, 2002

Last Update Submit

June 23, 2005

Conditions

Graft Vs Host Disease

Keywords

Acute graft versus host diseaseStem Cell Transplantation

Interventions

ABX-CBLDRUG

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abgenix, Inc

Fremont, California, 94555, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 6, 2002

First Posted

May 7, 2002

Study Start

October 1, 1999

Study Completion

June 1, 2003

Last Updated

June 24, 2005

Record last verified: 2003-07

Locations

US(1)