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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-31

Study Completion Date

2003-06-30

Brief Summary

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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

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Conditions

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Graft Vs Host Disease

Keywords

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Acute graft versus host disease Stem Cell Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ABX-CBL

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Abgenix, Inc

Fremont, California, United States

Site Status

Countries

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United States

Other Identifiers

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ABX-CB-9906

Identifier Type: -

Identifier Source: org_study_id

NCT00012077