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NCT00088543 · ClinicalTrials.gov registry record · NA

Thymoglobulin to Prevent Acute Graft vs. Host Disease (GvHD) in Patients With Acute Lymphocytic Leukemia (ALL) or Acute Myelogenous Leukemia (AML) Receiving a Stem Cell Transplant

A NA study of Acute Myelogenous Leukemia (AML) and Acute Lymphocytic Leukemia (ALL), sponsored by Genzyme, a Sanofi Company.

Completed
Registry status
NA
Development phase
60
Enrollment target
14
Study locations

NCT00088543 is a NA study of Acute Myelogenous Leukemia (AML) and Acute Lymphocytic Leukemia (ALL) that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 60 participants, above the 45-participant average among 6 other Acute Myelogenous Leukemia (AML) trials with a reported enrollment target (33% higher). The trial reports 14 study locations across 11 states.

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The verdict

NCT00088543, a NA study of Acute Myelogenous Leukemia (AML) and Acute Lymphocytic Leukemia (ALL), has completed, sponsored by Genzyme, a Sanofi Company.

COMPLETED
Registry status
NA
Development phase
60 participants
Enrollment target
14
Study locations

Study Summary

This study involves the use of a drug called Thymoglobulin, which is approved in the USA to treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant rejection. Thymoglobulin is not approved for the treatment or prophylaxis of graft versus host disease in bone marrow transplantation. This study is to evaluate two (2) doses of Thymoglobulin and its safety and effectiveness when used with a "myeloablative" conditioning regimen prior to receiving a stem cell transplant (also called bone marrow transplantation) from a matched, related donor. A myeloablative regimen is typically composed of chemotherapy and radiation and destroys the subject's existing bone marrow. Subjects meeting all inclusion and exclusion criteria and who have a relative with matching (genetically similar) stem cells who are also willing to donate them (i.e. matched-related-donor) are eligible to participate in this study. Following myeloablative therapy, the donor's cells are then transplanted (i.e. infused) into the subject's blood stream. One of the most common complications of this type of transplant is graft-versus-host disease (GvHD). This is a condition where the transplanted donor cells attack the transplant recipient's body. Treatments, such as cyclosporine, are used to minimize the risk of GvHD following stem cell transplantation. To enter this study, subjects must be having a matched-related donor stem cell transplant. If a subject qualifies for entry into this study, he/she will be assigned to receive Thymoglobulin at a dose of 4.5 mg/kg or 8.5 mg/kg. The treatment assignment is random and is not chosen by the subject or their physician. Subjects are admitted to the hospital for the transplant procedure and are treated with Thymoglobulin over 3-5 days just prior to receiving the donor stem cells. The subject will also receive standard GvHD prophylaxis with cyclosporine. Methotrexate, which is commonly used by transplant centers to minimize the risk of

Conditions Studied

Acute Myelogenous Leukemia (AML) Acute Lymphocytic Leukemia (ALL) Graft vs. Host Disease (GvHD)

Interventions

  • BIOLOGICAL Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]

Study Locations (14)

Massachusetts

  • Massachusetts General Hospital Cox Bldg Room 640 - Boston
  • Dana Farber Cancer Institute Dana 1B11 - Boston
  • Beth Israel Deaconess Medical Center KS121 - Brookline

Ontario

  • Ottawa Hospital - General Campus - Ottawa
  • Princess Margaret Hospital, University Health Network - Toronto

Alabama

  • University of Alabama-Birmingham Hospital - Birmingham

California

  • UCLA Medical Center - Los Angeles

Florida

  • Shands at the University of Florida, Division of Hematology/Oncology - Gainesville

Georgia

  • Emory University Hospital - Atlanta

Missouri

  • Washington University School of Medicine - St Louis

Nebraska

  • The Nebraska Medical Center - Omaha

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2004-03
Est. Completion 2006-04
Phase NA

Sponsor

Genzyme, a Sanofi Company

196 total trials

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What the Registry Record Tells You About NCT00088543

The ClinicalTrials.gov registry entry for NCT00088543 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 45-participant average among 6 other Acute Myelogenous Leukemia (AML) trials with a reported enrollment target (33% higher). The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Acute Myelogenous Leukemia (AML) appearing as the primary indexed condition, and to 1 intervention - of which Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] is the first listed.

NCT00088543 reports 14 study locations spanning 11 distinct geographic areas - top geographies include Massachusetts, Ontario, Alabama.

Frequently Asked Questions

What is clinical trial NCT00088543 about?

NCT00088543 is a clinical study titled "Thymoglobulin to Prevent Acute Graft vs. Host Disease (GvHD) in Patients With Acute Lymphocytic Leukemia (ALL) or Acute Myelogenous Leukemia (AML) Receiving a Stem Cell Transplant". This study involves the use of a drug called Thymoglobulin, which is approved in the USA to treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant rejection. Thymoglobulin is not approved for the treatment or prophylaxis of graft versus host disease in bone marrow ...

What is the current status of trial NCT00088543?

This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2004-03. Estimated completion is 2006-04.

What conditions does trial NCT00088543 study?

This clinical trial studies the following conditions: Acute Myelogenous Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Graft vs. Host Disease (GvHD).

What interventions are being tested in trial NCT00088543?

The interventions under investigation include: Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] (BIOLOGICAL).

Who is sponsoring clinical trial NCT00088543?

This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00088543 being conducted?

This trial has 14 study locations across Alabama, California, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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