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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
NCT00088543 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2004-03 |
| Est. Completion | 2006-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00088543
The ClinicalTrials.gov registry entry for NCT00088543 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00088543 reports 14 study locations spanning 11 distinct geographic areas — top geographies include Massachusetts, Ontario, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00088543?
The interventions under investigation include: Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00088543?
This trial is sponsored by Genzyme, a Sanofi Company, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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