Completed

Pilot Trial of Two Dose Levels of Thymoglobulin as Part of a Myeloablative-Conditioning for a Human Leukocyte Antigen (HLA) Identical Matched Related Donor (MRD) Stem Cell Transplant (SCT) With Cyclosporine (CSa) as Post-transplant Graft vs. Host Disease (GvHD) Prophylaxis

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What is being tested

Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]

Biological
Who is being recruted

Graft vs Host Disease+10

+ Hematologic Diseases

+ Immune System Diseases

From 18 to 55 Years
See all eligibility criteria
How is the trial designed

Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorGenzyme, a Sanofi Company
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2004

Actual date on which the first participant was enrolled.

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 GvHD, will not be used in this study. Subjects will be monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurs at month 1, 100 days and 6 months following the transplant. Approximately 60 study subjects from approximately 14 transplant centers in the United States and Canada will be enrolled.

Official TitlePilot Trial of Two Dose Levels of Thymoglobulin as Part of a Myeloablative-Conditioning for a Human Leukocyte Antigen (HLA) Identical Matched Related Donor (MRD) Stem Cell Transplant (SCT) With Cyclosporine (CSa) as Post-transplant Graft vs. Host Disease (GvHD) Prophylaxis 
NCT00088543
Principal SponsorGenzyme, a Sanofi Company
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Graft vs Host DiseaseHematologic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLeukemia, MyeloidLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Criteria

Inclusion Criteria: * Subject has an HLA-A, -B and -DRB1 identical related donor and must be fully matched at Class II. A high resolution molecular HLA typing (at least 4 digits) is mandatory for HLA Class II and optional for HLA Class I * Subject has confirmed diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) with acute myeloid leukemia (including secondary leukemia) in first complete remission (CR2) or acute lymphoid in CR1 or CR2. * Subject is \>= 18 and \<= 55 years of age. * Subject is receiving a myeloablative-conditioning regimen * Men and women of childbearing age potential agree to practice an acceptable and reliable form of contraception during the study. Women must not be lactating or pregnant, and must have a negative serum pregnancy test. * Subject has been fully informed and has signed an IRB-approved informed consent form. * Subject is willing and able to follow study procedures for the 6 months post-transplant. * The subject must be serologically negative for human immunodeficiency virus (HIV). * Subject agrees to be followed for possible long-term safety outcomes for up to 12 months post-transplant. * Subject has an ECOG performance score of 0-2. * Subject has a creatinine of \< 2.0mg/dL or creatinine clearance of \> 50mL/min. * Subject has an ejection fraction of \>= 40% * Subject has a serum bilirubin of \< 2mg/dL. Exclusion Criteria: * Subject is receiving fludarabine, a non-myeloablative regimen, or other purine analogues as part of the conditioning regimen. * Subject is receiving an ex vivo engineered or processed graft (CD34+ enrichment, T-cell depletion, etc.) * Subject has documented uncontrolled central nervous system (CNS) disease. * Subject is expected to receive or has received methotrexate for GvHD prophylaxis. * Subject has alanine aminotransferase (ALT)or aspartate aminotransferase (AST) level of \> 3x the upper limit of normal range within 3 weeks prior to transplant. * Subject has used any experimental agent within 30 days prior to the date of signing the informed consent. * Subject is receiving or has received a bone marrow transplant from a donor who has positive serology for HIV, hepatitis B virus(HBV), hepatitis C virus (HCV) or syphilis. * Subject has a known contraindication to administration of rabbit anti-thymocyte globulin. * Subject is currently abusing drugs or alcohol or, in the opinion of the Investigator, is at high risk for poor compliance. * Subject, who in the opinion of the Investigator, has significant medical or psychological problems that warrants exclusion. Examples of significant problems include, but are not limited to, morbid obesity or severe cardiac disease.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
total dose 4.5 mg/kg Thymoglobulin

Group II

Experimental
total dose 8.5 mg/kg Thymoglobulin

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 14 locations

Suspended

University of Alabama-Birmingham Hospital

Birmingham, United StatesSee the location
Suspended

UCLA Medical Center

Los Angeles, United States
Suspended

Shands at the University of Florida, Division of Hematology/Oncology

Gainesville, United States
Suspended

Emory University Hospital

Atlanta, United States
Completed14 Study Centers