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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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myelogenous Leukemia (AML); Acute Lymphocytic Leukemia (ALL); Graft vs. Host Disease (GvHD)

Intervention: Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] (Biological); Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] (Biological)

Phase: N/A

Status: Completed

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: Incidence of Grade II to IV acute GvHD in the first 100 days after transplant.

Secondary outcome:

Incidence of treatment related adverse events and serious adverse events at 100 days and 6 months post transplant

Patient survival at 100 days and 6 months after transplant

transplant related mortality at 100 days or 6 months after transplant

severity and outcomes of acute GvHD

any events of infection at 100 days and 6 months after transplant

incidence (or absence) of mucositis

how many days in the first month after transplant certain types of narcotics are used to reduce pain

whether the subject's blood counts after transplant reach a stable level and how quickly

incidence of re-hospitalization in the first 6 months after transplant

any recurrence of the subject's leukemic disease, and how long the subject was able to stay in remission

incidence and severity of chronic GvHD, and the extent, after 100 days and 6 months after transplant

Disease free survival


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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


- 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


- 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.

Locations and Contacts

University of Alabama-Birmingham Hospital, Birmingham, Alabama 35249, United States

UCLA Medical Center, Los Angeles, California 90095, United States

Shands at the University of Florida, Division of Hematology/Oncology, Gainesville, Florida 32610, United States

Emory University Hospital, Atlanta, Georgia 30322, United States

Dana Farber Cancer Institute Dana 1B11, Boston, Massachusetts 02115, United States

Massachusetts General Hospital Cox Bldg Room 640, Boston, Massachusetts 02114, United States

Beth Israel Deaconess Medical Center KS121, Brookline, Massachusetts 02215, United States

Washington University School of Medicine, St. Louis, Missouri 63110, United States

The Nebraska Medical Center, Omaha, Nebraska 68198, United States

Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey 07601, United States

Duke University Medical Center, Durham, North Carolina 27705, United States

Ottawa Hospital - General Campus, Ottawa, Ontario K1H 8L6, Canada

Princess Margaret Hospital, University Health Network, Toronto, Ontario M5G 2M9, Canada

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Additional Information

US FDA Approved Full Prescribing Information for Thymoglobulin®

Starting date: March 2004
Last updated: March 16, 2015

Page last updated: August 23, 2015

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