- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00088543
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
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
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Hospital - General Campus
-
Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital, University Health Network
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35249
- University of Alabama-Birmingham Hospital
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA Medical Center
-
-
Florida
-
Gainesville, Florida, United States, 32610
- Shands at the University of Florida, Division of Hematology/Oncology
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University Hospital
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital Cox Bldg Room 640
-
Boston, Massachusetts, United States, 02115
- Dana Farber Cancer Institute Dana 1B11
-
Brookline, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center KS121
-
-
Missouri
-
St. Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Nebraska
-
Omaha, Nebraska, United States, 68198
- The Nebraska Medical Center
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Cancer Center at Hackensack University Medical Center
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke University Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 Low dose
total dose 4.5 mg/kg Thymoglobulin
|
total dose 4.5 mg/kg
total dose 8.5 mg/kg
|
Experimental: 2 High dose
total dose 8.5 mg/kg Thymoglobulin
|
total dose 4.5 mg/kg
total dose 8.5 mg/kg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of Grade II to IV acute GvHD in the first 100 days after transplant.
Time Frame: 100 days
|
100 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of treatment related adverse events and serious adverse events at 100 days and 6 months post transplant
Time Frame: 100 days and 6 months
|
100 days and 6 months
|
Patient survival at 100 days and 6 months after transplant
Time Frame: 100 days and 6 months
|
100 days and 6 months
|
transplant related mortality at 100 days or 6 months after transplant
Time Frame: 100 days and 6 months
|
100 days and 6 months
|
severity and outcomes of acute GvHD
Time Frame: 100 days & 6 mos
|
100 days & 6 mos
|
any events of infection at 100 days and 6 months after transplant
Time Frame: 100 days and 6 months
|
100 days and 6 months
|
incidence (or absence) of mucositis
Time Frame: continuous
|
continuous
|
how many days in the first month after transplant certain types of narcotics are used to reduce pain
Time Frame: 30days
|
30days
|
whether the subject's blood counts after transplant reach a stable level and how quickly
Time Frame: Continuous
|
Continuous
|
incidence of re-hospitalization in the first 6 months after transplant
Time Frame: 6 months
|
6 months
|
any recurrence of the subject's leukemic disease, and how long the subject was able to stay in remission
Time Frame: Continuous
|
Continuous
|
incidence and severity of chronic GvHD, and the extent, after 100 days and 6 months after transplant
Time Frame: 100 days and 6 months
|
100 days and 6 months
|
Disease free survival
Time Frame: 100 days and 6 months
|
100 days and 6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
- Graft vs Host Disease
- Physiological Effects of Drugs
- Immunosuppressive Agents
- Immunologic Factors
- Thymoglobulin
- Antilymphocyte Serum
Other Study ID Numbers
- SMC-101-1026
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Myelogenous Leukemia (AML)
-
Eisai Inc.TerminatedPediatric Acute Myelogenous Leukemia (AML)United States, Canada, Australia
-
Maxinovel Pty., Ltd.RecruitingAcute Myelogenous Leukemia (AML)Australia
-
AbbVieGenentech, Inc.CompletedAcute Myeloid Leukemia | AML | Acute Myelogenous Leukemia
-
Merck Sharp & Dohme LLCTerminatedAcute Myelogenous Leukemia (AML)
-
Maxinovel Pty., Ltd.Recruiting
-
AbbVieGenentech, Inc.CompletedAML | Acute Myelogenous LeukemiaUnited States, Australia, Germany, Italy
-
Emory UniversityTeva Pharmaceuticals USATerminated
-
Sidney Kimmel Cancer Center at Thomas Jefferson...University of PennsylvaniaCompleted
-
Eisai Inc.Withdrawn
-
Ascenta TherapeuticsThe Leukemia and Lymphoma SocietyTerminated
Clinical Trials on Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]
-
University of CincinnatiGenzyme, a Sanofi CompanyCompletedRenal Transplant Rejection | Transplants and ImplantsUnited States
-
Wright State UniversitySanofi; University of Nebraska; University of Arizona; The Methodist Hospital Research... and other collaboratorsCompletedSafety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation (STAT)End-Stage Renal Disease | Kidney FailureUnited States
-
The Hospital for Sick ChildrenTerminatedMetabolic Disease | Genetic Disorder | MalignancyCanada
-
Genzyme, a Sanofi CompanyTerminatedMyelodysplastic Syndrome (MDS)Germany, United Kingdom, France, Netherlands
-
Genzyme, a Sanofi CompanyCompletedGraft Rejection | Renal TransplantationUnited States
-
Anhui Provincial HospitalRecruitingSevere Aplastic AnemiaChina
-
Genzyme, a Sanofi CompanyCompletedCadaveric Donor Renal Transplantation | Acute Renal Allograft Rejection | Induction TherapyUnited States, France, Spain, United Kingdom, Germany
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); Genzyme, a Sanofi Company; The...UnknownHematologic MalignanciesCanada
-
Shanghai General Hospital, Shanghai Jiao Tong University...The First Affiliated Hospital with Nanjing Medical University; The First Affiliated... and other collaboratorsUnknownAcute Lymphoblastic Leukemia | Lymphoblastic LymphomaChina
-
Medical University InnsbruckCompletedOrgan Preservation Solutions