NCT00088543

Brief 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 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2004

Typical duration for not_applicable

Geographic Reach
2 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2004

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

2.1 years

First QC Date

July 29, 2004

Last Update Submit

March 16, 2015

Conditions

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

Keywords

Acute myelogenous leukemia (AML)Acute lymphocytic leukemia (ALL)Anti-T cell antibodiesAllogenic stem cell transplantGraft vs. Host Disease (GvHD)

Outcome Measures

Primary Outcomes (1)

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

    100 days

Secondary Outcomes (12)

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

    100 days and 6 months

  • Patient survival at 100 days and 6 months after transplant

    100 days and 6 months

  • transplant related mortality at 100 days or 6 months after transplant

    100 days and 6 months

  • severity and outcomes of acute GvHD

    100 days & 6 mos

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

    100 days and 6 months

  • +7 more secondary outcomes

Study Arms (2)

1 Low dose

EXPERIMENTAL

total dose 4.5 mg/kg Thymoglobulin

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

2 High dose

EXPERIMENTAL

total dose 8.5 mg/kg Thymoglobulin

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

Interventions

Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]BIOLOGICAL

total dose 4.5 mg/kg

1 Low dose

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

University of Alabama-Birmingham Hospital

Birmingham, Alabama, 35249, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

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

Gainesville, Florida, 32610, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital Cox Bldg Room 640

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute Dana 1B11

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center KS121

Brookline, Massachusetts, 02215, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

The Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Hospital, University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaGraft vs Host Disease

Interventions

thymoglobulinAntilymphocyte Serum

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex Mixtures

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2004

First Posted

July 30, 2004

Study Start

March 1, 2004

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

US(12)CA(2)