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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


N/A
18 Years
55 Years
Not Enrolling
Both
Acute Myelogenous Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Graft vs. Host Disease (GvHD)

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

100 days

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

United States: Food and Drug Administration

Study ID:

SMC-101-1026

NCT ID:

NCT00088543

Start Date:

March 2004

Completion Date:

April 2006

Related Keywords:

  • Acute Myelogenous Leukemia (AML)
  • Acute Lymphocytic Leukemia (ALL)
  • Graft vs. Host Disease (GvHD)
  • Acute myelogenous leukemia (AML)
  • Acute lymphocytic leukemia (ALL)
  • Anti-T cell antibodies
  • Allogenic stem cell transplant
  • Graft vs. Host Disease (GvHD)
  • Graft vs Host Disease
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Duke University Medical CenterDurham, North Carolina  27710
UCLA Medical CenterLos Angeles, California  90095-7059
University of Alabama-Birmingham HospitalBirmingham, Alabama  35249
Shands at the University of Florida, Division of Hematology/OncologyGainesville, Florida  32610
Emory University HospitalAtlanta, Georgia  30322
Dana Farber Cancer Institute Dana 1B11Boston, Massachusetts  02115
Massachusetts General Hospital Cox Bldg Room 640Boston, Massachusetts  02114
Beth Israel Deaconess Medical Center KS121Brookline, Massachusetts  02215
The Nebraska Medical CenterOmaha, Nebraska  68198