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Phase 2
13 Years
65 Years
Open (Enrolling)

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Trial Information

Inclusion Criteria:

- We propose to study 144 patients undergoing allogeneic bone marrow transplantation or
peripheral blood stem cell transplant over a 4 year period.

- Patients of either sex and of any race or ethnic origin, older than age greater than
or equal to13, and admitted to the Myelosuppression Unit (MSU) of Vanderbilt
University Hospital or the VA Hospital to undergo bone marrow transplantation will be
recruited for this study.

Exclusion Criteria:

- Patients will be excluded if pregnant (unlikely) or if informed consent cannot be

- Because of the intrinsic toxicity of the treatment regimens, BMT is not usually
offered to patients with severe underlying derangements in organ function.
Nevertheless, other exclusions that will prevent entry of patients into the study
include advanced renal or hepatic failure (serum creatinine > 6mg/dl, serum bilirubin
>3.5 mg/dl), moribund patients, and patients whose primary physician is not committed
to full support of the patient (i.e. "Do Not Resuscitate").

- Other exclusions will include patients enrolled in another experimental
(interventional) protocol aimed at reducing transplant related complications during
BMT, patients testing positive for HIV, those who have had previous BMT, and patients
actively bleeding at the time of initiation of induction therapy. We will not
exclude patients undergoing newer regimens of cytotoxic chemotherapy.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Principal Investigator

Brian W. Christman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt University


United States: Food and Drug Administration

Study ID:




Start Date:

October 2001

Completion Date:

December 2007

Related Keywords:

  • Cancer
  • Peripheral Blood Stem Cell Transplant
  • Bone Marrow Transplant
  • Citrulline
  • Urea Cycle
  • Hepatic Injury
  • Allogeneic PBSCT
  • Matched-Unrelated PBSCT



Vanderbilt University Medical Center Nashville, Tennessee  37232-2516