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Pre-transplant Conditioning for the Treatment of High-risk Hematological Malignancies (V3)

1 Year
75 Years
Open (Enrolling)
Hematological Malignancies

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Trial Information

Pre-transplant Conditioning for the Treatment of High-risk Hematological Malignancies (V3)

Inclusion Criteria:

- A proven diagnosis of one of the conditions in Table 1.

- Prior therapy including blood or marrow transplant will not exclude patients for
reduced intensity transplant.

- Age < 75 years. Pediatric patients are eligible from the ages of 1 month to 18 years
if the transplant physician believes that co-morbid conditions significantly increase
the risk for a standard transplant regimen.

- HIV antibody negative.

- ECOG performance status 0-3, (or equivalent Karnofsky and Lansky performance scores
for patients <18yrs, see appendix 2)

- Availability of an HLA-identical related donor or suitable alternative donor, (≥7/8
allele match at A, B, C and DRB). Syngeneic transplants will not be allowed in this

- Due to the complexity of the study, all patients prior to enrollment will be assessed
by the PI or co-PI.

- Patient with marrow failure states or immune deficiency syndromes undergoing stem
cell transplants must be reviewed by one of the investigators to determine
eligibility for study.

- Adequate insurance coverage (or financial resources) to cover the costs associated
with the patient's transplant and, in the case of patients eligible for cohort C, to
cover the costs associated with I 131 Tositumomab treatment.

Exclusion Criteria:

- Active CNS involvement with malignant disease.

- Pregnancy.

- Fertile men or women unwilling to use contraceptive techniques during the study

- Creatinine clearance < 30 ml/min.

- Left ventricular ejection fraction <30% or clinical cardiac failure uncontrolled by
medical therapy.

- Pulmonary disease requiring supplemental oxygen therapy.

- Patients with estimated life span less than 1 year due to medical illnesses other
than the condition being treated on the study.

Donor Selection:

Inclusion Criteria

- Major HLA identical relative or genotypically matched unrelated donor (7-8/8 alleles)

- Donors must meet the selection criteria as defined by the Foundation for the
Accreditation of Cell Therapy (FACT) and will be screened per the American
Association of Blood Banks (AABB) guidelines.

Exclusion Criterion

- Positive anti-donor HLA antibody.

- Identical twin.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the treatment-related mortality rate of allogeneic stem cell transplants using reduced-intensity conditioning regimens within 1st 100-days.

Outcome Time Frame:

8 years

Safety Issue:


Principal Investigator

Robert Stuart, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of South Carolina


United States: Food and Drug Administration

Study ID:




Start Date:

June 2010

Completion Date:

June 2018

Related Keywords:

  • Hematological Malignancies
  • high-risk hematological malignancies
  • Neoplasms
  • Hematologic Neoplasms



Medical University of South Carolina Charleston, South Carolina  29425-0721