Allogeneic Hematopoietic Stem Cell Transplantation With Reduced Intensity Pre-transplant Conditioning for the Treatment of High-risk Hematological Malignancies (V3)



Status:Terminated
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:1 - 75
Updated:7/13/2018
Start Date:June 2010
End Date:December 2015

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Allogeneic Hematopoietic Stem Cell Transplantation With Reduced-Intensity Pre-Transplant Conditioning for the Treatment of High-Risk Hematological Malignancies

This is study is for patients that have been diagnosed with high-risk hematological
malignancies. The main purpose of this study is to confirm previously published results of
stem cell transplantation with reduced intensity pre-transplant conditioning. Patients will
be assigned to 1 of 3 regimens depending on the patient's diagnosis. Participants will be
followed by the transplant team for the remainder of the patient's life. Patient's will visit
MUSC daily, then visits will be reduced to frequent visits for up to 6 months. After 6
months, the visits will be reduced more depending on the patient's condition.


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
protocol.

- 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
period.

- 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.
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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from
Charleston, SC
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