CD34+Selection for Partially Matched Family or Matched Unrelated Adult Donor Transplant



Status:Completed
Conditions:Other Indications, Blood Cancer, Infectious Disease, HIV / AIDS, Lymphoma, Anemia, Hematology, Leukemia
Therapuetic Areas:Hematology, Immunology / Infectious Diseases, Oncology, Other
Healthy:No
Age Range:Any - 70
Updated:8/23/2018
Start Date:September 2011
End Date:August 2018

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CD34+Stem Cell Selection for Patients Receiving Partially Matched Family or Matched Unrelated Adult Donor Allogeneic Stem Cell Transplantations for Malignant and Non-Malignant Disease

CD34+ stem cell selection in children, adolescents and young adults receiving partially
matched family donor or matched unrelated adult donor allogeneic bone marrow or peripheral
blood stem cell transplant will be safe and well tolerated and be associated with a low
incidence of serious (Grade III/IV) acute and chronic graft versus host disease (GVHD).

The selection of CD34+ cells is associated with the simultaneous depletion of T cells that
are responsible for severe acute and chronic graft versus host disease (GVHD). Successful
engraftment is reported in adult patients with malignant and non-malignant disease who
received CD34+ selected stem cells from HLA-matched or mismatched mobilized peripheral blood
(PBSC) or bone marrow.

Study Design:

Selected patients defined in the eligibility criteria will enrolled on this study. Patients
will receive one of either full intensity or reduced intensity regimen based on the patient's
disease status, organ function and performance and determined by the PI and will have
peripheral blood undergo CD34 selection.

Inclusion Criteria:

- Adequate renal function defined as:Serum creatinine <1.5 x normal, or Creatinine
clearance or radioisotope GFR >60 ml/min/m2 or an equivalent GFR as determined by the
institutional normal range.

- Adequate liver function defined as:Total bilirubin <1.5 x normal, or SGOT (AST) or
SGPT (ALT) <3.0 x normal

- Adequate cardiac function defined as:Shortening fraction >27% by echocardiogram, or
Ejection fraction of >47% by radionucleotide angiogram or echocardiogram.

- Adequate pulmonary function defined as:Uncorrected DLCO >50% by pulmonary function
test. For children who are uncooperative, no evidence of dyspnea at rest, no exercise
intolerance, and a pulse oximetry >94% on room air.

Eligibility for Reduced Intensity Regimen:

- Adequate renal function defined as:Serum creatinine 2.0 x normal, or creatinine
clearance or radioisotope GFR > 40 ml/min/m2 or an equivalent GFR as determined by the
institutional normal range.

- Adequate liver function defined as:Total bilirubin < 2.5 x normal; or SGOT (AST) or
SGPT (ALT) < 5.0 x normal.

- Adequate cardiac function defined as:Shortening fraction of >25% by echocardiogram, or
Ejection fraction of >40% by radionuclide angiogram or echocardiogram.

- Adequate pulmonary function defined as:DLCO >35% by pulmonary function test. For
children who are uncooperative, no evidence of dyspnea at rest, no exercise
intolerance, and a pulse oximetry >94% in room air.

Exclusion Criteria:

- Pregnancy/Breast Feeding: Females who are pregnant or breast-feeding are not eligible.

- Infection: Patients with documented uncontrolled infection at the time of study entry
are not eligible.
We found this trial at
1
site
40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
Phone: 617-285-7844
New York Medical College The College was founded in 1860 by a group of New...
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mi
from
Valhalla, NY
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