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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


Phase 2
N/A
26 Years
Open (Enrolling)
Both
Leukemia, Lymphoma, Bone Marrow Failure, Immunodeficiencies, Histiocytosis

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Trial Information

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


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 >60 ml/min/1.73 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 >40 ml/min/1.73 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety, toxicity and feasibility of CD34+ stem cell selection in children, adolescents and young adults receiving a partially matched family or matched unrelated adult donor allogeneic stem cell transplant

Outcome Time Frame:

10 years

Safety Issue:

Yes

Principal Investigator

Mitchell S Cairo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York Medical College

Authority:

United States: Institutional Review Board

Study ID:

L 10,321

NCT ID:

NCT01049854

Start Date:

September 2011

Completion Date:

December 2017

Related Keywords:

  • Leukemia
  • Lymphoma
  • Bone Marrow Failure
  • Immunodeficiencies
  • Histiocytosis
  • unrelated donor transplant
  • CD34 selection
  • Histiocytosis
  • Immunologic Deficiency Syndromes
  • Leukemia
  • Lymphoma
  • Pancytopenia

Name

Location

New York Medical CollegeValhalla, New York  10595