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CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With The CliniMACS Device for T and B Cell Depletion


Phase 2
N/A
22 Years
Open (Enrolling)
Both
Malignant Diseases (ie, Leukemia, MDS, Lymphoma), Non-malignant Diseases (ie, Bone Marrow Failure Syndromes)

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Trial Information

CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With The CliniMACS Device for T and B Cell Depletion


Inclusion Criteria:



- All races are eligible

- Malignant diseases: Leukemias and Lymphomas

- Non-malignant diseases: Severe Aplastic Anemia, immunodeficiencies

Exclusion Criteria:

- Lansky or Karnofsky > 70

- Echo > 27% shortening fraction

- renal function:serum creatinine < 1.5 x for normal age

- no active untreated infection

- DLCO > 50% of predicted value

- Hepatic: AST and ALT < 3x upper limit of normal; bilirubin < 2.0.

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 measure the incidence and quality of engraftment

Outcome Time Frame:

Weekly for first 100 days, 6 months and 1 year

Safety Issue:

Yes

Principal Investigator

Julie A Talano, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical College of Wisconsin

Authority:

United States: Food and Drug Administration

Study ID:

CHOP 07/216

NCT ID:

NCT01071226

Start Date:

May 2008

Completion Date:

May 2019

Related Keywords:

  • Malignant Diseases (ie, Leukemia, MDS, Lymphoma)
  • Non-malignant Diseases (ie, Bone Marrow Failure Syndromes)
  • Malignant and non-malignant diseases
  • Hematopoietic stem cell transplant
  • Peripheral blood progenitor cell transplant
  • CliniMACS device
  • T cell depletion
  • Leukemia
  • Lymphoma
  • Pancytopenia
  • Hemoglobinuria, Paroxysmal

Name

Location

Children's Hospital of WisconsinMilwaukee, Wisconsin  53201