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Peripheral Blood Stem Cell Transplantation Using the CliniMACS Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01071226
Recruitment Status : Active, not recruiting
First Posted : February 19, 2010
Last Update Posted : February 5, 2018
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Julie-An M. Talano, Medical College of Wisconsin

Brief Summary:
T cell depletion utilizing the CliniMACS device will allow more precise, specific and controlled graft engineering of peripheral blood stem cells from unrelated and partially matched related donors without an increase in relapse or graft rejection and grade III or IV acute graft versus host disease (GVHD).

Condition or disease Intervention/treatment
Malignant Diseases (ie, Leukemia, MDS, Lymphoma) Non-malignant Diseases (ie, Bone Marrow Failure Syndromes) Device: CliniMACS (CD+3, CD+19 depletion) Device: CliniMACS (CD 34+ positive selection)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With The CliniMACS Device for T and B Cell Depletion
Study Start Date : May 2008
Primary Completion Date : August 2016
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Stratum 1
Patients receiving an unrelated donor or partially matched related donor.
Device: CliniMACS (CD+3, CD+19 depletion)
Patient's in Stratum 1 will receive grafts that have undergone CD3+, CD19+ depletion
Experimental: Stratum 2
For the patient's whose donors are haploidentical or a 2 antigen mismatched where one of the mismatches includes DRB1
Device: CliniMACS (CD 34+ positive selection)
Patient's in Stratum 2 will receive peripheral blood progenitor cells that have undergone CD34+ selection

Primary Outcome Measures :
  1. To measure the incidence and quality of engraftment [ Time Frame: Weekly for first 100 days, 6 months and 1 year ]

Secondary Outcome Measures :
  1. Evaluate the incidence of acute Graft versus Health Disease and treatment related mortality. [ Time Frame: weekly for the first 100 days and then 6 and 12 months post transplant date ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01071226

United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53058
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital of Philadelphia
Principal Investigator: Julie A Talano, MD Medical College of Wisconsin

Responsible Party: Julie-An M. Talano, Associate Professor of Pediatrics and Director of Clinical Pediatric BMT Research, Medical College of Wisconsin Identifier: NCT01071226     History of Changes
Other Study ID Numbers: CHOP 07/216
First Posted: February 19, 2010    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

Keywords provided by Julie-An M. Talano, Medical College of Wisconsin:
Malignant and non-malignant diseases
Hematopoietic stem cell transplant
Peripheral blood progenitor cell transplant
CliniMACS device
T cell depletion

Additional relevant MeSH terms:
Anemia, Aplastic
Hemoglobinuria, Paroxysmal
Hematologic Diseases
Bone Marrow Diseases
Anemia, Hemolytic
Myelodysplastic Syndromes