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Peripheral Blood Stem Cell Transplantation Using the CliniMACS Device

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ClinicalTrials.gov Identifier: NCT01071226
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : October 25, 2021
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Julie-An M. Talano, Medical College of Wisconsin

Study Description
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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 Phase
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) Other: HSCT Not Applicable

Study Design
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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
Actual Primary Completion Date : August 2016
Actual Study Completion Date : April 28, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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

Other: HSCT
Peripheral Blood Stem Cell Transplant
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

Other: HSCT
Peripheral Blood Stem Cell Transplant


Outcome Measures
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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 ]

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

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01071226


Locations
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United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital of Philadelphia
Investigators
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Principal Investigator: Julie A Talano, MD Medical College of Wisconsin
More Information
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Responsible Party: Julie-An M. Talano, Associate Professor of Pediatrics and Director of Clinical Pediatric BMT Research, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01071226    
Other Study ID Numbers: CHOP 07/216
First Posted: February 19, 2010    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021
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:
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Bone Marrow Failure Disorders
Pancytopenia
Bone Marrow Diseases
Hematologic Diseases