Peripheral Blood Stem Cell Transplantation Using the CliniMACS Device

This study is currently recruiting participants.
Verified April 2013 by Medical College of Wisconsin
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Julie-An M. Talano, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01071226
First received: February 17, 2010
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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 Intervention 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)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • To measure the incidence and quality of engraftment [ Time Frame: Weekly for first 100 days, 6 months and 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2008
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 22 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071226

Contacts
Contact: Julie A Talano, MD 414-955-4170 jtalano@mcw.edu
Contact: Kristine M Allmendinger-Goertz, BA 414-266-2137 kallmend@mcw.edu

Locations
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53058
Contact: Kristine Allmendinger-Goertz, BA    414-266-2137    kallmend@mcw.edu   
Principal Investigator: Julie A Talano, MD         
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Julie A Talano, MD Medical College of Wisconsin
  More Information

No publications provided

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     History of Changes
Other Study ID Numbers: CHOP 07/216
Study First Received: February 17, 2010
Last Updated: April 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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:
Leukemia
Lymphoma
Pancytopenia
Hemoglobinuria, Paroxysmal
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Anemia, Hemolytic
Anemia
Myelodysplastic Syndromes
Bone Marrow Diseases

ClinicalTrials.gov processed this record on April 15, 2014