Peripheral Blood Stem Cell Transplantation Using the CliniMACS Device

Malignant Diseases (ie, Leukemia, MDS, Lymphoma) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071226
• Other study ID #: CHOP 07/216
• Status: Completed
• Phase: N/A
• Start date: May 2008
• Est. completion date: April 28, 2020

Study information

• Verified date: October 2021
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 28, 2020
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Failure Disorders
• Malignant Diseases (ie, Leukemia, MDS, Lymphoma)
• Non-malignant Diseases (ie, Bone Marrow Failure Syndromes)
• Pancytopenia

Intervention

Device:
• CliniMACS (CD+3, CD+19 depletion)
Patient's in Stratum 1 will receive grafts that have undergone CD3+, CD19+ depletion
• 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

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the incidence and quality of engraftment		Weekly for first 100 days, 6 months and 1 year
Secondary	Evaluate the incidence of acute Graft versus Health Disease and treatment related mortality.		weekly for the first 100 days and then 6 and 12 months post transplant date