Peripheral Blood Stem Cell Transplantation Using the CliniMACS Device

Medical College of Wisconsin

Status: Completed

Conditions: Malignant Diseases (ie, Leukemia, MDS, Lymphoma); Non-malignant Diseases (ie, Bone Marrow Failure Syndromes)

Treatments: Other: HSCT; Device: CliniMACS (CD+3, CD+19 depletion); Device: CliniMACS (CD 34+ positive selection)

Study type: Interventional

Funder types: Other

Identifiers

NCT01071226

CHOP 07/216

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: Under 22 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Stratum 1

Experimental group

Description:

Patients receiving an unrelated donor or partially matched related donor.

Treatment:

Other: HSCT

Device: CliniMACS (CD+3, CD+19 depletion)

Stratum 2

Experimental group

Description:

For the patient's whose donors are haploidentical or a 2 antigen mismatched where one of the mismatches includes DRB1

Treatment:

Other: HSCT

Device: CliniMACS (CD 34+ positive selection)