This trial is active, not recruiting.

Conditions malignant diseases (ie, leukemia, mds, lymphoma), non-malignant diseases (ie, bone marrow failure syndromes)
Treatments clinimacs (cd+3, cd+19 depletion), clinimacs (cd 34+ positive selection)
Phase phase 2
Sponsor Medical College of Wisconsin
Collaborator Children's Hospital of Philadelphia
Start date May 2008
End date December 2016
Trial size 60 participants
Trial identifier NCT01071226, CHOP 07/216


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Patients receiving an unrelated donor or partially matched related donor.
clinimacs (cd+3, cd+19 depletion)
Patient's in Stratum 1 will receive grafts that have undergone CD3+, CD19+ depletion
For the patient's whose donors are haploidentical or a 2 antigen mismatched where one of the mismatches includes DRB1
clinimacs (cd 34+ positive selection)
Patient's in Stratum 2 will receive peripheral blood progenitor cells that have undergone CD34+ selection

Primary Outcomes

To measure the incidence and quality of engraftment
time frame: Weekly for first 100 days, 6 months and 1 year

Secondary Outcomes

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

Male or female participants up to 22 years old.

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.

Additional Information

Official title CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With The CliniMACS Device for T and B Cell Depletion
Principal investigator Julie A Talano, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Medical College of Wisconsin.