CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transportation for T and B Cell Depletion (CliniMACs)
This is a pilot study with 2 strata to evaluate engraftment and graft vs. host disease (GVHD) in patients receiving unrelated or partially matched related donor peripheral stem cells using the CliniMACS system to positively deplete T cells to prevent severe GVHD. Feasibility will be tested, focusing on engraftment, treatment-related mortality (with a specific focus on interstitial pneumonitis) and severe GVHD.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transportation With the CliniMACs Device for T and B Cell Depletion|
- Rates of success of engraftment, day 100 treatment related mortality, acute GVHD, relapse and EBV LPD. Patients who die will be considered failure for the engraftment success evaluation, and relapsed for that endpoint. [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
1. CliniMACS CD3+/CD19+ depletion
Patients will receive grafts that have undergone CD3+ and CD19+ depletion. The CD3(-) fraction will be infused.
T and B Cell depletion
2. CliniMACS CD3+/CD19+ depletion
Stratum 2. CliniMACS CD3+/CD19+ depletion:
For patients in Stratum 2 we will perform CD3+ (T cell) and CD19+ (B cell) depletion. There will be no T cell add back in this stratum.
T and B Cell depletion
PRIMARY HYPOTHESIS: 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 vs. host disease (GVHD).
SECONDARY HYPOTHESIS: Use of the CliniMACS device will allow defined levels of T cell depletion to reflect the risk of severe GVHD in the donor/recipient pair.
Thus, patients with a relatively lower risk of severe GVHD will be assigned to Stratum 1 and receive a graft with lesser T cell depletion and a defined level of reinfused T cells. Patients with higher risk of severe GVHD or for whom there is no perceived clinical benefit of GVHD will be assigned to Stratum 2 and receive a more T cell-depleted graft.
Conditioning of the patient (except immunodeficiencies) includes :
- Thiotepa 5 mg/kg days for 2 days
- Cyclophosphamide 60 mg/kg days for 2 days
- Total body irradiation 200 cGy given twice a day for 3 days
Following conditioning patient's will receive stem cells that have been processed using the CliniMACS device. This processing is done in the stem cell laboratory at The Children's Hospital of Philadelphia. The Stem Cell Lab is accredited by the Foundation for the Accreditation of Cellular Therapy (FACT) and maintain complete standard operating procedures (SOP's) and procedure records.
Processing of cells using the CliniMACS will occur in accordance with the Investigator Brochure and Technical Manual following the laboratory SOPs and using aseptic technique. The CHOP Stem Cell Lab has extensive prior experience with automated cell processing technologies, including the CellPro Ceprate device and the Isolex 300i.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00579124
|Contact: Margaret T Tartaglione, R.N.||215 email@example.com|
|Contact: Patricia Hankins, RN||215 firstname.lastname@example.org|
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Margaret Tartaglione, RN 215-590-4029 email@example.com|
|Contact: Patricia Hankins, RN 215-590-5168 firstname.lastname@example.org|
|Principal Investigator: Nancy J Bunin, MD|
|Sub-Investigator: Stephan A Grupp, MD, PhD|
|Principal Investigator:||Nancy J Bunin, MD||Children's Hospital of Philadelphia|