|Patient age||Median (range)||48 (21-60)|
Based on published results of unmodified transplants from HLA-matched siblings administered to patients with AML, the primary endpoint of the study stated that a significant improvement in clinical outcome would be expected if DFS probability at 6 months in patients receiving a
T cell–depleted allograft was > 75%.
|Endpoints||BMT CTN 0303 (n=37)|
|% Neutrophil Engraftment at Day 30 (>500/μL)*||100%|
|% Platelet Engraftment at Day 30 (>20,000/μL)*||92% (82.4, 100)|
|Acute GVHD at Day 100 Grades 2-4*||27% (13.9, 42.0)|
|Acute GVHD at Day 100 Grades 3-4*||5% (1, 16.1)|
|Chronic GVHD at 2 years*||19% (8.2, 33.0)|
|Relapse Rate at 2 years*||16% (6.5, 29.9)|
|Non-relapse Mortality at 2 years*||20% (8.5, 34.5)|
|Overall survival at 2 years||67% (48.8, 79.7)|
|Disease Free Survival at 2 years||64% (46.0|
|GVHD Free Survival at 2 years||46% (29.6, 60.9)|
|* Cumulative Incidence|
The primary endpoint of the trial was met. DFS probability at 6 months post transplantation was 81.8% for all transplanted patients.
None of the sites reported any unexpected grades III-IV adverse events. Adverse events in this study were due to regimen-related events and toxicities common to allogeneic hematopoietic stem cell transplantation and could not be attributed to the CliniMACS CD34 Reagent System. In general, it can be stated that no observed adverse event can be attributed to the CliniMACS CD34 Reagent System or any of its components.
All allografts transplanted in this study were enriched for CD34+ cells using the CliniMACS CD34 Reagent System.
Eighty-four selection procedures were performed on HPC, Apheresis collected from a total of 44 donors. The minimum number of CD34+ cells required for transplantation, greater than 2 x 106 per kg recipient body weight, was achieved for 100% (44) of donors. The target number of CD34+ cells, greater than 5x106 per kg recipient body weight, was achieved for 84% (37) of the 44 donors. Device performance is shown in the table below.
|Attributes Measured||Mean||Std Dev||Median||Min||Max|
|Starting TNC x 1010||7.46||3.26||6.95||2.1||18.0|
|Initial Viability (%)||97.60||2.74||99.0||86.9||100.0|
|CD34+ cells x 107 cells||Starting Count||59.71||41.09||47.85||7.3||208.0|
|Final CD34+ Yield (%)||66.06||20.25||65.00||29.9||125.6|
|Final CD34+ Purity (%)||93.03||8.31||96.65||61.5||99.8|
|CD3+ T cells x 108||Starting Count||179.45||69.80||168.50||55.00||362.00|
|Log10 CD3+ T cell Depletion||4.78||0.55||4.90||3.2||5.9|
|Final Viability (%)||96.57||3.84||97.70||74.0||100.0|
|Total CD34+ cells Infused/kg x 106||8.81||5.21||7.924||2.41||30.360|
|Total CD3+ cells Infused/kg x 106||0.015||0.020||0.0060||0.0011||0.08328|
Authorized by U.S. Federal Law for use in the treatment of patients with acute myeloid leukemia (AML) in first complete remission. The effectiveness of the device for this use has not been demonstrated.
Indications for Use
The CliniMACS® CD34 Reagent System is indicated for processing hematopoietic progenitor cells collected by apheresis (HPC, Apheresis) from an allogeneic, HLA-identical, sibling donor to obtain a CD34+ cell-enriched population for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft versus host disease (GVHD) prophylaxis in patients with acute myeloid leukemia (AML) in first morphologic complete remission.
Do not use CD34+ cells prepared with CliniMACS CD34 Reagent System in patients with known hypersensitivity to murine (mouse) proteins or iron dextran.