NK Cell Based Non-Myeloablative Transplantation in Acute Myeloid Diseases
|ClinicalTrials.gov Identifier: NCT01370213|
Recruitment Status : Active, not recruiting
First Posted : June 9, 2011
Last Update Posted : March 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Myelodysplastic Syndrome||Drug: Preparative Regimen Biological: NK Cells Drug: Interleukin-2 Biological: Anti-thymocyte globulin Biological: Donor TCR α/β-depleted Cells||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-Center Phase II Trial of NK Cell Based Non-Myeloablative Haploidentical Transplantation for Patients With High-Risk Acute Myeloid Diseases|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2019|
Experimental: High-Risk Acute Myeloid Disease
Patients with high risk acute myeloid disease treated with preparative regimen including Fludara, Cytoxan and total body irradiation followed by haploidentical donor NK cells, Interleukin-2, rabbit anti-thymocyte globulin, and same donor TCR α/β-depleted cells infusion.
Drug: Preparative Regimen
1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant, 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pretransplant, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pretransplant,
Other Names:Biological: NK Cells
CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pretransplant.
Other Name: Natural Killer cellsDrug: Interleukin-2
Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion
Other Name: IL-2Biological: Anti-thymocyte globulin
rabbit anti-thymocyte globulin will be administered on day -5 (0.5 mg/kg) and day -4 (2.5 mg/kg) pretransplant per institutional guidelines
Other Name: ATGBiological: Donor TCR α/β-depleted Cells
Single donor TCR α/β-depleted filgrastim-mobilized peripheral blood stem cells (PBSC) graft (minimum cell dose of 5 x 10^6/kg) on day 0
Other Name: stem cell graft
- Rate of Donor Neutrophil Engraftment [ Time Frame: Day 28 ]The rate of donor neutrophil engraftment in the absence of leukemia at day +28 will be determined. Successful neutrophil engraftment is defined as an absolute donor-derived neutrophil count of >500 cells/μl. Leukemia free is defined as <5% bone marrow blasts, absence of blasts with Auer rods; absence of extramedullary disease; but cytogenetic or molecular minimal residual disease is allowed.
- Disease Free Survival [ Time Frame: At 6 Months ]
- Treatment Related Mortality (TRM) [ Time Frame: At 6 Months ]Cumulative incidence will be used to estimate TRM.
- Incidence of Relapse [ Time Frame: 2 Years ]Cumulative incidence will be used to estimate relapse.
- Rate of Early In Vivo Expansion of Natural Killer (NK) Cells [ Time Frame: Day 0 ]Successful in vivo donor NK cell expansion will be defined by measuring an absolute circulating donor-derived NK cell count of >100 cells/μl in patient's peripheral blood 12 days after infusion.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370213
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Minnesota|
|University of Minnesota, Masonic Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Sarah Cooley, M.D.||Masonic Cancer Center, University of Minnesota|