NK Cell Based Non-Myeloablative Transplantation in Acute Myeloid Diseases
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|