Randomized Study of Haploidentical Hct and Subsequent Donor nk Cell Infusion in High-risk AML and MDS (DNKI-4)
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|ClinicalTrials.gov Identifier: NCT02477787|
Recruitment Status : Terminated (upon recommendation from the Data Monitoring Committee)
First Posted : June 23, 2015
Last Update Posted : July 8, 2019
This is a single center, open label, random comparison phase 2b study. The primary objective of this study is, by random comparison, to assess the anti-leukemia effect of allogeneic, donor-derived natural killer (NK) cells infused after HLA-haploidentical hematopoietic cell transplantation (HCT) in patients with refractory acute myelogenous leukemia (AML).
The secondary objectives of the study are to assess the side effects of donor NK cell infusion, effects of donor NK cell infusion upon HCT outcomes, as well as effects upon post-HCT immune recovery.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia||Biological: allogeneic, donor-derived NK cells||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Comparative Study for Efficacy and Safety Evaluation of HLA-haploidentical Hematopoietic Cell Transplantation With or Without Post-transplant Allogeneic Donor-derived Natural Killer Cell Infusion in High-risk Acute Myelogenous Leukemia and Myelodysplastic Syndrome|
|Actual Study Start Date :||June 2015|
|Actual Primary Completion Date :||June 2019|
|Actual Study Completion Date :||June 2019|
patients will receive donor-derived NK cell infusion after haploidentical HCT
Biological: allogeneic, donor-derived NK cells
Patients in the study arm will receive donor NK cell infusion around days 13 and 20. A permissible range of infusion time will be +/- 3 days.
For DNKI to be given on day 13 (DNKI-1), the cell dose is 1-2 x108/kg or about the half of amount generated. For DNKI to be given on day 20 (DNKI-2), the cell dose is up to 5x108/kg.
Avil 1 ampoule will be given intravenously 30 minutes prior to each NK cell infusions.
No Intervention: control
patients will undergo haploidentical HCT but not receive donor-derived NK cells after HCT
- number of patients who experience progression/recurrence of AML after HCT [ Time Frame: up to 60 months ]
- number of patients who achieve engraftment after HCT [ Time Frame: up to 6 months ]
- number of patients who develop acute GVHD [ Time Frame: up to 4 months ]
- number of patients who develop chronic GVHD [ Time Frame: up to 60 months ]
- number of patients who experience donor NK cell infusion-associated toxicity [ Time Frame: up to 1 month ]
- number of patients who die after HCT without progression of AML [ Time Frame: up to 60 months ]
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): NCT02477787
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of|