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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 : Recruiting
First Posted : June 23, 2015
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Kyoo-Hyung Lee, Asan Medical Center

Brief Summary:

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: treatment
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



Primary Outcome Measures :
  1. number of patients who experience progression/recurrence of AML after HCT [ Time Frame: up to 60 months ]

Secondary Outcome Measures :
  1. number of patients who achieve engraftment after HCT [ Time Frame: up to 6 months ]
  2. number of patients who develop acute GVHD [ Time Frame: up to 4 months ]
  3. number of patients who develop chronic GVHD [ Time Frame: up to 60 months ]
  4. number of patients who experience donor NK cell infusion-associated toxicity [ Time Frame: up to 1 month ]
  5. number of patients who die after HCT without progression of AML [ Time Frame: up to 60 months ]


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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with refractory AML Refractory AML is defined as follows;

    1. Primary refractory: failure to achieve complete remission (CR) after 2 cycles of induction chemotherapy; or, in patient ≥65 years of age, progressive AML after treatment with hypomethylating agent (increase in peripheral blood blast by 50% or increase in bone marrow blast by 25%)
    2. Relapse then refractory: recurrence of AML, which is refractory to standard salvage chemo therapy; or, in patient ≥65 years of age, to hypomethylating agent
    3. AML in ≥2 relapses
  • Patients should be 19 years of age or older
  • Patients should have Karnofsky performance scale ≥70
  • Patients and cell donors must understand fully and sign informed consent forms

Exclusion Criteria:

  • Pregnant or lactating women
  • Patient with abnormal liver function (total bilirubin ≥ 5.0 mg/dl, AST ≥ 5 times upper normal limits)
  • Patients with abnormal renal function (creatinine ≥ 3.0 mg/dl)
  • Patients with clinically-evident cardiac or pulmonary dysfunction
  • Patients with infection that is progressive despite appropriate anti-microbial treatment
  • Patients with hypersensitivity to gentamicin
  • Patients who had received allogeneic cell therapy previously.

Information from the National Library of Medicine

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


Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Kyoo-Hyung Lee, MD    82-2-3010-3213    khlee2@amc.seoul.kr   
Contact: Inpyo Choi, PhD    82-42-860-4223    ipchoi@kribb.re.kr   
Sponsors and Collaborators
Asan Medical Center

Responsible Party: Kyoo-Hyung Lee, MD, PROFESSOR, HEMATOLOGY, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02477787     History of Changes
Other Study ID Numbers: 2014-1091
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

Keywords provided by Kyoo-Hyung Lee, Asan Medical Center:
HLA-haploidentical hematopoietic cell transplantation
natural killer cells

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms