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Safety and Efficacy Study of Donor Natural Killer Cells Given After Haploidentical Hematopoietic Cell Transplantation (DNKI-II)

Primary Purpose

Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

donor natural killer cell infusion

About this trial

This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring acute myelogenous leukemia, acute lymphoblastic leukemia, donor natural killer cells, HLA-haploidentical hematopoietic cell transplantation

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with acute leukemia, which are refractory to standard treatment. Patients should be 17 years of age or older. The performance status of the patients should be 70 or over by Karnofsky scale. Patients should not have excessive hepatic dysfunction (bilirubin less than 3.0 mg/dl, AST less than 5 times the upper normal limit).

Patients should not have excessive renal dysfunction (creatinine less than 3.0 mg/dl).

Patients should not have clinically-evident cardiac or pulmonary dysfunction. Patients and donors must sign informed consent.

Exclusion Criteria:

Patients who are pregnant or lactating are not eligible.

Sites / Locations

Asan Medical Center

Outcomes

Primary Outcome Measures

occurrence and severity of side effects of donor natural killer cell infusion

Secondary Outcome Measures

anti-leukemia effect of donor natural killer cell infusion

Full Information

NCT ID

NCT01795378

First Posted

February 18, 2013

Last Updated

December 29, 2015

Sponsor

Asan Medical Center

Collaborators

Korea Research Institute of Bioscience & Biotechnology

1. Study Identification

Unique Protocol Identification Number

NCT01795378

Brief Title

Safety and Efficacy Study of Donor Natural Killer Cells Given After Haploidentical Hematopoietic Cell Transplantation

Acronym

DNKI-II

Official Title

HLA-Haploidentical Hematopoietic Cell Transplantation and Subsequent Donor Natural Killer Cell Infusion in Refractory Acute Leukemia - A Phase 1-2a STUDY

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asan Medical Center

Collaborators

Korea Research Institute of Bioscience & Biotechnology

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The protocol treatment is to evaluate clinical effects of donor-derived natural killer cells that are given after HLA-mismatched hematopoietic cell transplantation.

Detailed Description

Those patients with acute leukemia, which is not responding to coventional chemotherapy, will be treated. The clinical effects will be evaulated in terms of safety (side effects) and anti-leukemia effect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia

Keywords

acute myelogenous leukemia, acute lymphoblastic leukemia, donor natural killer cells, HLA-haploidentical hematopoietic cell transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

donor natural killer cell infusion

Intervention Description

Donor NK cells will be generated at the GCP laboratory at Asan Institute of Life Science by a team from Stem Cell Research Center, Korea Research Institute of Bioscience and Biotechnology. The patients will receive donor NK cell infusion (DNKI) around on days 6 and 9 (generated from the first collection), and around on days 13 and 20 (generated from the second collection). For DNKI to be given on days 6 and 9, a 3-patient cohort each will receive escalating dose of 2x10e7/kg, 5x10e7/kg, 1x10e8/kg, and 1-4 x10e8 cells. The dose of DNKI to be given on days 13 and 20 will be 1-4 x10e8/kg.

Primary Outcome Measure Information:

Title

occurrence and severity of side effects of donor natural killer cell infusion

Time Frame

1 year

Secondary Outcome Measure Information:

Title

anti-leukemia effect of donor natural killer cell infusion

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with acute leukemia, which are refractory to standard treatment. Patients should be 17 years of age or older. The performance status of the patients should be 70 or over by Karnofsky scale. Patients should not have excessive hepatic dysfunction (bilirubin less than 3.0 mg/dl, AST less than 5 times the upper normal limit). Patients should not have excessive renal dysfunction (creatinine less than 3.0 mg/dl). Patients should not have clinically-evident cardiac or pulmonary dysfunction. Patients and donors must sign informed consent. Exclusion Criteria: Patients who are pregnant or lactating are not eligible.

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

21715313

Citation

Lee KH, Lee JH, Lee JH, Kim DY, Seol M, Lee YS, Kang YA, Jeon M, Hwang HJ, Jung AR, Kim SH, Yun SC, Shin HJ. Reduced-intensity conditioning therapy with busulfan, fludarabine, and antithymocyte globulin for HLA-haploidentical hematopoietic cell transplantation in acute leukemia and myelodysplastic syndrome. Blood. 2011 Sep 1;118(9):2609-17. doi: 10.1182/blood-2011-02-339838. Epub 2011 Jun 28.

Results Reference

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PubMed Identifier

19881555

Citation

Yoon SR, Lee YS, Yang SH, Ahn KH, Lee JH, Lee JH, Kim DY, Kang YA, Jeon M, Seol M, Ryu SG, Chung JW, Choi I, Lee KH. Generation of donor natural killer cells from CD34(+) progenitor cells and subsequent infusion after HLA-mismatched allogeneic hematopoietic cell transplantation: a feasibility study. Bone Marrow Transplant. 2010 Jun;45(6):1038-46. doi: 10.1038/bmt.2009.304. Epub 2009 Nov 2.

Results Reference

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Safety and Efficacy Study of Donor Natural Killer Cells Given After Haploidentical Hematopoietic Cell Transplantation

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