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

Sponsor

Asan Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01795378

Collaborator

Korea Research Institute of Bioscience & Biotechnology (Other)

Enrollment

Location

26.9

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia	Biological: donor natural killer cell infusion	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 1, 2015

Outcome Measures

Primary Outcome Measures

occurrence and severity of side effects of donor natural killer cell infusion [1 year]

Secondary Outcome Measures

anti-leukemia effect of donor natural killer cell infusion [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years and Older

Sexes Eligible for Study:

All

Accepts 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.