Effect of the safety and recurrence of WT1- specific cytotoxic T lymphocytes (CTL) therapy in the treatment of high-risk acute myeloid leukemia, myelodysplastic syndrome

Not Applicable

Completed

• Conditions: Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism

• Registration Number: KCT0002515
• Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Patients matching all of the following were included:
1) Corresponds to study the disease, HLA match for siblings, parents, and children.
2) WT1 antigen expression in malignant cells
3) Patients who are at least 14 years old up to 75 years old
4) Eastern Cooperative Oncology Group (ECOG) performance rating of 0, 1, 2
5) Patients with adequate kidney function (serum creatinine less than 1.5 times the normal upper limit)
6) Patients with adequate liver function (bilirubin less than 1.5 times the normal upper limit in the serum)
7) Patients with adequate heart function (there should be no specific electrocardiographic findings according to the principal investigator's judgment)
8) No evidence of secondary tumor, heart failure, infection chronic lung disease ultimately according to the principal investigator's judgment.
9) Voluntarily signed the informed patient consent

Exclusion Criteria

Patients with any of the following were excluded from the study:
1) Pregnancy, lactation or potential of pregnancy
2) Bacterial or fungal infection of unknown cause or patients with fever (=38?) or active infection in progress
3) Patients under 14 years old or over 75 years old
4) Eastern Cooperative Oncology Group (ECOG) performance rating of 3, 4
5) Previously demonstrated human immunodeficiency virus (HIV) infection, hypertension (diastolic blood pressure >115mmHg), unstable angina, congestive heart failure (NY class II or higher), severe diabetes that is not well controlled, coronary angioplasty within the last 6 months, patients with acute myocardial infarction or non-malignant diseases including atrial ventricular arrhythima within the past six months
6)Patients with a mental disorder or substance abuse that is considered to affect the results of the research
7) Patients participating in another clinical trial
8) Patients with other serious medical conditions.
9) Patients who did not achieve complete response following inital therapy, including chemotherapy and/or radiotherapy, salvage therapy, or high-dose therapy and stem cell transplantation.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
We determined the safety of administered WT1 specific CTLs following treatment. ;We determined the efficacy of administered WT1 specific CTLs following treatment for one years to determine the disease-free survival.