A study to evaluate the safety of immune cell therapy in early transplant period of hematopoietic stem cell transplant recipients

Not Applicable

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

• Registration Number: KCT0004024
• 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: 17 June 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1) Patients between ages 17 and 70 years old
2) Lymphoma patients who are expecting an autologous hematopoeitic stem cell transplantation
3) ECOG performance status 0 or 1
4) Those who are considered to survive longer than 3 months
5) Those without acute infectious disease
6) Those who do not have comorbid tumor
7) Patients who voluntarily signed the informed consent form.

Exclusion Criteria

1) Pregnant women, lactating women, or women who have the possibility of pregnancy or those who have not taken adequate contraceptive measures
2) Sexually active men who do not take proper contraceptive measures
3) Patients with active infection or fever (=38 ?) with unknown etiology or ongoing bacterial or fungal infections
4) Patients under 19 or over 70 years old
5) ECOG performance status 2, 3, 4
6) Patients with previously proven HIV infection, uncontrolled hypertension (diastolic blood pressure> 115 mmHg), unstable angina, congestive heart failure (NY class II or higher), poorly controlled severe diabetes, coronary angioplasty within 6 months, Patients with acute myocardial infarction or non-malignant disease including uncontrolled atrial or ventricular arrhythmia within the past 6 months
7) Patients with mental illness, drug addiction, etc. who are judged to have an influence on the outcome of the study
8) Patients participating in other clinical trials
9) Patients who are judged to be inadequate for a clinical trial by the principal investigator
10) Other serious medical conditions that may reduce compliance with clinical trials

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Safety of cytokine-induced killer cell infusion following autologous hematopoeitic stem cell transplantation;2 year- disease free survival of autologous hematopoetic stem cell transplantation

Secondary Outcome Measures

Name	Time	Method
2 year- overall survival of autologous hematopoetic stem cell transplantation;Immunological biomarker analysis after cytokine-induced killer cell infusion;Hematological recovery after cytokine-induced killer cell infusion;Incidence of various latent viruses (CMV, ADV, EBV, BKV, HHV-6) reactivation and infection during early transplant period following cytokine-induced killer cell infusion