Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT03315520
Eligibility Criteria:
Inclusion Criteria:
1. Be willing and able to provide written informed consent for the trial
2. Be ≥ 18 years of age on day of signing informed consent
3. Eastern Cooperative Oncology Group (ECOG) \< 2.
4. Relapsed/refractory malignant lymphoma patients with indications to autologous hematopoietic stem-cell transplantation
Exclusion Criteria:
1. Participation in another clinical trials
2. Clinically relevant heart disease:
* Myocardial infarction during previous 6 months
* Unstable angina during previous 3 months
* Congestive heart failure (III-IV NYHA)
* Clinically relevant ventricular arrhythmias
* corrected QT interval (QTc) \> 460 мс on ECG (calculated using Frederics formula)
* Left ventricular ejection fraction ≤ 45% on Echocardiogram
* Atrial Hypotension (systolic pressure \< 86 mmHg) or bradycardia (\< 50 per minute, exclusion - drug-induced bradycardia)
* Uncontrolled arterial hypertension (systolic pressure \> 170 mmHg or diastolic pressure \> 105 mmHg)
3. Severe renal dysfunction (serum creatinine \> 250 µmol/l)
4. Severe hepatic dysfunction (total bilirubin \> 40 µmol/l)
5. Known history of Human Immunodeficiency Virus or active Hepatitis B and C
6. Psychiatric or substance abuse disorders that would interfere with the cooperation with the requirements of the trial
7. Hypersensitivity to investigational drugs
8. Pregnant or breastfeeding females or males and females with childbearing potential must be willing to use an adequate method of birth control (intrauterine device, vasectomy of female subjects' male partner, contraceptive rod implanted into the skin, combination method - (requires use of two of the following) diaphragm with spermicide, cervical cap spermicide, contraceptive sponge, condom, hormonal contraceptive)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03315520
Study Brief:
Protocol Section:
NCT03315520