Status:
UNKNOWN
BeEAC Conditioning Regimen in Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation
Lead Sponsor:
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Conditions:
Relapsed/Refractory Malignant Lymphomas
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Nowadays there is no randomized trials for comparison the effectiveness and tolerability of different conditioning regimens. Bendamustine is a unique chemotherapeutic agent that combines alkylating a...
Eligibility Criteria
Inclusion
- Be willing and able to provide written informed consent for the trial
- Be ≥ 18 years of age on day of signing informed consent
- Eastern Cooperative Oncology Group (ECOG) \< 2.
- Relapsed/refractory malignant lymphoma patients with indications to autologous hematopoietic stem-cell transplantation
Exclusion
- Participation in another clinical trials
- 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)
- Severe renal dysfunction (serum creatinine \> 250 µmol/l)
- Severe hepatic dysfunction (total bilirubin \> 40 µmol/l)
- Known history of Human Immunodeficiency Virus or active Hepatitis B and C
- Psychiatric or substance abuse disorders that would interfere with the cooperation with the requirements of the trial
- Hypersensitivity to investigational drugs
- 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)
Key Trial Info
Start Date :
January 22 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03315520
Start Date
January 22 2016
End Date
December 31 2020
Last Update
May 22 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
Moscow, Russia, 105203