Back to resultsBeEAC Conditioning Regimen in Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation (BeEAC-1)
Primary Purpose
Relapsed/Refractory Malignant Lymphomas
Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Bendamustine
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed/Refractory Malignant Lymphomas focused on measuring Hodgkin Lymphoma, Non-Hodgkin lymphoma, autologous hematopoietic stem-cell transplantation, conditioning regimen
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Sites / Locations
- The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian FederationRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Relapsed/refractory malignant lymphomas
Arm Description
Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation using BeEAC (Bendamustine, Cytarabine, Etoposide, Cyclophosphamide) conditioning regimen
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events
The primary safety analysis will be based on subjects who experienced toxicities as defined by CTCAE criteria. Safety will be assessed by quantifying the toxicities and grades experienced by subjects who have received BeEAC including serious adverse events (SAEs).
Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE 4.03. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taking with regard to trial treatment (Incidence of Treatment-Emergent Adverse Events).
Secondary Outcome Measures
Overall Survival
Progression-Free Survival
Retrospective Comparison of Overall Survival between Carmustine, Etoposide, Cytarabine, Melphalan (BEAM), Cyclophosphamide, Carmustine, Etoposide(CBV) and BeEAC conditioning regimens
The analysis will be based on comparison of overall survival between different conditioning regimens
Retrospective Comparison of Progression-Free Survival between Carmustine, Etoposide, Cytarabine, Melphalan (BEAM), Cyclophosphamide, Carmustine, Etoposide(CBV) and BeEAC conditioning regimens
The analysis will be based on comparison of Progression-Free survival between different conditioning regimens
Full Information
NCT ID
NCT03315520
First Posted
September 26, 2017
Last Updated
May 21, 2018
Sponsor
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
1. Study Identification
Unique Protocol Identification Number
NCT03315520
Brief Title
BeEAC Conditioning Regimen in Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation
Acronym
BeEAC-1
Official Title
A Phase II, Multicenter, Prospective, Non-randomised, Open-label, Clinical Trial to Evaluate Effectiveness and Safety of BeEAC Conditioning Regimen in Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 22, 2016 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 action of nitrogen mustard and the activity of purine antimetabolite. Bendamustine has shown its effectiveness for the treatment of patients with chronic lymphoproliferative diseases such as chronic lymphocytic leukemia and several indolent lymphomas. The literature also presents evidence of the effectiveness bendamustine in patients with Hodgkin's lymphoma who received multiple lines of prior chemotherapy, including high dose chemotherapy and transplantation of peripheral hematopoietic stem cells. There are also data of using bendamustine as a part of conditioning regimen.
In this context, it was planned a study for evaluation the safety and effectiveness of the BeEAC (bendamustine, etoposide, cytarabine, cyclophosphamide) conditioning regimen prior to autologous transplantation of peripheral hematopoietic stem cells for the treatment of relapsed/refractory malignant lymphomas.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Malignant Lymphomas
Keywords
Hodgkin Lymphoma, Non-Hodgkin lymphoma, autologous hematopoietic stem-cell transplantation, conditioning regimen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Relapsed/refractory malignant lymphomas
Arm Type
Experimental
Arm Description
Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation using BeEAC (Bendamustine, Cytarabine, Etoposide, Cyclophosphamide) conditioning regimen
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Cytarabine, Etoposide, Cyclophosphamide
Intervention Description
BeEAC conditioning regimen:
bendamustine 200 mg/м2 D-6 - D-5; cytarabine 400 mg/м2 D-4 - D-1; etoposide 400 mg/м2 D-4 - D-1; cyclophosphamide 140 mg/м2 totally, divided in 4 days (D-4 - D-1)
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
The primary safety analysis will be based on subjects who experienced toxicities as defined by CTCAE criteria. Safety will be assessed by quantifying the toxicities and grades experienced by subjects who have received BeEAC including serious adverse events (SAEs).
Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE 4.03. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taking with regard to trial treatment (Incidence of Treatment-Emergent Adverse Events).
Time Frame
From admission till discharge from the hospital (approximately 30 days)
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
2 years
Title
Progression-Free Survival
Time Frame
2 years
Title
Retrospective Comparison of Overall Survival between Carmustine, Etoposide, Cytarabine, Melphalan (BEAM), Cyclophosphamide, Carmustine, Etoposide(CBV) and BeEAC conditioning regimens
Description
The analysis will be based on comparison of overall survival between different conditioning regimens
Time Frame
2 years
Title
Retrospective Comparison of Progression-Free Survival between Carmustine, Etoposide, Cytarabine, Melphalan (BEAM), Cyclophosphamide, Carmustine, Etoposide(CBV) and BeEAC conditioning regimens
Description
The analysis will be based on comparison of Progression-Free survival between different conditioning regimens
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vladislav Sarzhevskiy, MD, PhD
Phone
+74956037217
Email
vladsar100@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nikita Mochkin, MD, PhD
Phone
+74956037217
Email
nickmed@yandex.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladislav Sarzhevskiy, MD, PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
City
Moscow
ZIP/Postal Code
105203
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladislav Sarzhevskiy, MD, PhD
Phone
+74956037217
Email
vladsar100@gmail.com
First Name & Middle Initial & Last Name & Degree
Nikita Mochkin, MD, PhD
Phone
+74956037217
Email
nickmed@yandex.ru
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
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BeEAC Conditioning Regimen in Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation
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