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BeEAC Conditioning Regimen in Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation (BeEAC-1)

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ClinicalTrials.gov Identifier: NCT03315520
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

Tracking Information
First Submitted Date  ICMJE September 26, 2017
First Posted Date  ICMJE October 20, 2017
Last Update Posted Date May 22, 2018
Actual Study Start Date  ICMJE January 22, 2016
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2017)
Incidence of Treatment-Emergent Adverse Events [ Time Frame: From admission till discharge from the hospital (approximately 30 days) ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
Incidence of Treatment-Emergent Adverse Events [ Time Frame: From admission till discharge from the hospital (approximately 30 days) ]
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 experiencies 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).
Change History Complete list of historical versions of study NCT03315520 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2017)
  • Overall Survival [ Time Frame: 2 years ]
  • Progression-Free Survival [ Time Frame: 2 years ]
  • Retrospective Comparison of Overall Survival between Carmustine, Etoposide, Cytarabine, Melphalan (BEAM), Cyclophosphamide, Carmustine, Etoposide(CBV) and BeEAC conditioning regimens [ Time Frame: 2 years ]
    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 [ Time Frame: 2 years ]
    The analysis will be based on comparison of Progression-Free survival between different conditioning regimens
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
  • Overall Survival [ Time Frame: 2 years ]
  • Progression-Free Survival [ Time Frame: 2 years ]
  • Retrospective Comparison of Overall Survival between BEAM (Carmustine, Etoposide, Cytarabine, Melphalan), CBV (Cyclophosphamide, Carmustine, Etoposide) and BeEAC conditioning regimens [ Time Frame: 2 years ]
    The analysis will be based on comparison of overall sirvival between different conditioning regimens
  • Retrospective Comparison of Progression-Free Survival between BEAM (Carmustine, Etoposide, Cytarabine, Melphalan), CBV (Cyclophosphamide, Carmustine, Etoposide) and BeEAC conditioning regimens [ Time Frame: 2 years ]
    The analysis will be based on comparison of Progression-Free sirvival between different conditioning regimens
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BeEAC Conditioning Regimen in Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed/Refractory Malignant Lymphomas
Intervention  ICMJE Drug: Bendamustine

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)

Other Names:
  • Cytarabine
  • Etoposide
  • Cyclophosphamide
Study Arms  ICMJE Experimental: Relapsed/refractory malignant lymphomas
Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation using BeEAC (Bendamustine, Cytarabine, Etoposide, Cyclophosphamide) conditioning regimen
Intervention: Drug: Bendamustine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 16, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vladislav Sarzhevskiy, MD, PhD +74956037217 vladsar100@gmail.com
Contact: Nikita Mochkin, MD, PhD +74956037217 nickmed@yandex.ru
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03315520
Other Study ID Numbers  ICMJE BeEAC-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Study Sponsor  ICMJE State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vladislav Sarzhevskiy, MD, PhD
PRS Account State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP