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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

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.


Condition or disease Intervention/treatment Phase
Relapsed/Refractory Malignant Lymphomas Drug: Bendamustine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 22, 2016
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Relapsed/refractory malignant lymphomas
Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation using BeEAC (Bendamustine, Cytarabine, Etoposide, Cyclophosphamide) conditioning regimen
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




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years ]
  2. Progression-Free Survival [ Time Frame: 2 years ]
  3. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315520


Contacts
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Contact: Vladislav Sarzhevskiy, MD, PhD +74956037217 vladsar100@gmail.com
Contact: Nikita Mochkin, MD, PhD +74956037217 nickmed@yandex.ru

Locations
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Russian Federation
The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation Recruiting
Moscow, Russian Federation, 105203
Contact: Vladislav Sarzhevskiy, MD, PhD    +74956037217    vladsar100@gmail.com   
Contact: Nikita Mochkin, MD, PhD    +74956037217    nickmed@yandex.ru   
Sponsors and Collaborators
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Investigators
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Principal Investigator: Vladislav Sarzhevskiy, MD, PhD

Publications:

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Responsible Party: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
ClinicalTrials.gov Identifier: NCT03315520     History of Changes
Other Study ID Numbers: BeEAC-1
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia:
Hodgkin Lymphoma
Non-Hodgkin lymphoma
autologous hematopoietic stem-cell transplantation
conditioning regimen

Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Cytarabine
Bendamustine Hydrochloride
Etoposide
Etoposide phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents