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

Sponsor
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia (Other)
Overall Status
Unknown status
CT.gov ID
NCT03315520
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
59.3
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
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 :
Jan 22, 2016
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Treatment-Emergent Adverse Events [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 [2 years]

    2. Progression-Free Survival [2 years]

    3. Retrospective Comparison of Overall Survival between Carmustine, Etoposide, Cytarabine, Melphalan (BEAM), Cyclophosphamide, Carmustine, Etoposide(CBV) and BeEAC conditioning regimens [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 [2 years]

      The analysis will be based on comparison of Progression-Free survival between different conditioning regimens

    Eligibility Criteria

    Criteria

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

    1. Severe renal dysfunction (serum creatinine > 250 µmol/l)

    2. Severe hepatic dysfunction (total bilirubin > 40 µmol/l)

    3. Known history of Human Immunodeficiency Virus or active Hepatitis B and C

    4. Psychiatric or substance abuse disorders that would interfere with the cooperation with the requirements of the trial

    5. Hypersensitivity to investigational drugs

    6. 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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 Russian Federation 105203

    Sponsors and Collaborators

    • State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

    Investigators

    • Principal Investigator: Vladislav Sarzhevskiy, MD, PhD,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
    ClinicalTrials.gov Identifier:
    NCT03315520
    Other Study ID Numbers:
    • BeEAC-1
    First Posted:
    Oct 20, 2017
    Last Update Posted:
    May 22, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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:
    Lymphoma
    Cytarabine
    Cyclophosphamide
    Bendamustine Hydrochloride
    Etoposide

    Study Results

    No Results Posted as of May 22, 2018