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A Trial Comparing the Two High-dose Chemotherapies BeEAM and BEAM Given Before Autologous Stem Cell Transplantation (ASCT) in Lymphoma Patients (BEB-trial) (BEB)

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ClinicalTrials.gov Identifier: NCT02278796
Recruitment Status : Active, not recruiting
First Posted : October 30, 2014
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
Hanusk Krankenhaus Wien
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:
In the treatment of patient with lymphoma the most common high-dose chemotherapy regimen used prior to autologous transplantation (ASCT) is the BEAM regimen. It consists of four chemotherapy drugs together (BCNU, etoposide, cyclophosphamide, melphalan), whose initial letters are grouped together for BEAM regimen. One of the most common organ damage this intensive treatment is caused by the drug BCNU; it involves a lung injury, which manifests itself in the months after ASCT with increasing shortness of breath and cough, and can result in pulmonary fibrosis. The drug bendamustine is used successfully in different lymphoma types, and its efficacy in lymphoma therapy is well documented. Moreover bendamustine doesn't cause lung injury. Initially experience with bendamustine instead of BCNU - in the so-called BeEAM scheme - shows that this scheme is quite effective and well tolerated, without lung injury. In BeEAM scheme therefore bendamustine replace the BCNU, while the other three drugs are administered in the same dosage and order. The aim of the present study conducted at four centers (Bern and Zurich in Switzerland, Vienna and Linz in Austria) is to compare these two high-dose chemotherapy schemas and to show that the BeEAM scheme causes significantly less lung injury than the BEAM regimen.

Condition or disease Intervention/treatment Phase
Lymphoma, Large B-Cell, Diffuse Lymphoma, Follicular Lymphoma, Mantle-Cell Drug: BeEAM Drug: BEAM Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial Comparing BeEAM With BEAM as Conditioning Regimen for Autologous Stem Cell Transplantation (ASCT) in Lymphoma Patients (BEB-trial)
Actual Study Start Date : April 2015
Actual Primary Completion Date : November 28, 2018
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: BeEAM
Chemotherapy regimen consisting of bendamustine intravenously on days −7 and −6 at 200 mg/m2; cytarabine, 400 mg/m2 intravenously daily from day −5 to day−2; etoposide, 200 mg/m2 intravenously daily from day −5 to day −2; and melphalan, 140 mg/m2 intravenously on day −1 before reinfusion of autologous stem cells
Drug: BeEAM
Chemotherapy regimen consisting of bendamustine intravenously on days −7 and −6 at 200 mg/m2; cytarabine, 400 mg/m2 intravenously daily from day −5 to day−2; etoposide, 200 mg/m2 intravenously daily from day −5 to day −2; and melphalan, 140 mg/m2 intravenously on day −1 before reinfusion of autologous stem cells

Active Comparator: BEAM
Chemotherapy regimen with carmustine (BCNU) 300 mg/m2 on day -6, cytarabine, 400 mg/m2 intravenously daily from day −5 to day−2; etoposide, 200 mg/m2 intravenously daily from day −5 to day −2; and melphalan, 140 mg/m2 intravenously on day −1 before reinfusion of autologous stem cells
Drug: BEAM
Chemotherapy regimen with carmustine (BCNU) 300 mg/m2 on day -6, cytarabine, 400 mg/m2 intravenously daily from day −5 to day−2; etoposide, 200 mg/m2 intravenously daily from day −5 to day −2; and melphalan, 140 mg/m2 intravenously on day −1 before reinfusion of autologous stem cells




Primary Outcome Measures :
  1. Number of patients with a clinically meaningful reduction in lung toxicity, defined as a reduction of the diffusion capacity of the lung for carbon monoxide (DLCO) by at least 15%. [ Time Frame: At baseline ]
  2. Number of patients with a clinically meaningful reduction in lung toxicity, defined as a reduction of the diffusion capacity of the lung for carbon monoxide (DLCO) by at least 15%. [ Time Frame: 3 months after ASCT ]
  3. Number of patients with a clinically meaningful reduction in lung toxicity, defined as a reduction of the diffusion capacity of the lung for carbon monoxide (DLCO) by at least 15%. [ Time Frame: 12 months after ASCT ]

Secondary Outcome Measures :
  1. Number of patients with acute and late toxicity/adverse events (CTCAE4) [ Time Frame: Continuously up to 10 years ]
  2. Number of patients with hematologic recovery and engraftment [ Time Frame: 3 months after ASCT ]
  3. Change from baseline in ECHO/ECG [ Time Frame: 3 and 12 months after ASCT ]
  4. Change from baseline in quality of life [ Time Frame: 3 and 12 months after ASCT ]
    Measured by questionnaire

  5. Number of patients with overall survival [ Time Frame: At 12 months and yearly thereafter, up to 10 years ]
  6. Number of patients with progression free survival [ Time Frame: At 12 months and yearly thereafter, up to 10 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written Informed Consent
  • Chemosensitive diffuse large B-cell lymphomas (DLBCL), follicular lymphomas (FL), and mantle cell lymphomas (MCL) in first or second remission
  • Aged between 18 years and 75 years
  • Neutrophils ≥ 1000/μl; Platelets ≥ 100 x 109/L

Exclusion Criteria

  • Acute uncontrolled infection
  • Clinically significant concomitant disease states
  • Hematopoietic cell transplantation comorbidity index (HCT-CI) > 5
  • Previous or concurrent malignant disease with the exception of basalioma/spinalioma of the skin or early-stage cervix carcinoma
  • Known or suspected non-compliance
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • Major coagulopathy or bleeding disorder
  • Major surgery less than 30 days before start of treatment
  • Contraindications to the class of drugs under study, known hypersensitivity or allergy to class of drugs or the investigational product
  • Women who are pregnant or breast feeding; Women with the intention to become pregnant during the course of the study
  • Lack of safe contraception
  • Participation in another study with investigational drug within the 30 days preceding and during the present study
  • Previous enrolment into the current study
  • Enrolment of the investigator, his/her family members, employees and other dependent persons

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): NCT02278796


Locations
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Austria
Krankenhaus der Elisabethinen Linz
Linz, Austria, 4020
Hanusch Krankenhaus Wien
Wien, Austria, 1140
Switzerland
Department for Medical Oncology University Hospital/Inselspital
Berne, Switzerland, 3010
Universitätsspital Zürich
Zürich, Switzerland, 8091
Sponsors and Collaborators
University Hospital Inselspital, Berne
Hanusk Krankenhaus Wien
Investigators
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Study Chair: Thomas Pabst, Prof Dr. med Department for Medical Oncology University Hospital/Inselspital
Principal Investigator: Felix Keil, Prim. Univ. Prof. Dr Hanusch Krankenhaus Wien

Publications of Results:

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02278796    
Other Study ID Numbers: BEB-Trial
2014-003629-16 ( EudraCT Number )
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Keywords provided by University Hospital Inselspital, Berne:
Diffuse large B-cell lymphomas (DLBC)
Follicular lymphomas (FL)
Mantle cell lymphomas (MCL)
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Follicular
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Cytarabine
Etoposide
Etoposide phosphate
Melphalan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating