Status:
COMPLETED
A Trial Comparing the Two High-dose Chemotherapies BeEAM and BEAM Given Before Autologous Stem Cell Transplantation (ASCT) in Lymphoma Patients (BEB-trial)
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Hanusk Krankenhaus Wien
Conditions:
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Follicular
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 tog...
Detailed Description
Background High-dose chemotherapy (HDCT) followed by autologous stem cell transplantation (ASCT) is considered the treatment of choice for relapsed/refractory lymphomas. On the basis of the results o...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2020
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT02278796
Start Date
April 1 2015
End Date
November 1 2020
Last Update
August 1 2025
Active Locations (4)
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1
Krankenhaus der Elisabethinen Linz
Linz, Austria, 4020
2
Hanusch Krankenhaus Wien
Vienna, Austria, 1140
3
Department for Medical Oncology University Hospital/Inselspital
Bern, Switzerland, 3010
4
Universitätsspital Zürich
Zurich, Switzerland, 8091