A randomized (means treatment not decided by physician but by change per computer) phase II trial for lymphoma patient comparing established chemotherapy combination BEAM (BCNU, cytarabine, etoposide, melphalan) with new combination replacing BCNU by bendamustine (BeEAM) for conditioning treatment prior to transplantation with own stem cells (autologous stem cell transplantation).
- Conditions
- Chemosensitive diffuse large B-cell lymphomas (DLBCL), follicular lymphomas (FL), and mantle cell lymphomas (MCL) in first or second remissionTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2014-003629-16-AT
- Lead Sponsor
- niversity Hospital/Inselspital Berne, Department for Medical Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 108
• Informed Consent as documented by signature (Appendix Informed Consent Form)
• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54
• Acute uncontrolled infection
• Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) excluding a treatment according to this protocol
• HCTCI (hematopoietic cell transplantation comorbidity index) > 5 (Use Dinakara equation for adjusting DLCO for hemoglobin)
• Concurrent malignant disease with the exception of basalioma/spinalioma of the skin or early-stage cervix carcinoma or early-stage prostate cancer. Previous treatment for other malignancies (not listed above) must have been terminated at least 24 months before registration and no evidence of active disease must be documented since then.
• Known or suspected non-compliance excluding participation to the treatment as outlined in this protocol
• 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, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Female participants who are surgically sterilized / hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method