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

• Status: Completed
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborator: Hanusk Krankenhaus Wien
• Treatments: Cytarabine; Etoposide; Etoposide phosphate; Melphalan

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