Overview

Rituximab and DexaBEAM as Salvage Therapy for Relapsed Lymphoma

Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
0
Participant gender:
All
Summary
The investigator prospectively evaluated the combination of Rituximab and Dexa-BEAM (dexamethasone, carmustine, etoposide, cytarabine, melphalan) followed by high dose therapy in patients with relapsed/refractory aggressive and indolent lymphoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Georg Hess, MD
Collaborators:
Department of Hematology Krankenhaus Höchst Frankfurt
Klinikum Frankfurt Höchst
Roche Pharma AG
Treatments:
Carmustine
Cytarabine
Dexamethasone
Etoposide
Melphalan
Rituximab
Criteria
Inclusion Criteria:

- age between 18 and 65 years

- Patients with aggressive B-cell-lymphoma:diffuse large B-cell lymphoma (DLBCL), mantle
cell lymphoma (MCL) or grade IIIB follicular lymphoma (FL) with relapse after complete
remission (CR) or failure to achieve CR on treatment.

- Patients with indolent lymphoma: FL grade I-IIIA, marginal zone lymphoma (MZL) and
immunocytoma (IC) if relapsed or failure to achieve at least partial remission (PR) on
treatment.

- CD20 positive

- previous therapy: at least 3 cycles of anthracycline containing regimens.

- ECOG (Eastern Cooperative Oncology Group) 0-2

- measurable disease

- adequate bone marrow function (absolute neutrophil count [ANC] >1500/µl; platelet
count >100,000/µl), unless there was clear evidence of bone marrow involvement

- glomerular filtration rate > 60ml/min

- ASAT(aspartate transaminase)/ALAT(alanine aminotransferase) < 2.5-fold upper limit of
normal (ULN) unless associated with liver infiltration

- free from other cancers for at least 5 years, with the exception of basal cell
carcinoma and carcinoma in situ of the uterine cervix.

- given informed consent

Exclusion Criteria:

- (central nervous system) CNS-lymphoma

- HIV

- Hepatitis B or C

- pregnancy

- breast-feeding women

- high dose therapy or allogeneic transplantation

- glomerular filtration rate < 60ml/min

- ASAT/ALAT > 2.5-fold upper limit of normal (ULN) unless associated with liver
infiltration