Aggressive non-Hodgkin's lymphomas (first line therapy)
Conditions
Interventions
Trade Name: Carmubris
Product Name: Carmustine
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: CARMUSTINE
Sponsors
Universitätsklinikum Essen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of aggressive non-Hodgkin's lymphoma B cell type diffuse large B cell lymphoma including variants and subtypes follicular lymphoma grade 3 T cell type anaplastic large T or 0 cell lymphoma angioimmunoblastic T cell lymphoma peripheral T cell lymphoma not otherwise specified intestinal T/NK cell lymphoma hepatosplenic gamma-delta T cell lymphoma subcutaneous panniculitis-like T cell lymphoma Pathological PET scan before treatment Performance status ECOG 0 - 3 Age 18 - 80 years Effective contraception Availability of patient for treatment and follow-up Ability to understand the purpose of the trial and act accordingly Compliance of patient Signed informed consent Lack of exclusion criteria 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 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250
Exclusion criteria
Exclusion criteria: Burkitt's lymphoma Primary cerebral lymphoma Start of therapy before attempted inclusion (except pre-phase therapy of the study protocol) Prior chemo- and/or radiotherapy Other neoplastic diseases within the preceding 5 years (except carcinoma in situ or basal cell carcinoma of the skin) Active viral hepatitis, HIV infection or other uncontrolled infections Severe organ dysfunction not explained by the lymphoma precluding administration of chemotherapy according to the study protocol Pregnancy Lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Characterisation of patients with a negative pre-treatment PET scan, determining the rate of interim PET responders after 2 cycles of (R)-CHOP in patients with a positive pre-treatment PET scan, description of treatment results and side effects in interim PET responders continuing on the (R)-CHOP protocol, description of treatment results and side effects in interim PET non-responders receiving either the (R)-CHOP or the B-ALL protocol, description of treatment results and side effects in patients with refractory or relapsed lymphomas receiving the (R)-DHAP-BEAM-(R) protocol (18 - 60 years) or the (R)-ESHAP protocol (60 - 80 year), establishment of improved guidelines for the evaluation of PET scans in patients with aggressive non-Hodgkin's lymphomas; Main Objective: Comparison of treatment results in patients with CD20-positive lymphomas and a good response to 2 cycles of the (R)-CHOP protocol as assessed by positron emission tomography (interim PET) by randomisation between a further 4 cycles of the R-CHOP protocol or 4 cycles R-CHOP plus 2 additional applications of rituximab (R) Comparison of treatment results in patients with a poor response to 2 cycles of the (R)-CHOP protocol as assessed by interim PET by randomisation between a further 6 cycles of the R-CHOP protocol or 6 blocks of the B-ALL protocol ;Primary end point(s): Time to treatment failure from randomisation;Timepoint(s) of evaluation of this end point: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Interim PET response, adverse events, quality of life, remission rate, progression-free survival, overall survival;Timepoint(s) of evaluation of this end point: After 2 treatment cycles, end of treatment, 2 years | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Ulrich Dührsen
PETAL Study Group
Outcome results
None listed