Diffuse large B-cell lymphoma MedDRA version: 21.0 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Methotrexate Hospira 100 mg/ml inj sol
Product Name: Methotrexate Hospira 100 mg/ml inj sol
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Methotrexate
CAS Numbe
Sponsors
Kooperativní lymfomová skupina, o.s.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1/histologically confirmed untreated DLBCL 2/age 18-72 years 3/signed informed consent with the study 4/planned first-line treatment 6 cycles of R CHOP +2x R or 6 cycles of DA EPOCH R+ 2xR 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 160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1/ patients with DLBCL and concomitant initial CNS involvement 2/ patients with PMBL 3/ DLBCL patients with planned another chemotherapy than R CHOP or DA EPOCH R 4/ HIV positive, or active hepatitis B or C 5/ other serious disease (based on the decision of the physician-investigator) 6/ non-compliance of a patient 7/ every containdication for administration of antracyclin regimen or high dose methotrexat 8/ pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of cumulative incidence of CNS relapses in patients treated with 2 doses of intravenous methotrexate 3g/m2 (arm A) or 6 doses of intrathecal methotrexate 12mg (arm B). ;Secondary Objective: - Evaluation and comparison of overall, survival (OS) in patients treated with 2 doses of intravenous methotrexate, 6 doses of intrathecal methotrexate and in patients without CNS prophylaxis. - Evaluation of overall response rate (ORR),complete remission rate (CRR) in all three arms of the study (A, B, C), analysis of treatment toxicity. - Evaluation of progression-free survival (PFS) in CNS and outside of CNS in all risk groups (low, intermediate and high risk). - Evaluation of definition of occult meningeal involvement: cumulative incidence of CNS relapses in subgroups with occult meningeal involvement. ;Primary end point(s): Comparison of cumulative incidence of CNS relapses in patients treated either with methotrexate 3g/m2 i.v. or 6 doses of intrathecal methotrexate 12mg.;Timepoint(s) of evaluation of this end point: 1 year after end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Complete remissions and partial remissions – will be evaluated according to PET/CT-Cheson criteria (49). Overall survival (OS) is defined as period between the date from diagnosis until date of death due to any reason. 2. Evaluation of definition of occult meningeal involvement: cumulative incidence of CNS relapses in subgroups with occult meningeal involvement: a/occult FCM positivity and concomitant CSF cytology negative; b/FCM negative and concomitant occult positivity of CSF cytology; 3. Validtion of clinical predictive risk model ;Timepoint(s) of evaluation of this end point: 1 year after end of treatment | — |
Countries
Czech Republic
Contacts
Public ContactVšeobecná fakultní nemocnice
Czech Lymphoma Study Group
Outcome results
None listed