Aggressive malignant lymphoma MedDRA version: 9.1 Level: LLT Classification code 10012818 Term: Diffuse large B-cell lymphoma
Conditions
Interventions
Product Name: Doxorubicin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Doxorubicin
CAS Number: 25316-40-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
FONDAZIONE MICHELANGELO - AVANZAMENTO DELLO STUDIO E CURA DEI TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of DLBCL 2. Age 65 and older, or between 60 and 65 in the presence of contraindications to high dose myeloablative chemotherapy 3. Presence of 1 or more of the following factors high LDH levels, PS 2-4, stage III-IV, 1 extranodal involvement 4. CD20 positive lymphoma 5. DLCO 50 and ejection fraction 45 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Histology other than the one described above 2. Severe concomitant or uncontrolled nonmalignant diseases 3. Presence of opportunistic infections or HIV positivity or HBsAg positivity 4. Previous or concomitant malignancies, except non-melanoma skin tumors and in situ carcinoma of the cervix 5. History of amafilaxis or serum allergic reactions 6. Unable to out-patient follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of a High Dose Sequential HDS chemotherapy plus Zevalin vs standard R-CHOP regimen;Secondary Objective: To assess hematological and non-hematological toxicity both acute and delayed;Primary end point(s): Disease-free survival at 12 months | — |
Countries
Italy
Outcome results
None listed