se of mieloablative doses of zevalin in aggressive lymphomas of the elderly. Prospective randomized study Z-HDS1,2 vs R-CHOP - Z-HDS1,2 vs R-CHOP protocol
- Conditions
- Aggressive malignant lymphomaMedDRA version: 9.1Level: LLTClassification code 10012818Term: Diffuse large B-cell lymphoma
- Registration Number
- EUCTR2006-002524-42-IT
- Lead Sponsor
- FONDAZIONE MICHELANGELO - AVANZAMENTO DELLO STUDIO E CURA DEI TUMORI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method