Phase II prospective study on high dose myeloablative therapy, with peripheral stem cell support, in elderly patients (>=65 e <76 years) with aggressive relapsed or refractory non Hodgkin lymphoma - ND

Phase 1

• Conditions: Aggressive relapsed or refractory non Hodgkin lymphoma; MedDRA version: 9.1Level: LLTClassification code 10063908

• Registration Number: EUCTR2009-015974-36-IT
• Lead Sponsor: G.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-13
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1)Histological diagnosis of B-cell lymphoma (follicular lymphoma grade IIIb, diffuse large B-cell lymphoma, transformed indolent lymphoma, mantle cell lymphoma) or peripheral T-cell lymphoma; 2)Relapsed or refractory patient after a first line therapy with antracyclines (less than the maxim total dose of 550 mg/m2), not treated with high dose therapy and peripheral stem cell rescue; 3)Age >= 65 and > 76 years; 4)Patient not frail based on the Multidimensional geriatric evaluation; 5)Measurable disease; 6)ANC >=1500/mm3 and platelets >=100.000/106L; 7)Normal renal and hepatic function; 8)LVEF > 50%, DLCO>70% e/o PA O2>70mmHg
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

1)HBV, HCV,HIV positivity; 2)CNS involvement by lymphoma; 3)Bone marrow involvement >20%; 4)Other chemotherapy or radiotherapy treatment; 5)Significant cardiovascular pathologies; 6)Hepatic and renal disfunction related to lymphoma; 7)Active infection; 8)Frail patient

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified