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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 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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-015974-36-IT
Enrollment
Unknown
Registered
2009-10-13
Start date
2009-09-28
Completion date
Unknown
Last updated
2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aggressive relapsed or refractory non Hodgkin lymphoma MedDRA version: 9.1 Level: LLT Classification code 10063908

Interventions

Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Dexamethasone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 8- Pharmaceutical For

Sponsors

G.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: To assess the efficacy and tolerability of high dose therapy plus PBSC transplant in terms of EFS and treatment related mortality;Secondary Objective: To evaluate: -the length of telomeres and the telomerases activity on MNC before high dose therapy, on PBSC and on MNC three month after transplant; - the absolute lymphocytes count before apheresis and 15 days after PBSC reinfusion; - the immunologic recovery at three months; - the incidence of severe adverse events (grade III and IV); - the number of complete remissions; - the overall survival.;Primary end point(s): 1) 1 year event free survival. 2)Treatment related mortality (evaluated 100 days after high dose therapy).—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026