Phase II of High-dose Therapy in Elderly Patients With Relapsed Aggressive NHL or Resistant to First Line Therapy

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

A phase II prospective, non-randomized study. The study aim is to evaluate the feasibility and activity of high-dose therapy with stem cell in elderly patients with aggressive lymphoma relapsed FIT or resistant to first line therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Italiana Linfomi ONLUS

Criteria

Inclusion Criteria:

• Diagnosis of NHL

• relapse and refractory pts

• age ≥ 65 and ≤75

• ECOG performance status <2

• FIT patients (Instrumental Activity of Daily Living (IADL)=8, Activity of Daily Living (ADL)=6, Cumulative Illness Rating Scale (CIRS) =0 SCORE=3-4, <5 SCORE=2 )

• evaluable disease

• no RT since 3 week

• absolute neutrophil count >= 1500/mm3 and platelets >= 100.000/106L

• Creatinin <= 1.5 mg/dL and clearance >40 ml/min/24 h

• bilirubins < =2 mg/dL

• forced expiratory volume >50% - arterial pressure O2 >70 mmHg

• no other neoplastic disease

• Life expectancy> 3 months

• signed informed consent

Exclusion Criteria:

• HBV+ - HCV+ - HIV+

• NSC involvement - medullar infiltration > 20%

• other chemotherapy or radiotherapy

• cardiac disease

• alteration of liver and kidney function

• infections

• demented patient

• no compliance and depressed pts

• Frail and Unfit pts