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

Fondazione Italiana Linfomi - ETS

Status and phase: Unknown; Phase 2

Conditions: Non Hodgkin Lymphoma

Treatments: Drug: R-DHAP/R-ICE

Study type: Interventional

Funder types: Other

Identifiers

NCT02371161

FIL_RecAnz

Details and patient eligibility

About

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.

Full description

The study aim is to evaluate the toxicity and activity of a therapeutic approach to high doses with support of peripheral blood stem cells (PBSC) in patients aged ≥ 65 and ≤75 years, chemosensitive relapsed or refractory to therapy first line in terms of event free survival (EFS) and treatment related mortality (TRM)

Enrollment: 135 estimated patients

Sex: All

Ages: 65 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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135 participants in 1 patient group

R-DHAP/R-ICE

Experimental group

Description:

High-dose myeloablative therapy (R-DHAP or R-ICE) and conditioning therapy (BEAM or FEAM) in elderly patients with relapsed NHL or resistant to firs line therapy

Treatment:

Drug: R-DHAP/R-ICE