NCT02371161

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

A Phase II Prospective Study of High-dose Myeloablative Therapy, With Stem Cell Devices Support in Elderly Patients (≥65 and ≤ 75 Years) With Relapsed Aggressive Non-Hodgkin Lymphoma or Resistant to First Line Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 65 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Non Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	R-DHAP/R-ICE	R-DHAP/R-ICE 3 cycles every 21 days: 1. R-DHAP * Rituximab 375 mg/m2, e.v. day 1 * Desamethasone 40 mg days 1-4 * cis-Platino100 mg/m2, day 2 (if ≥70 years 75 mg/m2) * Aracytin 2000 mg/m2, e.v. day 3 (if ≥70 years 1500 mg/m2) 2. R-ICE * Rituximab 375 mg/m2, e.v. day 1 * Etoposide 100 mg/mq, e.v. days 1,2,3 (if ≥70 years 75 mg/mq) * Ifosfamide with Mesna equidone 5000 mg/mq, day 2 (if ≥70 years 3750 mg/mq) * Carboplatino AUC=5, e.v. (max 800 mg/mq), day 2 (if ≥70 years AUC=4) Conditioning BEAM or FEAM

Timeline

• Start date: 2014-02-01
• Primary completion: 2018-12-01
• Completion: 2023-02-01
• First posted: 2015-02-25
• Last updated: 2018-04-25

Locations

27 sites across 1 country: Italy