Phase II of High-dose Therapy in Elderly Patients With Relapsed Aggressive NHL or Resistant to First Line Therapy
- Conditions
- Non Hodgkin Lymphoma
- Interventions
- Drug: R-DHAP/R-ICE
- Registration Number
- NCT02371161
- Lead Sponsor
- Fondazione Italiana Linfomi - ETS
- Brief 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)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 135
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description R-DHAP/R-ICE R-DHAP/R-ICE 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
- Primary Outcome Measures
Name Time Method Event free survival EFS 36 months Evaluate the toxicity and activity of a therapeutic approach to high doses with stem cell support device (PBSC) in patients aged ≥ 65 and ≤75 years, chemosensitive relapsed or refractory to 1st line therapy in terms of EFS.
Treatment related mortality TRM 100 days from the high doses Evaluate the toxicity and activity of a therapeutic approach to high doses with stem cell support device (PBSC) in patients aged ≥ 65 and ≤75 years, chemosensitive relapsed or refractory to 1st line therapy in terms of TRM.
- Secondary Outcome Measures
Name Time Method Complete Remission (CR) rate 48 months (at the end of therapy) Overall Survival (OS) 48 months (at the end of therapy) Immunologic evaluation 54 months Rating basic immunology and 6 months after therapy high doses (lymphocyte subpopulations and Ig subclasses)
Adverse events incidence evaluation (grade III or IV) 48 months (at the end of therapy) Number of participants with adverse events (grade III or IV)
Quality of Life (QoL) 54 months Evaluate the quality of life (QoL) before, after therapy rescue and after six months of high-dose therapy through the quality of life questionnaire of European Organization for Research and Treatment of Cancer (EORTC QLQ-C30)
Trial Locations
- Locations (27)
A.O. SS.Antonio e Biagio e C. Arrigo
🇮🇹Alessandria, AL, Italy
Ospedali Riuniti
🇮🇹Ancona, AN, Italy
Ospedale Perrino
🇮🇹Brindisi, BR, Italy
Spedali Civili
🇮🇹Brescia, BS, Italy
Policlinico Vittorio Emanuele
🇮🇹Catania, CT, Italy
Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, FG, Italy
IRST Meldola
🇮🇹Meldola, Forlì-Cesena, Italy
IRCCS San Martino - IST
🇮🇹Genova, GE, Italy
ASUR Marche, Area Vasta 3
🇮🇹Civitanova Marche, MC, Italy
AO Riuniti Papardo Piemonte
🇮🇹Messina, ME, Italy
Scroll for more (17 remaining)A.O. SS.Antonio e Biagio e C. Arrigo🇮🇹Alessandria, AL, ItalyFlavia Salvi, MDPrincipal Investigator