Clinical trial NCT02371161: Phase II of High-dose Therapy in Elderly Patients With Relapsed Aggressive NHL or Resistant to First Line Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non Hodgkin Lymphoma
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
First posted: 2015-02-25
Enrollment: 135
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility 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

Primary outcomes:
measure: Event free survival EFS
timeFrame: 36 months
measure: Treatment related mortality TRM
timeFrame: 100 days from the high doses
Secondary outcomes:
measure: Complete Remission (CR) rate
timeFrame: 48 months (at the end of therapy)
measure: Overall Survival (OS)
timeFrame: 48 months (at the end of therapy)
measure: Adverse events incidence evaluation (grade III or IV)
timeFrame: 48 months (at the end of therapy)
measure: Quality of Life (QoL)
timeFrame: 54 months
measure: Immunologic evaluation
timeFrame: 54 months
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: A.O. SS.Antonio e Biagio e C. Arrigo
state: AL
city: Ancona
country: Italy
facility: Ospedali Riuniti
state: AN
city: Brindisi
country: Italy
facility: Ospedale Perrino
state: BR
city: Brescia
country: Italy
facility: Spedali Civili
state: BS
city: Catania
country: Italy
facility: Policlinico Vittorio Emanuele
state: CT
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo della Sofferenza
state: FG
city: Meldola
country: Italy
facility: IRST Meldola
state: Forlì-Cesena
city: Genova
country: Italy
facility: IRCCS San Martino - IST
state: GE
city: Civitanova Marche
country: Italy
facility: ASUR Marche, Area Vasta 3
state: MC
city: Messina
country: Italy
facility: AO Riuniti Papardo Piemonte
state: ME
city: Rozzano
country: Italy
facility: IRCCS Humanitas
state: Milano
city: Milano
country: Italy
facility: AO Niguarda Ca' Granda
state: MI
city: Piacenza
country: Italy
facility: Ospedale Civile "Guglielmo da Saliceto"
state: PC
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico
state: PN
city: Parma
country: Italy
facility: Azienda Ospaliero Universitaria di Parma
state: PR
city: Potenza
country: Italy
facility: Ospedale San Carlo
state: PZ
city: Ravenna
country: Italy
facility: AUSL di Ravenna
state: RA
city: Reggio Calabria
country: Italy
facility: A.O. Bianchi - Melacrino - Morelli
state: RC
city: Reggio Emilia
country: Italy
facility: Asmn-Irccs
state: RE
city: Roma
country: Italy
facility: Policlinico Sant'Andrea
state: RM
city: Nocera Inferiore
country: Italy
facility: Ospedale Nocera- Pagani
state: SA
city: Salerno
country: Italy
facility: AOU San Giovanni e Ruggi
state: SA
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza
state: TO
city: Torino
country: Italy
facility: Ospedale Mauriziano
state: TO
city: Terni
country: Italy
facility: AO Santa Maria
state: TR
city: Vercelli
country: Italy
facility: Ospedale S.Andrea
state: VC
city: Rimini
country: Italy
facility: Ospedale degli Infermi
Study officials:
affiliation: IRCCS Humanitas
name: Luca Castagna, MD
role: PRINCIPAL_INVESTIGATOR
References: