search
Back to results

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

Primary Purpose

Non Hodgkin Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
R-DHAP/R-ICE
Sponsored by
Fondazione Italiana Linfomi - ETS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Hodgkin Lymphoma

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • A.O. SS.Antonio e Biagio e C. ArrigoRecruiting
  • Ospedali RiunitiRecruiting
  • Ospedale Perrino
  • Spedali CiviliRecruiting
  • Policlinico Vittorio Emanuele
  • Casa Sollievo della Sofferenza
  • IRST MeldolaRecruiting
  • IRCCS San Martino - IST
  • ASUR Marche, Area Vasta 3
  • AO Riuniti Papardo PiemonteRecruiting
  • IRCCS HumanitasRecruiting
  • AO Niguarda Ca' GrandaRecruiting
  • Ospedale Civile "Guglielmo da Saliceto"Recruiting
  • Centro di Riferimento OncologicoRecruiting
  • Azienda Ospaliero Universitaria di ParmaRecruiting
  • Ospedale San Carlo
  • AUSL di RavennaRecruiting
  • A.O. Bianchi - Melacrino - Morelli
  • Asmn-IrccsRecruiting
  • Policlinico Sant'AndreaRecruiting
  • Ospedale Nocera- Pagani
  • AOU San Giovanni e Ruggi
  • AOU Città della Salute e della ScienzaRecruiting
  • Ospedale Mauriziano
  • AO Santa Maria
  • Ospedale S.Andrea
  • Ospedale degli InfermiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

R-DHAP/R-ICE

Arm 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

Outcomes

Primary Outcome Measures

Event free survival EFS
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
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

Complete Remission (CR) rate
Overall Survival (OS)
Adverse events incidence evaluation (grade III or IV)
Number of participants with adverse events (grade III or IV)
Quality of Life (QoL)
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)
Immunologic evaluation
Rating basic immunology and 6 months after therapy high doses (lymphocyte subpopulations and Ig subclasses)

Full Information

First Posted
February 11, 2015
Last Updated
April 24, 2018
Sponsor
Fondazione Italiana Linfomi - ETS
search

1. Study Identification

Unique Protocol Identification Number
NCT02371161
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Italiana Linfomi - ETS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
R-DHAP/R-ICE
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
R-DHAP/R-ICE
Other Intervention Name(s)
R-DHAP or R-ICE and BEAM or FEAM
Intervention Description
R-DHAP/R-ICE 3 cycles every 21 days: 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) 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
Primary Outcome Measure Information:
Title
Event free survival EFS
Description
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.
Time Frame
36 months
Title
Treatment related mortality TRM
Description
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.
Time Frame
100 days from the high doses
Secondary Outcome Measure Information:
Title
Complete Remission (CR) rate
Time Frame
48 months (at the end of therapy)
Title
Overall Survival (OS)
Time Frame
48 months (at the end of therapy)
Title
Adverse events incidence evaluation (grade III or IV)
Description
Number of participants with adverse events (grade III or IV)
Time Frame
48 months (at the end of therapy)
Title
Quality of Life (QoL)
Description
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)
Time Frame
54 months
Title
Immunologic evaluation
Description
Rating basic immunology and 6 months after therapy high doses (lymphocyte subpopulations and Ig subclasses)
Time Frame
54 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Castagna, MD
Organizational Affiliation
IRCCS Humanitas
Official's Role
Principal Investigator
Facility Information:
Facility Name
A.O. SS.Antonio e Biagio e C. Arrigo
City
Alessandria
State/Province
AL
ZIP/Postal Code
15121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavia Salvi, MD
Phone
0131-206066
Email
fsalvi@ospedale.al.it
First Name & Middle Initial & Last Name & Degree
Flavia Salvi, MD
Facility Name
Ospedali Riuniti
City
Ancona
State/Province
AN
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Attilio Olivieri, MD
Phone
071-5964226
Email
a.olivieri@univpm.it
First Name & Middle Initial & Last Name & Degree
Attilio Olivieri, MD
Facility Name
Ospedale Perrino
City
Brindisi
State/Province
BR
ZIP/Postal Code
72100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Spedali Civili
City
Brescia
State/Province
BS
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Tucci, MD
Phone
030-3995438
Email
alessandra.tucci@spedalicivili.brescia.it
First Name & Middle Initial & Last Name & Degree
Alessandra Tucci, MD
Facility Name
Policlinico Vittorio Emanuele
City
Catania
State/Province
CT
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
State/Province
FG
ZIP/Postal Code
71013
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
IRST Meldola
City
Meldola
State/Province
Forlì-Cesena
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerardo Musuraca
Phone
0543-739291
Email
g.musuraca@irst.emr.it
First Name & Middle Initial & Last Name & Degree
Gerardo Musuraca, MD
Facility Name
IRCCS San Martino - IST
City
Genova
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
ASUR Marche, Area Vasta 3
City
Civitanova Marche
State/Province
MC
ZIP/Postal Code
62012
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
AO Riuniti Papardo Piemonte
City
Messina
State/Province
ME
ZIP/Postal Code
98158
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donato Mannina, MD
Phone
090-3992239
Email
donamanni@gmail.com
First Name & Middle Initial & Last Name & Degree
Donato Mannina, MD
Facility Name
IRCCS Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Castagna, MD
Phone
02-82244580
Email
luca.castagna@humanitas.it
First Name & Middle Initial & Last Name & Degree
Luca Castagna, MD
Facility Name
AO Niguarda Ca' Granda
City
Milano
State/Province
MI
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiara Rusconi, MD
Phone
02-64442668
Email
chiara.rusconi@ospedaleniguarda.it
First Name & Middle Initial & Last Name & Degree
Chiara Rusconi, MD
Facility Name
Ospedale Civile "Guglielmo da Saliceto"
City
Piacenza
State/Province
PC
ZIP/Postal Code
29100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniele Vallisa, MD
Phone
0523-303719
Email
d.vallisa@ausl.pc.it
First Name & Middle Initial & Last Name & Degree
Danilele Vallisa, MD
Facility Name
Centro di Riferimento Oncologico
City
Aviano
State/Province
PN
ZIP/Postal Code
33081
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariagrazia Michieli, MD
Phone
0434-659601
Email
mmichieli@cro.it
First Name & Middle Initial & Last Name & Degree
Mariagrazia Michieli, MD
Facility Name
Azienda Ospaliero Universitaria di Parma
City
Parma
State/Province
PR
ZIP/Postal Code
43126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Re, MD
Phone
0521-033306
Email
fre@ao.pr.it
First Name & Middle Initial & Last Name & Degree
Francesca Re, Prof.
Facility Name
Ospedale San Carlo
City
Potenza
State/Province
PZ
ZIP/Postal Code
85100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
AUSL di Ravenna
City
Ravenna
State/Province
RA
ZIP/Postal Code
48100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Tani, MD
Phone
0544-286223
Email
monica.tani@ausl.ra.it
First Name & Middle Initial & Last Name & Degree
Monica Tani, MD
Facility Name
A.O. Bianchi - Melacrino - Morelli
City
Reggio Calabria
State/Province
RC
ZIP/Postal Code
89125
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Asmn-Irccs
City
Reggio Emilia
State/Province
RE
ZIP/Postal Code
43123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Merli, MD
Phone
0522-296618
Email
merli.francesco@asmn.re.it
First Name & Middle Initial & Last Name & Degree
Francesco Merli, MD
Facility Name
Policlinico Sant'Andrea
City
Roma
State/Province
RM
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Christina Cox, MD
Phone
338-2268017
Email
chrisscox@gmail.com
First Name & Middle Initial & Last Name & Degree
Maria Christina Cox, MD
Facility Name
Ospedale Nocera- Pagani
City
Nocera Inferiore
State/Province
SA
ZIP/Postal Code
84014
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
AOU San Giovanni e Ruggi
City
Salerno
State/Province
SA
ZIP/Postal Code
84131
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
AOU Città della Salute e della Scienza
City
Torino
State/Province
TO
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Federica Cavallo, MD
Phone
011-6334301
Email
f.cavallo@unito.it
First Name & Middle Initial & Last Name & Degree
Federica Cavallo, MD
Facility Name
Ospedale Mauriziano
City
Torino
State/Province
TO
ZIP/Postal Code
10128
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
AO Santa Maria
City
Terni
State/Province
TR
ZIP/Postal Code
05100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale S.Andrea
City
Vercelli
State/Province
VC
ZIP/Postal Code
13100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale degli Infermi
City
Rimini
ZIP/Postal Code
47923
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Lia Molinari
Phone
0541-705423
Email
annalia.molinari@auslromagna.it
First Name & Middle Initial & Last Name & Degree
Anna Lia Molinari, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs