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Non Hodgkin LymphomaPhase 2NCT02371161

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

A Phase 2 study testing R-DHAP/R-ICE in people with Non Hodgkin Lymphoma, run by Fondazione Italiana Linfomi - ETS at 27 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 75 years
Conditions the study is for
Non Hodgkin Lymphoma
What is being tested?
R-DHAP/R-ICE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
27 sitesItaly
Study dates
Feb 2014to Feb 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 75 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • HBV+ - HCV+ - HIV+
  • NSC involvement - medullar infiltration > 20%
  • other chemotherapy or radiotherapy
  • cardiac disease
  • alteration of liver and kidney function
  • infections
Show all 9Show fewer
  • demented patient
  • no compliance and depressed pts
  • Frail and Unfit pts

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Italy27 sites, 15 recruiting

  • A.O. SS.Antonio e Biagio e C. Arrigo

    Alessandria, AL, 15121

    Flavia Salvi, MD, 0131-206066, fsalvi@ospedale.al.it

    Flavia Salvi, MD

    Recruiting

  • Ospedali Riuniti

    Ancona, AN, 60126

    Attilio Olivieri, MD, 071-5964226, a.olivieri@univpm.it

    Attilio Olivieri, MD

    Recruiting

  • Centro di Riferimento Oncologico

    Aviano, PN, 33081

    Mariagrazia Michieli, MD, 0434-659601, mmichieli@cro.it

    Mariagrazia Michieli, MD

    Recruiting

  • Spedali Civili

    Brescia, BS, 25123

    Alessandra Tucci, MD, 030-3995438, alessandra.tucci@spedalicivili.brescia.it

    Alessandra Tucci, MD

    Recruiting

  • Ospedale Perrino

    Brindisi, BR, 72100

    Active, not recruiting

  • Policlinico Vittorio Emanuele

    Catania, CT, 95123

    Active, not recruiting

  • ASUR Marche, Area Vasta 3

    Civitanova Marche, MC, 62012

    Active, not recruiting

  • IRCCS San Martino - IST

    Genova, GE, 16132

    Active, not recruiting

  • IRST Meldola

    Meldola, Forlì-Cesena, 47014

    Gerardo Musuraca, 0543-739291, g.musuraca@irst.emr.it

    Gerardo Musuraca, MD

    Recruiting

  • AO Riuniti Papardo Piemonte

    Messina, ME, 98158

    Donato Mannina, MD, 090-3992239, donamanni@gmail.com

    Donato Mannina, MD

    Recruiting

  • AO Niguarda Ca' Granda

    Milan, MI, 20162

    Chiara Rusconi, MD, 02-64442668, chiara.rusconi@ospedaleniguarda.it

    Chiara Rusconi, MD

    Recruiting

  • Ospedale Nocera- Pagani

    Nocera Inferiore, SA, 84014

    Active, not recruiting

  • Azienda Ospaliero Universitaria di Parma

    Parma, PR, 43126

    Francesca Re, MD, 0521-033306, fre@ao.pr.it

    Francesca Re, Prof.

    Recruiting

  • Ospedale Civile "Guglielmo da Saliceto"

    Piacenza, PC, 29100

    Daniele Vallisa, MD, 0523-303719, d.vallisa@ausl.pc.it

    Danilele Vallisa, MD

    Recruiting

  • Ospedale San Carlo

    Potenza, PZ, 85100

    Active, not recruiting

  • AUSL di Ravenna

    Ravenna, RA, 48100

    Monica Tani, MD, 0544-286223, monica.tani@ausl.ra.it

    Monica Tani, MD

    Recruiting

  • A.O. Bianchi - Melacrino - Morelli

    Reggio Calabria, RC, 89125

    Active, not recruiting

  • Asmn-Irccs

    Reggio Emilia, RE, 43123

    Francesco Merli, MD, 0522-296618, merli.francesco@asmn.re.it

    Francesco Merli, MD

    Recruiting

  • Ospedale degli Infermi

    Rimini, 47923

    Anna Lia Molinari, 0541-705423, annalia.molinari@auslromagna.it

    Anna Lia Molinari, MD

    Recruiting

  • Policlinico Sant'Andrea

    Roma, RM, 00189

    Maria Christina Cox, MD, 338-2268017, chrisscox@gmail.com

    Maria Christina Cox, MD

    Recruiting

  • IRCCS Humanitas

    Rozzano, Milano, 20089

    Luca Castagna, MD, 02-82244580, luca.castagna@humanitas.it

    Luca Castagna, MD

    Recruiting

  • AOU San Giovanni e Ruggi

    Salerno, SA, 84131

    Active, not recruiting

  • Casa Sollievo della Sofferenza

    San Giovanni Rotondo, FG, 71013

    Active, not recruiting

  • AO Santa Maria

    Terni, TR, 05100

    Active, not recruiting

  • AOU Città della Salute e della Scienza

    Torino, TO, 10126

    Federica Cavallo, MD, 011-6334301, f.cavallo@unito.it

    Federica Cavallo, MD

    Recruiting

  • Ospedale Mauriziano

    Torino, TO, 10128

    Active, not recruiting

  • Ospedale S.Andrea

    Vercelli, VC, 13100

    Active, not recruiting

Other trials in Italy

About this study

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

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.

Read the 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)

Being tested
R-DHAP/R-ICE
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • R-DHAP/R-ICEDrug

    Also called R-DHAP or R-ICE and BEAM or FEAM

    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)
    1. 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

Study groups in NCT02371161
Study groupRoleWhat they receive
R-DHAP/R-ICEExperimentalHigh-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
Receives: Drug: R-DHAP/R-ICE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 36 months

  2. 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.

    Measured: 100 days from the high doses

Secondary outcomes (5)

  1. Complete Remission (CR) rate

    Measured: 48 months (at the end of therapy)

  2. Overall Survival (OS)

    Measured: 48 months (at the end of therapy)

  3. Adverse events incidence evaluation (grade III or IV)

    Number of participants with adverse events (grade III or IV)

    Measured: 48 months (at the end of therapy)

  4. 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)

    Measured: 54 months

  5. Immunologic evaluation

    Rating basic immunology and 6 months after therapy high doses (lymphocyte subpopulations and Ig subclasses)

    Measured: 54 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2015 (estimated)
  2. Study startFeb 2014
  3. Primary completionDec 2018 (estimated)
  4. Study completionFeb 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02371161
Sponsor's protocol ID
FIL_RecAnz
Status last verified
Apr 2018
First submitted
11 Feb 2015
Last updated
25 Apr 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Publications

  • Tucci A, Re A, Pagani C, Marcheselli L, Marcheselli R, Malaspina F, Cavallo F, Zilioli VR, Zanni M, Mannina D, Michieli M, Arcari A, Castagna L, Musuraca G, Clerico M, Merli F, Tani M, Re F, Gini G, Rotondo F, Turrini M, Rossi G, Cox MC. A phase 2 study of autologous stem cell transplantation as salvage therapy for older patients with aggressive B-cell lymphoma prospectively evaluated by comprehensive geriatric assessment: the FIL_RECANZ study. Leuk Lymphoma. 2025 Jul;66(7):1284-1292. doi: 10.1080/10428194.2025.2471499. Epub 2025 Mar 8.

    PubMed 40055982

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing R-DHAP/R-ICE in people with Non Hodgkin Lymphoma, run by Fondazione Italiana Linfomi - ETS at 27 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event free survival EFS (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02371161, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018.

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