Phase II of High-dose Therapy in Elderly Patients With Relapsed Aggressive NHL or Resistant to First Line Therapy
NCT ID: NCT02371161
Last Updated: 2018-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
135 participants
INTERVENTIONAL
2014-02-28
2023-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
75 Years
ALL
No
Sponsors
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Fondazione Italiana Linfomi - ETS
OTHER
Responsible Party
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Principal Investigators
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Luca Castagna, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Humanitas
Locations
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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
IRCCS Humanitas
Rozzano, Milano, Italy
AO Niguarda Ca' Granda
Milan, MI, Italy
Ospedale Civile "Guglielmo da Saliceto"
Piacenza, PC, Italy
Centro di Riferimento Oncologico
Aviano, PN, Italy
Azienda Ospaliero Universitaria di Parma
Parma, PR, Italy
Ospedale San Carlo
Potenza, PZ, Italy
AUSL di Ravenna
Ravenna, RA, Italy
A.O. Bianchi - Melacrino - Morelli
Reggio Calabria, RC, Italy
Asmn-Irccs
Reggio Emilia, RE, Italy
Policlinico Sant'Andrea
Roma, RM, Italy
Ospedale Nocera- Pagani
Nocera Inferiore, SA, Italy
AOU San Giovanni e Ruggi
Salerno, SA, Italy
AOU Città della Salute e della Scienza
Torino, TO, Italy
Ospedale Mauriziano
Torino, TO, Italy
AO Santa Maria
Terni, TR, Italy
Ospedale S.Andrea
Vercelli, VC, Italy
Ospedale degli Infermi
Rimini, , Italy
Countries
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Facility Contacts
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References
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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.
Other Identifiers
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FIL_RecAnz
Identifier Type: -
Identifier Source: org_study_id
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