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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-DHAP/R-ICE | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-DHAP/R-ICE | Drug | R-DHAP/R-ICE 3 cycles every 21 days:
Conditioning BEAM or FEAM |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 36 months |
| 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. | 100 days from the high doses |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission (CR) rate | 48 months (at the end of therapy) | |
| Overall Survival (OS) | 48 months (at the end of therapy) | |
| Adverse events incidence evaluation (grade III or IV) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luca Castagna, MD | IRCCS Humanitas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O. SS.Antonio e Biagio e C. Arrigo | Recruiting | Alessandria | AL | 15121 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40055982 | Derived | 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. |
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|
|
Number of participants with adverse events (grade III or IV) |
| 48 months (at the end of therapy) |
| 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) | 54 months |
| Immunologic evaluation | Rating basic immunology and 6 months after therapy high doses (lymphocyte subpopulations and Ig subclasses) | 54 months |
| Ospedali Riuniti | Recruiting | Ancona | AN | 60126 | Italy |
|
| Ospedale Perrino | Active, not recruiting | Brindisi | BR | 72100 | Italy |
| Spedali Civili | Recruiting | Brescia | BS | 25123 | Italy |
|
| Policlinico Vittorio Emanuele | Active, not recruiting | Catania | CT | 95123 | Italy |
| Casa Sollievo della Sofferenza | Active, not recruiting | San Giovanni Rotondo | FG | 71013 | Italy |
| IRST Meldola | Recruiting | Meldola | Forlì-Cesena | 47014 | Italy |
|
| IRCCS San Martino - IST | Active, not recruiting | Genova | GE | 16132 | Italy |
| ASUR Marche, Area Vasta 3 | Active, not recruiting | Civitanova Marche | MC | 62012 | Italy |
| AO Riuniti Papardo Piemonte | Recruiting | Messina | ME | 98158 | Italy |
|
| IRCCS Humanitas | Recruiting | Rozzano | Milano | 20089 | Italy |
|
| AO Niguarda Ca' Granda | Recruiting | Milan | MI | 20162 | Italy |
|
| Ospedale Civile "Guglielmo da Saliceto" | Recruiting | Piacenza | PC | 29100 | Italy |
|
| Centro di Riferimento Oncologico | Recruiting | Aviano | PN | 33081 | Italy |
|
| Azienda Ospaliero Universitaria di Parma | Recruiting | Parma | PR | 43126 | Italy |
|
| Ospedale San Carlo | Active, not recruiting | Potenza | PZ | 85100 | Italy |
| AUSL di Ravenna | Recruiting | Ravenna | RA | 48100 | Italy |
|
| A.O. Bianchi - Melacrino - Morelli | Active, not recruiting | Reggio Calabria | RC | 89125 | Italy |
| Asmn-Irccs | Recruiting | Reggio Emilia | RE | 43123 | Italy |
|
| Policlinico Sant'Andrea | Recruiting | Roma | RM | 00189 | Italy |
|
| Ospedale Nocera- Pagani | Active, not recruiting | Nocera Inferiore | SA | 84014 | Italy |
| AOU San Giovanni e Ruggi | Active, not recruiting | Salerno | SA | 84131 | Italy |
| AOU Città della Salute e della Scienza | Recruiting | Torino | TO | 10126 | Italy |
|
| Ospedale Mauriziano | Active, not recruiting | Torino | TO | 10128 | Italy |
| AO Santa Maria | Active, not recruiting | Terni | TR | 05100 | Italy |
| Ospedale S.Andrea | Active, not recruiting | Vercelli | VC | 13100 | Italy |
| Ospedale degli Infermi | Recruiting | Rimini | 47923 | Italy |
|
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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