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Failure of accrual achievement
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| Name | Class |
|---|---|
| Istituto Clinico Humanitas | OTHER |
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PET-based consolidation and donor-based therapy after rescue in patients with Hodgkin's lymphoma refractory at first line therapy, or relapse early or late, undergone a second line chemotherapy.
This is a prospective observational study in which patients with positive PET scan after salvage therapy are candidates to a sequential scheme "auto-allotransplantation" in case of availability of a donor . In the event of unavailability of a donor , the same patients are candidates for a double high-dose chemotherapy with autologous stem cell support.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients with negative PET after salvage therapy | Other | All patients included in the study will treat with a salvage scheme according to each center. After the end of salvage therapy, consolidation depends on the outcome of PET: PET negative: These patients will follow a standard treatment that includes high-dose chemotherapy with reinfusion of autologous peripheral stem cells. | ||
| Patients with positive PET after salvage therapy | Other | All patients included in the study will treat with a salvage scheme according to each center. After the end of salvage therapy, consolidation depends on the outcome of PET PET positive, the consolidation therapy consists of 2 phases:
If there is not a donor, the patient will continue with a second round of high-dose chemotherapy with BEAM with reinfusion of autologous peripheral stem cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Patients with negative PET after salvage therapy. To assess prospectively the overall survival and progression-free | 3 years | |
| Patients with positive PET after salvage therapy. Evaluate the role of allogeneic transplantation in these patients after salvage chemotherapy and compare the results with those obtained by 2 cycles of high dose chemotherapy with stem cell | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the percentage of complete remission. | 3 years | |
| Evaluate the haematological toxicity and non-haematological (including acute and chronic GVHD, infections). | 3 years | |
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Inclusion Criteria:
Exclusion Criteria:
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Patients confirmed Hodgkin's lymphoma at refractory at first line therapy or relapse
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| Name | Affiliation | Role |
|---|---|---|
| Luca Castagna, MD | Istituto Clinico Humanitas, Dipartimento di Oncologia e Ematologia | Study Director |
| Armando Santoro, MD | Istituto Clinico Humanitas, Dipartimento di Oncologia e Ematologia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto di Ematologia e Oncologia Medica, Policlinico S. Orsola | Bologna | Bologna | 40138 | Italy | ||
| Unità funzionale di Ematologia AOU Careggi |
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| Evaluation of the chimera. |
| 3 years |
| Florence |
| Firenze |
| 50139 |
| Italy |
| Dipartimento di Oncologia Medica ed Ematologia Istituto Clinico Humanitas | Rozzano | Milano | Italy |
| Ematologia Policlinico San Matteo | Pavia | Pavia | 27100 | Italy |
| Ematologia Ospedale S. Maria delle Croci | Ravenna | RA | 48100 | Italy |
| Div Ematologia A.O. Bianchi - Melacrino - Morelli | Reggio Calabria | RC | 89125 | Italy |
| Ematologia Fondazione del Piemonte per l'Oncologia - IRCCS | Candiolo | Torino | 10060 | Italy |
| S.C. Oncologia Medica III Osp. di Circolo | Busto Arsizio | Varese | 21052 | Italy |
| UO di Oncologia Medica e Oncoematologia ASL 14 VCO di Verbania | Verbania | Verbania | 28900 | Italy |
| SC Ematologia - A.O.SS. Biagio, Antonio e Cesare Arrigo | Alessandria | Italy |
| SC Enatologia e Trapianto emopoietico AORN San G.Moscati | Avellino | Italy |
| Centro di Riferimento Oncologico - Oncologia Medica A | Aviano (PN) | Italy |
| Azienda Ospedaliera Policlinico di Bari | Bari | Italy |
| Ematologia Spedali Civili | Brescia | Italy |
| Presidio Ospedaliero A.Perrino - Divisione di Ematologia | Brindisi | Italy |
| Ematologia Ospedale A.Businco | Cagliari | Italy |
| SC Ematologia ASO S. Croce e Carle | Cuneo | 12100 | Italy |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) | Meldola (FC) | Italy |
| SC Ematologia Azienda Ospedaliera Papardo Nesima | Messina | Italy |
| Ematologia Ospedale Niguarda Cà Granda | Milan | Italy |
| Unità Linfomi - Dipartimento Oncoematologia Istituto Scientifico S. Raffaele | Milan | Italy |
| Centro Oncologico Modenese | Modena | Italy |
| AOU Federico II di Napoli | Naples | Italy |
| SCDU Ematologia AOU Maggiore della Carità | Novara | Italy |
| ASL 3 Nuoro, UOC Ematologia e CTMO HSF | Nuoro | 08100 | Italy |
| UO Ematologia Ospedale Civile G.da Saliceto | Piacenza | Italy |
| Ospedale degli Infermi - Ematologia | Rimini | Italy |
| Istituto Regina Elena IFO | Roma | Italy |
| Univeristà La Sapienza | Roma | Italy |
| Università Cattolica Policlinico Gemelli - Cattedra di Ematologia | Roma | Italy |
| UOC Ematologia Ospedale S.Eugenio | Roma | Italy |
| Casa sollievo della Sofferenza | San Giovanni Rotondo | Italy |
| UOC Ematologia e Trapianti AO Universitaria senese | Siena | Italy |
| SC Oncoematologia Azienda Ospedaliera S. Maria di Terni | Terni | Italy |
| SC Ematologia Ospedale San Giovanni Battista - Molinette | Torino | Italy |
| ASL BAT 1 Divisione di Ematologia | Trani | Italy |
| A.O.Cardinale Panico Ematologia e centro trapianti | Tricase (LE) | Italy |
| Clinica Ematologica ASUI Integrata di Udine | Udine | Italy |
| Oncologia Medica Ospedale di Circolo e Fondazione Macchi | Varese | 21100 | Italy |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| 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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