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Peripheral T cell lymphomas (PTCL) are a rare hematologic disease. Five-year overall survival (OS) of PTCL patients (pts) ranges between 20 and 30%. Allogeneic stem cell transplantation (allo-STC) may have a curative role for these pts but its toxicity is high when myeloablative conditioning is used. Reduced intensity conditionings (RIC) can decrease transplant related toxicity and mortality. The investigators have recently proved feasibility and potential efficacy of a RIC regimen in relapsed PTCL patients.
We want to investigate whether it is possible to improve the outcome of alk negative PTCL pts, stage II-IV at diagnosis, by intensifying the therapeutic approach.
The intensification will be obtained by combining intensive chemotherapy, alemtuzumab (anti-CD52 humanised antibody) and auto- or allo-SCT in pts aged between 18 and 60 years (Clinical Study A) or adding alemtuzumab to standard chemotherapy (CHOP) in pts aged between 61 and 70 years(Clinical Study B).
Inclusion criteria Clin A
Inclusion criteria Clin B
In clinical study A (Clin A) we are planning to evaluate the efficacy and the feasibility of an intensified chemo-immunotherapy program including auto-SCT or RIC allo-SCT in advanced stage PTCL pts ≥ 18 and < or = 60 years.
In clinical study B (Clin B) we intend to verify the efficacy and the feasibility of a combined immuno-chemotherapy approach in a subset of elderly pts aged > 60 and < or = 75 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clin A | Experimental | Clin A. CHOP-Campath (CHOP-C) for 2 cycles , Hyper-C-Hidam for 2 cycles and auto-SCT (stem cell transplantation) or RIC allo-SCT in advanced stage PTCL pts ≥ 18 and ≤ 60 years |
|
| Clin B | Experimental | Clin B: CHOP-Campath (CHOP-C) for 6 cycles . It is a combined immunochemotherapy approach in a subset of elderly pts aged > 60 ≤ 75 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT | Procedure | Clin A:
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | number of clinical responses | one year |
| Measure | Description | Time Frame |
|---|---|---|
| evaluation of OS (overall survival) | OS time is calculated from patients enrollment to death for all causes; censored cases are pts alive at the date of last follow-up assessment. | 4 years |
| DFS (Disease Free Survival) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| paolo corradini | fondazione IRCCS istituto nazionale tumori Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spedali Civili di Brescia | Brescia | Brescia | 25123 | Italy | ||
| Azienda Ospedale Vittorio Emanuele Ferrarorro S. Bambino- Università di Catania |
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|
|
| Clin B (CHOP- CAMPATH) Chemo-immunotherapy | Drug | Clin B:
|
|
|
DFS time is the interval between CR achievement and the first disease relapse or death regardless of the cause.Definition of disease response/progression will be performed according to the criteria published by Juweid et al.(J Clin Oncol. 2005; 23: 4652-61)
| 4 years |
| TRM (Treatment Related Mortality) | TRM will be analysed by computing the corresponding crude cumulative incidence curve, considering disease-related death as competing event. | 4 years |
| Catania |
| Catania |
| 94124 |
| Italy |
| Ospedale San Carlo | Potenza | Potenza | 85100 | Italy |
| Azienda Ospedaliera S. Luigi | Orbassano | Torino | 10043 | Italy |
| Azienda OspedalieraSan Giovanni Battista | Torino | Torino | 10126 | Italy |
| Università di Torino- Azienda Ospedaliera S. Giovanni Battista | Torino | Torino | 10126 | Italy |
| Policlinico Universitario Udine | Udine | Udine | Italy |
| Ospedale SS. Antonio e Biagio e Cesare Arrigo | Alessandria | 15100 | Italy |
| University of Ancona - Division of Hematology | Ancona | 62020 | Italy |
| Ospedale Riuniti, Bergamo - Division of Hematology | Bergamo | 24128 | Italy |
| Ospedale Generale Regionale Bolzano | Bolzano | 39100 | Italy |
| Ospedale S. Croce - Division of Hematology | Cuneo | 12100 | Italy |
| Ospedale San Raffaele, Milano - Division of Hematology | Milan | 20100 | Italy |
| Division of Hematology - Fondazione IRCCS Istituto Nazionale Tumori | Milan | 20133 | Italy |
| IRCCS Ospedale Maggiore Policlinico di Milano | Milan | 20122 | Italy |
| Ospedale Cervello - Bone Marrow Transplantation Unit | Palermo | Italy |
| Azienda Ospedaliera Policlinico di Verona | Verona | 37134 | Italy |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| 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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| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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