Intensive Chemo-immunotherapy as First Line Treatment in Adult Patients With Peripheral T- Cell Lymphoma
- Conditions
- Lymphoma, T-Cell, Peripheral
- Interventions
- Procedure: Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCTDrug: Clin B (CHOP- CAMPATH) Chemo-immunotherapy
- Registration Number
- NCT01679860
- Lead Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Brief Summary
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).
- Detailed Description
Inclusion criteria Clin A
* Age ≥18 \< or =60 years (patients older than 60 years are excluded because of the intensive chemotherapy and transplant procedures)
* Histologically proven diagnosis of PTCL, including the following categories: PTCL-U (peripheral T-cell lymphoma, unspecified), AILD-T (angioimmunoblastic-like T-cell lymphoma), ALKneg ALCL (ALK-negative anaplastic large cell lymphoma),intestinal T - NHL
* Advanced stage disease (stage II-IV) or stage I and aaIPI score ≥ 2
* Written informed consent
Inclusion criteria Clin B
* Age \>60 and ≤75 years (patients older than 75 years are excluded because of the intensive chemo-immunotherapy program)
* Histological proven diagnosis of PTCL, including the following categories: PTCL-U (peripheral T-cell lymphoma, unspecified), AILD-T (angioimmunoblastic-like T-cell lymphoma), ALKneg ALCL (ALK-negative anaplastic large cell lymphoma), intestinal T - NHL
* Advanced-stage disease (stage II-IV) or stage I and aaIPI score ≥ 2
* Informed written consent
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
- Age ≥18 <60 years (patients older than 60 years are excluded because of the intensive chemotherapy and transplant procedures)
- Histologically proven diagnosis of PTCL, including the following categories: PTCL-U (peripheral T-cell lymphoma, unspecified), AILD-T (angioimmunoblastic-like T-cell lymphoma), ALKneg ALCL (ALK-negative anaplastic large cell lymphoma),intestinal T - NHL
- Advanced stage disease (stage II-IV) or stage I and aaIPI score ≥ 2
- Written informed consent
- Histological PTCL subset other than PTCL-U, AILD-T ALCL-ALKneg, intestinal T - NHL
- Central nervous system localization
- Positive serologic markers for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infection
- Serum bilirubin levels > 2 the upper normal limit
- Clearance of creatinine < 50 ml/min
- DLCO < 50%
- Ejection fraction < 45% (or myocardial infarction in the last 12 months)
- Pregnancy or lactation
- Patient not agreeing to take adequate contraceptive measures during the study
- Psychiatric disease
- Any active, uncontrolled infection
- Type I hypersensitivity or anaphylactic reactions to proteins drugs
- Active secondary malignancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Clin A Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT 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 Clin B (CHOP- CAMPATH) Chemo-immunotherapy 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
- Primary Outcome Measures
Name Time Method Efficacy one year number of clinical responses
- Secondary Outcome Measures
Name Time Method evaluation of OS (overall survival) 4 years 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.
DFS (Disease Free Survival) 4 years 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)
TRM (Treatment Related Mortality) 4 years TRM will be analysed by computing the corresponding crude cumulative incidence curve, considering disease-related death as competing event.
Trial Locations
- Locations (17)
Spedali Civili di Brescia
🇮🇹Brescia, Italy
Ospedale SS. Antonio e Biagio e Cesare Arrigo
🇮🇹Alessandria, Italy
Policlinico Universitario Udine
🇮🇹Udine, Italy
Azienda Ospedaliera Policlinico di Verona
🇮🇹Verona, Italy
Ospedale Generale Regionale Bolzano
🇮🇹Bolzano, Italy
Ospedale S. Croce - Division of Hematology
🇮🇹Cuneo, Italy
Azienda Ospedaliera S. Luigi
🇮🇹Orbassano, Torino, Italy
Ospedale Riuniti, Bergamo - Division of Hematology
🇮🇹Bergamo, Italy
Azienda Ospedale Vittorio Emanuele Ferrarorro S. Bambino- Università di Catania
🇮🇹Catania, Italy
Azienda OspedalieraSan Giovanni Battista
🇮🇹Torino, Italy
University of Ancona - Division of Hematology
🇮🇹Ancona, Italy
IRCCS Ospedale Maggiore Policlinico di Milano
🇮🇹Milano, Italy
Division of Hematology - Fondazione IRCCS Istituto Nazionale Tumori
🇮🇹Milan, Italy
Ospedale San Carlo
🇮🇹Potenza, Italy
Ospedale San Raffaele, Milano - Division of Hematology
🇮🇹Milan, Italy
Ospedale Cervello - Bone Marrow Transplantation Unit
🇮🇹Palermo, Italy
Università di Torino- Azienda Ospedaliera S. Giovanni Battista
🇮🇹Torino, Italy