Clinical trial NCT01679860: Intensive Chemo-immunotherapy as First Line Treatment in Adult Patients With Peripheral T- Cell Lymphoma
Official title: Intensive Chemo-immunotherapy as First-line Treatment in Adult Patients With Peripheral T-cell Lymphoma (PTCL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, T-Cell, Peripheral
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2012-09-06
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Efficacy
timeFrame: one year
Secondary outcomes:
measure: evaluation of OS (overall survival)
timeFrame: 4 years
measure: DFS (Disease Free Survival)
timeFrame: 4 years
measure: TRM (Treatment Related Mortality)
timeFrame: 4 years
Other outcomes:
Locations:
city: Orbassano
country: Italy
facility: Azienda Ospedaliera S. Luigi
state: Torino
city: Alessandria
country: Italy
facility: Ospedale SS. Antonio e Biagio e Cesare Arrigo
city: Ancona
country: Italy
facility: University of Ancona - Division of Hematology
city: Bergamo
country: Italy
facility: Ospedale Riuniti, Bergamo - Division of Hematology
city: Bolzano
country: Italy
facility: Ospedale Generale Regionale Bolzano
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: Catania
country: Italy
facility: Azienda Ospedale Vittorio Emanuele Ferrarorro S. Bambino- Università di Catania
city: Cuneo
country: Italy
facility: Ospedale S. Croce - Division of Hematology
city: Milano
country: Italy
facility: IRCCS Ospedale Maggiore Policlinico di Milano
city: Milan
country: Italy
facility: Ospedale San Raffaele, Milano - Division of Hematology
city: Milan
country: Italy
facility: Division of Hematology - Fondazione IRCCS Istituto Nazionale Tumori
city: Palermo
country: Italy
facility: Ospedale Cervello - Bone Marrow Transplantation Unit
city: Potenza
country: Italy
facility: Ospedale San Carlo
city: Torino
country: Italy
facility: Azienda OspedalieraSan Giovanni Battista
city: Torino
country: Italy
facility: Università di Torino- Azienda Ospedaliera S. Giovanni Battista
city: Udine
country: Italy
facility: Policlinico Universitario Udine
city: Verona
country: Italy
facility: Azienda Ospedaliera Policlinico di Verona
Study officials:
affiliation: fondazione IRCCS istituto nazionale tumori Milano
name: paolo corradini
role: PRINCIPAL_INVESTIGATOR
References: