Intensive Chemo-immunotherapy as First Line Treatment in Adult Patients With Peripheral T- Cell Lymphoma (PTCL-06)

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status and phase: Completed; Phase 2

Conditions: Lymphoma, T-Cell, Peripheral

Treatments: Drug: Clin B (CHOP- CAMPATH) Chemo-immunotherapy; Procedure: Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT

Study type: Interventional

Funder types: Other

Identifiers

NCT01679860

PTCL-062006-004234-33

Details and patient eligibility

About

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).

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Clin A

Experimental group

Description:

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

Treatment:

Procedure: Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT

Clin B

Experimental group

Description:

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

Treatment:

Drug: Clin B (CHOP- CAMPATH) Chemo-immunotherapy