Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas

Prior treatment

• Prior treatment for lymphoma

Other illness

• Positive serologic markers for human immunodeficiency virus (HIV)
• Active hepatitis B virus (HBV) infection
• Active hepatitis C virus (HCV) infection
• Psychiatric disease that precludes understanding concepts of the trial or signing informed consent
• Any active, uncontrolled infection
• Prior history of malignancies other than PTCLs in the last five years (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast).

Lab values

• Levels of serum bilirubin, alkaline phosphatase and transaminases \> 2 the upper normal limit, if not disease related
• Ejection fraction \< 50% and no myocardial stroke in the last year or QT prolongation (QTc interval \> 480 msec using the Fridericia formula)
• Clearance of creatinine \< 60 ml/min if not disease related

Age

• Age \<18 e \> 65 years

Other

• Hystology other than: PTCL-NOS, AITL, ALK-ALCL
• Stage I
• Spirometry Diffusion Capacity (DLCO) \< 50%
• Pregnancy or lactation
• Patient not agreeing to take adequate contraceptive measures during the study

• Age ≥18 e ≤ 65 years
• Peripheral T-cell lymphomas at diagnosis including: PTCL-NOS, AITL including other nodal TFH, ALK-ALCL
• Stage II-IV
• Written informed consent
• No prior treatment for lymphoma
• No Central Nervous System (CNS) disease (meningeal and/or brain involvement by lymphoma)
• HIV negativity
• Absence of active hepatitis C virus (HCV) infection
• HBV negativity or patients with HBcAb +, HBsAg -, HBs Ab+/- with HBV-DNA negativity (in these patients Lamivudine prophylaxis is mandatory)
• Levels of serum bilirubin, alkaline phosphatase and transaminases \< 2 the upper normal limit, if not disease related
• No psychiatric illness that precludes understanding concepts of the trial or signing informed consent
• Ejection fraction \> 50% and myocardial stroke in the last year nor QT prolongation (QTc interval \< 480 msec using the Fridericia formula)
• Clearance of creatinine \> 60 ml/min if not disease related
• Spirometry Diffusion Capacity (DLCO) \> 50%
• Absence of active, uncontrolled infection
• For males and females of child-bearing potential, agreement upon the use of effective contraceptive methods prior to study entry, for the duration of study participation and in the following 90 days after discontinuation of study treatment
• Availability of histological material for central review and pathobiological studies.