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

• Status: Active, not recruiting
• Trial end date: 2026-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter study that includes two phases:

1. A phase I study to define the maximum tolerated dose (MTD) of Romidepsin in addition to CHOEP-21 and to test the safety and feasibility of CHOEP-21 in combination with dose escalation of Romidepsin (8, 10, 12, 14 mg). The dose level defined as MTD of Romidepsin will be used for the subsequent phase II study.

2. A phase II study to evaluate the efficacy (response rate, progression free survival and overall survival) and safety of Ro-CHOEP-21 incorporated into a treatment strategy including SCT.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Italiana Linfomi ONLUS
• Treatments: Cyclophosphamide; Doxorubicin; Etoposide; Etoposide phosphate; Liposomal doxorubicin; Prednisone; Romidepsin; Vincristine

Criteria

Inclusion Criteria:

1. Age ≥18 e ≤ 65 years

2. Peripheral T-cell lymphomas at diagnosis including: PTCL-NOS, AITL including other nodal TFH, ALK-ALCL

3. Stage II-IV

4. Written informed consent

5. No prior treatment for lymphoma

6. No Central Nervous System (CNS) disease (meningeal and/or brain involvement by lymphoma)

7. HIV negativity

8. Absence of active hepatitis C virus (HCV) infection

9. HBV negativity or patients with HBcAb +, HBsAg -, HBs Ab+/- with HBV-DNA negativity (in these patients Lamivudine prophylaxis is mandatory)

10. Levels of serum bilirubin, alkaline phosphatase and transaminases < 2 the upper normal limit, if not disease related

11. No psychiatric illness that precludes understanding concepts of the trial or signing informed consent

12. Ejection fraction > 50% and myocardial stroke in the last year nor QT prolongation (QTc interval < 480 msec using the Fridericia formula)

13. Clearance of creatinine > 60 ml/min if not disease related

14. Spirometry Diffusion Capacity (DLCO) > 50%

15. Absence of active, uncontrolled infection

16. 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

17. Availability of histological material for central review and pathobiological studies.

Exclusion Criteria:

1. Age <18 e > 65 years

2. Hystology other than: PTCL-NOS, AITL, ALK-ALCL

3. Stage I

4. Prior treatment for lymphoma

5. Positive serologic markers for human immunodeficiency virus (HIV)

6. Active hepatitis B virus (HBV) infection

7. Active hepatitis C virus (HCV) infection

8. Levels of serum bilirubin, alkaline phosphatase and transaminases > 2 the upper normal limit, if not disease related

9. Ejection fraction < 50% and no myocardial stroke in the last year or QT prolongation (QTc interval > 480 msec using the Fridericia formula)

10. Clearance of creatinine < 60 ml/min if not disease related

11. Spirometry Diffusion Capacity (DLCO) < 50%

12. Pregnancy or lactation

13. Patient not agreeing to take adequate contraceptive measures during the study

14. Psychiatric disease that precludes understanding concepts of the trial or signing informed consent

15. Any active, uncontrolled infection

16. 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).