Clinical trial · Interventional
Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas
Romidepsin in Combination With CHOEP as First Line Treatment Before Hematopoietic Stem Cell Transplantation in Young Patients With Nodal Peripheral T-cell Lymphomas: a Phase I-II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALK- Anaplastic Large Cell Lymphoma (ALCL) | Anaplastic Large Cell Lymphoma | ALIAS | 0.85 |
| Angioimmunoblastic T-cell Lymphoma (AITL) | Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type | ALIAS | 0.85 |
| Nodal Peripheral T-Cell Lymphoma of T Follicular Helper Cell Origin | Follicular Helper T-Cell Lymphoma | ALIAS | 0.90 |
| Peripheral T-cell Lymphomas (PTCL) | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.85 |
| PTCL-NOS | Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ro-CHOEP-21 (PHASE I) | Drug | — | UNRESOLVED |
| Ro-CHOEP-21 (PHASE II) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ro-CHOEP-21
- description
- During the Phase I It will administered Romidepsin (dose escalation) and the combination of CHOEP-21. During the Phase II It will administered Romidepsin (dose according to phase I) and the combination of CHOEP-21.
- interventionNames
- Drug: Ro-CHOEP-21 (PHASE I)
- Drug: Ro-CHOEP-21 (PHASE II)
Primary outcomes (2)
- measure
- Dose-limiting toxicity (DLT) of Ro-CHOEP-21 (Phase I endpoint)
- timeFrame
- 3 months
- description
- Incidence of dose-limiting toxicity (DLT) of Ro-CHOEP-21, considering as maximum dose the one causing induction of any grade ≥ 3 non hematologic toxicity or a delay \>15 days of planned cycle date observed during the first two cycles according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (2009)
- measure
- Progression Free Survival (PFS) of Ro-CHOEP-21 (Phase II endpoint)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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).
References
Publications (0)
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