Clinical trial · Interventional
Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma
A Prospective, Multicenter, Phase III, Non-randomized Study of Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma
NCT05075460CI-TRIAL-00075859unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 prospective, multicenter, phase III study of Tucidinostat, Azacitidine combined with CHOP versus CHOP in patients with untreated peripheral T-cell lymphoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| T-cell Lymphoma | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tucidinostat, Azacitidine combined with CHOP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tucidinostat, Azacitidine combined with CHOP
- description
- Tucidinostat, Azacitidine combined with CHOP
- interventionNames
- Drug: Tucidinostat, Azacitidine combined with CHOP
- type
- ACTIVE_COMPARATOR
- label
- CHOP
- description
- CHOP
- interventionNames
- Drug: Tucidinostat, Azacitidine combined with CHOP
Primary outcomes (1)
- measure
- Overall response rate (ORR)
- timeFrame
- 6 course of treatment (each cycle is 21 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with peripheral T-cell lymphoma confirmed by primary pathology; * Age 18-70 years; * ECOG performance status ≤ 2; * Adequate bone marrow hematopoietic function: WBC \> 3.5 × 10\*9/L,ANC\>1.5 × 10\*9/L,HGB\>90g/L,PLT\>80 × 10\*9/L; * Adequate organ function: cardiac function grade 0-2 (NYHA); SpO2 \> 88% (natural condition); ALT\<3UNL,TBil\<2ULN; SCr\>60ml/min/m2; * Patients have signed the Informed Consent Form Exclusion Criteria: * ALK positive anaplastic T-cell lymphoma; * NK / T cell lymphoma, nasal type; * Uncontrolled active infection; * Acute myocardial infarction or unstable angina pectoris within 6 months; uncontrolled hypertension, symptomatic arrhythmia, etc; * Subjects who are known or suspected to be unable to comply with the study protocol; * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.