Clinical trial · Interventional
Azacytidine Plus Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma
Azacytidine Combined With Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma: a Multicenter Single Arm Phase II Study
NCT05179213CI-TRIAL-00055813unknownPhase 2ClinicalTrials.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 multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with chidamide in the treatment of relapsed/refractory angioimmunoblastic 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 |
|---|---|---|---|
| Angioimmunoblastic T-cell Lymphoma | Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Chidamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Azacytidine combined with chidamide
- description
- Patients in the experimental arm will received azacytidine plus chidamide treatment. This regimen was repeated every 28 days.
- interventionNames
- Drug: Azacitidine
- Drug: Chidamide
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- 1year
- description
- ORR was defined as the proportion of patients who achieved CR or PR as their best response
Secondary outcomes (4)
- measure
- progression-free survival (PFS)
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed angioimmunoblastic T-cell lymphoma according World Health Organization (WHO) classification; * Age≥18years; * ECOG≤2; * Patients received at least one systemic treatment previously and achieved no remission or relapsed after first-line treatment; * Adequate bone marrow hematopoietic function: ANC\>1.5 × 109/L,HGB\>90g/L,PLT\>80 × 109/L; * Adequate organ function: ALT≤3 times ULN, TBil≤1.5 times ULN, SCr≥50ml/min/m2, cardiac function grade 0-2 (NYHA); Exclusion Criteria: * Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment; * Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy; * Pregnant or lactating women;
References
Publications (0)
Data not yet available
No reference posted for this study.