Clinical trial · Interventional
Azacitidine Combined With Chidamide in the Treatment of Newly Diagnosed PTCL Unfit for Conventional Chemotherapy
The Efficacy and Safety of Azacitidine in Combination With Chidamide in the Treatment of Newly Diagnosed Peripheral T-Cell Lymphoma Unfit for Conventional Chemotherapy
NCT04480125CI-TRIAL-00057921unknownPhase 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 prospective, open-label, single-arm study will evaluate the efficacy and safety of azacitidine in combination with chidamide in treatment of newly diagnosed peripheral T-cell lymphoma unfit for conventional chemotherapy.
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 |
|---|---|---|---|
| Peripheral T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 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
- Aza+Chida
- description
- Azacitidine ivgtt D1-7 Chindamide 30mg,PO,twice a week Every 21 days for total 6 courses
- interventionNames
- Drug: Azacitidine
- Drug: Chidamide
Primary outcomes (1)
- measure
- Complete response rate
- timeFrame
- At the end of Cycle 6 (each cycle is 21 days)
- description
- Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Secondary outcomes (7)
- measure
- Overall response rate
- timeFrame
- At the end of Cycle 6 (each cycle is 21 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed peripheral T-cell lymphoma based on 2016 WHO classification * Treatment naive * Age ≥ 18 years * Unfit for converntional chemotherapy meeting criteria as following but not limited to: age ≥75, ECOG \>2，ADL\<100 or CCI\>1. * Must has measurable lesion in CT or PET-CT prior to treatment * Expected lifetime ≥ 3 months * Informed consented Exclusion Criteria: * Has accepted localized or systemic anti-lymphoma treatment * Has accepted autologous Stem cell transplantation before * History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix prior to study treatment * Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease * Primary CNS lymphoma * Left EF≤ 50% * Lab at enrollment (Unless caused by lymphoma): Neutrophile\<1.5\*10\^9/ L ;Platelet\<75\*10\^9/L; ALT or AST \>2\*ULN; Creatinine\>1.5\*ULN * Other uncontrollable medical condition that may that may interfere the participation of the study * Not able to comply to the protocol for mental or other unknown reasons * Patients with mentally disorders or other reasons unable to fully comply with the study protocol * Pregnant or lactation * HIV infection * HBV-DNA and HCV-RNA undectable.
References
Publications (0)
Data not yet available
No reference posted for this study.