Clinical trial · Interventional
Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma (PET: Prednisone, Etoposide and Thalidomide)
Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma, a Multicentric, Single Arm, Open Label Phase II Clinical Trial
NCT03273452CI-TRIAL-00029634PETunknownPhase 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 study aims to investigate the efficacy and safety of PET regimen combined with Chidamide for angioimmunoblastic T cell lymphoma patients.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment group
- description
- In this group, patients will be given prednisone 100mg,qd,d1-5; etoposide 100mg,qd,d1-5; thalidomide 100mg,qn,d1-14; Chidamide 30mg,biw;
- interventionNames
- Drug: Chidamide
Primary outcomes (1)
- measure
- Objective remission rate(ORR)
- timeFrame
- every 3 months until 24 months after the last patient's enrollment
- description
- the rate of patients who achieve objective remission after the treatment,including CR (complete remission),CRu (complete remission with unrecovered platelet count) and PR (partial remission).
Secondary outcomes (3)
- measure
- duration of remission
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically diagnosed as angioimmunoblastic T cell lymphoma (diagnosed by pathologic department in IIIA hospitals or verified by certified institutions), immunohistochemistry should include: CD3, CD4, CD8, CD20, CD10, CD21, CD35, Bcl6, CXCL13, EBER, PD-1, Ki67. 2. At least on measurable focus (≥1.0\*1.0cm by imaging), or at least one evaluable focus; 3. Age 18-75 years, both male and female; 4. ECOG 0-2, KPS≥ 70points; 5. Expected survival ≥3 months; 6. Peripheral blood neutrophil count ≥1.5×10\^9/L, platelet count≥ 75×10\^9/L, Hb≥ 90g/L; 7. Liver function: bilirubin ≤1.5 times of the normal maximum; AST、ALT≤2 times of the normal maximum (for patients with liver infiltration AST、ALT≤3 times of the normal maximum); renal function: blood creatinine ≤2 times the normal maximum; 8. Negative random pregnancy test for fertile women patients within 7 days before enrollment; 9. No radiation therapy, chemotherapy, targeted therapy nor hemopoietic stem cell transplantation within 4 weeks before enrollment; 10. No anti-tumor therapy at enrollment, including herbal therapy, immunotherapy and biologic therapy, symptomatic treatment is not within this range; Exclusion Criteria: 1. Women during pregnancy or lactation, and fertile women that are not willing to take contraceptive measurements; 2. Patients with other malignant tumors simultaneously that have not been effectively controlled; 3. Patients with history of using HDAC inhibitors; 4. Patients who are allergic to medicine used in the trial, or have metabolic disorders toward these medicine; 5. Patients with severe active infection; 6. Patients with HIV or syphilis infection; 7. Patients with prolonged QT interval (male \> 450ms,female \> 470ms), or chronic heart failure patients with level III or IV cardiac function; or those have the following heart disease within 6 months before enrollment: acute coronary syndrome, acute heart failure (heart function level III or IV), distinctive ventricular arrhythmias (prolonged ventricular tachycardia, ventricular fibrillation, etc); 8. Patients with history of organ transplantation; 9. Patients with history of thrombosis and embolism; 10. Patients with mental disorders or those who are unable to sign a written consent; 11. Patients with drug abuse or long-time alcoholism that may influence the result of the trial; 12. Patients who do not have capacity of legal transactions; 13. Patients currently in other clinical trials; 14. Those who are recognized as inappropriate for the trial by the investigators;
References
Publications (1)
- DERIVEDWang Y, Zhang M, Song W, Cai Q, Zhang L, Sun X, Zou L, Zhang H, Wang L, Xue H. Chidamide plus prednisone, etoposide, and thalidomide for untreated angioimmunoblastic T-cell lymphoma in a Chinese population: A multicenter phase II trial. Am J Hematol. 2022 May;97(5):623-629. doi: 10.1002/ajh.26499. Epub 2022 Mar 11. PMID 35170082