Clinical trial · Interventional
Chidamide Combined With PECM in Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
A Multicenter, Single-arm, Open II Phase Clinical Trial Evaluating the Efficacy of Chidamide Combined With Prednisone, Cyclophosphamide, Etoposide, and Methotrexate (PECM) in Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
NCT03321890CI-TRIAL-00030074unknownPhase 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)
To observe the efficacy and safety of Chidamide combined with prednisone, cyclophosphamide, etoposide and methotrexate in relapsed or refractory PTCL.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination therapy regimen
- description
- Chidamide + prednisone+cyclophosphamide+etoposide+methotrexate
- interventionNames
- Drug: Chidamide
- Drug: prednisone
- Drug: Cyclophosphamide
- Drug: etoposide
- Drug: Methotrexate
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- every 8 weeks until 2 years after last patient's enrollment
- description
- the total proportion of patients with complete response(CR or CRu)and partial response(PR)
Secondary outcomes (3)
- measure
- Duration of response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathologically confirmed peripheral T-cell lymphoma (PTCL) patients; 2. Patients who have had at least one systemic treatment (including chemotherapy, hematopoietic stem cell transplantation, etc.) who have not remission or relapsed after remission; 3. For various reasons can not be hematopoietic stem cell transplantation in patients; 4. The age of 18-75 years old, male, female open; 5. ECOG (Eastern Cooperative Oncology Group) physical scoring 0-1 points; 6. Absolute value of neutrophil≥1.5 × 109 / L, platelet≥90 × 109 / L, hemoglobin≥90g / L; 7. The expected survival time ≥ 3 months; 8. No radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation were performed within 4 weeks prior to enrollment. 9. Voluntary signature of written informed consent. Exclusion Criteria: 1. Pregnancy, breastfeeding women and unwilling to take contraceptive measures of reproductive age patients; 2. B-mode ultrasonography showed that the width of end-diastolic pericardial dark area was ≥10mm; 3. Patients receiving organ transplants; 4. Patients receiving symptomatic treatment of pre-bone marrow toxicity within 7 days prior to enrollment; 5. Patients with active bleeding; 6. Liver function abnormalities (total bilirubin\> 1.5 times the upper limit of normal, ALT( alanine aminotransferase) / AST (Aspartate aminotransferase)\> 2.5 times the upper limit of normal or hepatic involvement of ALT / AST\> 5 times the upper limit of normal), renal dysfunction Creatinine\> 1.5 times the upper limit of normal), electrolyte abnormalities; 7. Persons with mental disabilities / those who can not obtain informed consent; 8. Patients with drug abuse and long-term alcohol abuse that may affect the evaluation of test results; 9. The investigators determined that they were not fit to participate in the trial.
References
Publications (0)
Data not yet available
No reference posted for this study.