Clinical trial · Interventional
Compared the Efficacy and Safety of CDOP Combined With Chidamide and CDOP in de Novo Peripheral T Cell Lymphoma Patients
NCT03023358CI-TRIAL-00025522unknownPhase 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)
The prognosis for Peripheral T cell lymphomas (PTCL) remains poor in comparison to B cell NHL. This is largely due to lower response rates and less durable responses to standard combination chemotherapy regimens such as CHOP. Whether CDOP plus Chidamide can improve the prognosis for 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 |
| liposomal doxorubicin | Drug | — | UNRESOLVED |
| prednisone | Drug | Prednisone | ALIAS |
| vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- chidamide regimen
- description
- patients receive chidamide (30mg twice every week) po, cyclophosphamide (750mg/m2) iv on day 1, liposomal doxorubicin (30mg/m2) iv on day 1, vincristine (1.4mg/m2, max to 2mg) iv on day 1 and prednisone (100mg/d) po on day 1-5.
- interventionNames
- Drug: chidamide
- Drug: cyclophosphamide
- Drug: liposomal doxorubicin
- Drug: vincristine
- Drug: prednisone
- type
- ACTIVE_COMPARATOR
- label
- CDOP regimen
- description
- patients receive cyclophosphamide (750mg/m2) iv on day 1, liposomal doxorubicin (30mg/m2) iv on day 1, vincristine (1.4mg/m2, max to 2mg) iv on day 1 and prednisone (100mg/d) po on day 1-5.
- interventionNames
- Drug: cyclophosphamide
- Drug: liposomal doxorubicin
- Drug: vincristine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged over 18 years are eligible. * Patients must be diagnosed of de love peripheral T cell lymphoma (include PTCL not otherwise specified, angioimmunoblastic T cell lymphoma, ALK negative anapestic large cell lymphoma and enteropathy-associated T cell lymphoma). Patients must be chemo-naive. * ECOG PS of 0, 1, 2 at screening. * Serum biochemical values with the following limit: - creatine \</= 2.0 mg/dl, - total bilirubin \</= 2.0mg/dl, - transaminases (SG PT) \</= 3X ULN * Ability to understand an provide signed informed consent. Exclusion Criteria: * Presence of active systemic infection. * Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results. * Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, IUD, diaphragm, abstinence, or condoms by their partner) over the entire course of the study. * Patients whom the investigators considered were not applicable.
References
Publications (1)
- BACKGROUNDShi Y, Dong M, Hong X, Zhang W, Feng J, Zhu J, Yu L, Ke X, Huang H, Shen Z, Fan Y, Li W, Zhao X, Qi J, Huang H, Zhou D, Ning Z, Lu X. Results from a multicenter, open-label, pivotal phase II study of chidamide in relapsed or refractory peripheral T-cell lymphoma. Ann Oncol. 2015 Aug;26(8):1766-71. doi: 10.1093/annonc/mdv237. Epub 2015 Jun 23. PMID 26105599