Clinical trial · Interventional
A Umbrella Study in R/R PTCL Guided by Molecular Subtypes
A Umbrella Study in Relapsed/Refractory Peripheral T-cell Lymphoma Guided by Molecular Subtypes
NCT05559008CI-TRIAL-00062077unknownPhase 1 / Phase 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, open-label, interventional umbrella study to evaluate the efficacy and safety of targeted therapies guided by molecular subtypes in patients with relasped or refractory peripheral 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 |
|---|---|---|---|
| Peripheral T Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| Azacitidine Injection | Drug | Azacitidine | ALIAS |
| Camrelizumab | Drug | Camrelizumab | ALIAS |
| Dasatinib | Drug | Dasatinib | ALIAS |
| Linperlisib | Drug | — | UNRESOLVED |
| SHR2554 | Drug | — | UNRESOLVED |
| Tucidinostat | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- T1 subtypes based on next generation sequencing results
- description
- T1 subtypes based on next generation sequencing results
- interventionNames
- Drug: Azacitidine Injection
- Drug: Dasatinib
- type
- EXPERIMENTAL
- label
- T2 subtypes based on next generation sequencing results
- description
- T2 subtypes based on next generation sequencing results
- interventionNames
- Drug: Azacitidine Injection
- Drug: Linperlisib
- type
- EXPERIMENTAL
- label
- T3.1 subtypes based on next generation sequencing results
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically-confirmed Peripheral T-cell lymphoma (without central nervous system involvement) 2. Relapsed or refractory disease after first line treatment 3. Availability of archival or freshly collected tumor tissue before study enrollment 4. Evaluable lesion by PET-CT or CT scan 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 6. Life expectancy greater than or equal to (\>/=) 3 months 7. Informed consent Exclusion Criteria: 1. Patients with central nervous system (CNS) lymphoma 2. History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix 3. Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases 4. Laboratory measures meet the following criteria at screening (unless caused by lymphoma): Neutrophils\<1.0×10\^9/L Platelets\<75×10\^9/L (Platelets\<50×10\^9/L in case of bone marrow involvement) ALT or AST is 2.5 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN. Creatinine is 1.5 times higher than the ULN. 5. HIV-infected patients 6. Active hepatitis infection 7. Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol 8. Pregnant or lactation 9. Other medical conditions determined by the researchers that may affect the study For T3.2 should exclude patiens with active autoimmune disease
References
Publications (0)
Data not yet available
No reference posted for this study.