Clinical trial · Interventional
PI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma
A Single Arm, Multi-center, Phase Ib Clinical Trial of PI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma
NCT05083208CI-TRIAL-00098242terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The clinical development of parsaclisib was stopped by it's manufacturer.
Summary
Brief summary (as posted)
This is a prospective single-arm, multicenter, phase Ib clinical trial of PI3Kδ inhibitor Parsaclisib combined with chidamide for the treatment of relapsed/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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide | Drug | — | UNRESOLVED |
| Parsaclisib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PI3Kδ inhibitor Parsaclisib plus Chidamide
- description
- Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day. Chidamide is taken fixed 20mg twice a week with an interval of no less than 3 days, and taken 30 minutes after breakfast.
- interventionNames
- Drug: Parsaclisib
- Drug: Chidamide
Primary outcomes (2)
- measure
- Safety and Tolerability of Parsaclisib in Combination with Chidamide
- timeFrame
- Approximately 2 years
- description
- This outcome measure will evaluate the safety and tolerability of parsaclisib when administered in combination with chidamide. Safety will be assessed by monitoring adverse events (AEs), dose-limiting toxicities (DLTs), and other clinically significant toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE). Tolerability will be assessed based on the occurrence and severity of AEs during the trial, as well as the ability of patients to complete the treatment regimen without discontinuation due to adverse effects.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18 to 75 years old (including 18 and 75) 2. Agreeing to sign the written informed consents 3. Diagnosed as peripheral T-cell lymphoma, including peripheral T-cell lymphoma, unspecified type, anaplastic large cell lymphoma (ALK negative or positive), angioimmunoblastic T-cell lymphoma, enteropathy Related T-cell lymphoma, hepatosplenic T-cell lymphoma, γ/δ T-cell lymphoma, NK/T-cell lymphoma, and other subtypes of PTCL that the investigator judges to be suitable for participating in this study 4. Received at least first-line anti-tumor therapy in the past, whether or not Chidamide has been used 5. Having at least one measurable lesions 6. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 7. Life expectancy no less than 3 months 8. enough main organ function 9. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study 10. Agreeing to follow the trail protocol requirements Exclusion Criteria: 1. Types other than peripheral T-cell lymphoma listed in the enrollment criteria 2. Diagnosed as central nervous system lymphoma 3. Received palliative treatment for other malignant tumors in the past 2 years 4. Uncontrolled active infection 5. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months 6. The non-hematological toxicity caused by the previous anti-tumor treatment has not recovered to ≤1 grade, and the hematological toxicity has not recovered to ≤2 grade 7. Patients with a history of mental illness 8. Those who are known to be allergic to the active ingredients or excipients of the drug parsaclisib and chidamide 9. Received PI3Kδ inhibitor treatment in the past 10. Received autologous hematopoietic or allogeneic hematopoietic stem cell transplantation within 3 months 11. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) \>2 12. There are factors that affect the absorption of oral drugs 13. Pregnant or lactating women 14. Researchers determine unsuited to participate in this trial
References
Publications (0)
Data not yet available
No reference posted for this study.