Not provided
Not provided
Not provided
Not provided
Not provided
The clinical development of parsaclisib was stopped by it's manufacturer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PI3Kδ inhibitor Parsaclisib plus Chidamide | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parsaclisib | Drug | Phase Ib: Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day. This stage follows the traditional "3+3" model. Parsaclisib is set at 10 mg/day, 15 mg/day, 20 mg/day 3 dose groups, starting from 10 mg/day, each group included 3 subjects. The final dose determined at this stage will be used in the Phase II study. Patients without progression or unacceptable toxicity after 8 weeks enter maintenance treatment. Maintain treatment: 2.5mg orally every day continuously, at approximately the same time every day, without food restriction, once a day until disease progression, death or unacceptable toxicity developments. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Parsaclisib in Combination with Chidamide | 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. | Approximately 2 years |
| Recommended Phase 2 Dose (RP2D) of Parsaclisib in Combination with Chidamide | This outcome measure will determine the recommended Phase 2 dose (RP2D) of parsaclisib when combined with a fixed dose of 20 mg of chidamide administered twice weekly (BIW). The RP2D will be determined based on dose escalation, safety data, and the tolerability observed in the Phase Ib portion of the study. The RP2D will be the highest dose level at which no more than 33% of patients experience dose-limiting toxicities (DLTs) within the first treatment cycle. | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The objective response rate will be calculated by dividing the number of patients who achieve CR or PR by the total number of patients in the study population. | Through study completion, approximately 2 years |
| Complete Response Rate (CRR) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between baseline tumor gene mutation profile and clinical efficacy (CRR, PFS, OS) | Baseline tumor tissue will be analyzed using a targeted next-generation sequencing (NGS) panel to determine the tumor gene mutation profile, including the presence of predefined somatic mutations. Clinical efficacy will be evaluated by complete response rate (CRR), progression-free survival (PFS), and overall survival (OS). The correlations between baseline tumor gene mutation profile and CRR, PFS, and OS will be explored using appropriate statistical methods (Fisher's Exact Test). |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yanyan Liu, M.D. Ph.D | Henan Cancer Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university | Zhengzhou | Henan | China |
Not provided
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C000656179 | parsaclisib |
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Chidamide | Drug | Phase Ib: Chidamide is taken fixed 20mg twice a week with an interval of no less than 3 days, and taken 30 minutes after breakfast, until progression or intolerance. |
|
CRR will be reported as the proportion of patients who achieve CR among the total number of patients treated. |
| Through study completion, approximately 2 years |
| 1-year progression-free survival | the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first | from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment (each cycle is 28 days). |
| 1-year overall survival | from date of first day of treatment to the date of death by any cause | from date of the first cycle of treatment to the date of death from any cause, assessed up to 2 years after last patient's enrollment (each cycle is 28 days). |
| Through study completion, approximately 2 years |
| Correlation between tumor microenvironment characteristics assessed by single-cell sequencing, flow cytometry and clinical efficacy (CRR, PFS, OS) | Tumor microenvironment characteristics will be assessed using single-cell sequencing and flow cytometry of tumor tissue and peripheral blood cells obtained at baseline (and, if available, at on-treatment time points). Parameters of interest include the composition and abundance of immune cell subsets (e.g., CD8+ T cells, regulatory T cells, NK cells, macrophage subpopulations) and their gene-expression signatures. These variables will be quantified as the proportion of each cell subset among total viable cells (%) or as gene-expression scores. Clinical efficacy will be evaluated by CRR, PFS, and OS as defined in the protocol. The correlations between tumor microenvironment features and clinical efficacy outcomes (CR and non-CR) will be explored using appropriate statistical methods (Independent t-test, Mann-Whitney U test, or ANOVA-two way). | Through study completion, approximately 2 years |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |