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This is a phase 1/2 open-label study to evaluate GW5282 in combination with golidocitinib (G2 regimen) for the treatment of T-cell lymphoma. In the first phase of the study, the maximum tolerated dose will be determined through dose escalation; in the second phase, the potential therapeutic advantages of the novel combination therapy over the conventional CHOP regimen will be preliminarily assessed through a randomized controlled design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation cohorts (Part A, non-randomized) | Experimental |
| |
| Dose expansion cohorts (Part B, randomized) | Experimental |
| |
| Control cohort (Part B, randomized) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW5282 combined with Golidocitinib | Drug | GW5282 and Golidocitinib will be administered in combination as twice daily (BID) and once daily (QD), respectively. The starting dose will be GW5282 40 mg BID combined with golidocitinib 150 mg QD. If tolerated, the dose of GW5282 will be subsequently escalated. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). | To evaluate the safety and tolerability of the combination of GW5282 and golidocitinib. Dose Limiting Toxicity (DLT) was evaluated in the DLT observation frame. | The DLT observation period is defined as the 21 days after the first dose. |
| Part B: Complete Response Rate (CRR) According to Lugano 2014 by Investigators' Review | To evaluate anti-tumor activity of GW5282 combined with golidocitinib as a chemo-free induction therapy for newly diagnosed PTCL, and compare it with conventional CHOP regimen. | Up to 6 cycles, each cycle is 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Plasma concentration of GW5282 and golidocitinib | To characterize the pharmacokinetics of GW5282 and golidocitinib when orally given together | C1D1, C1D15, and Day 1 of Cycle 2~9 |
| Part A: Efficacy parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingrun Li | Contact | +86-21-61097800 | jingrun.li@dizalpharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing Cancer Hospital | Not yet recruiting | Chongqing | Chongqing Municipality | China |
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|
| GW5282 combined with Golidocitinib | Drug | GW5282 and Golidocitinib will be administered at the doses determined during escalation part. |
|
| Conventional CHOP regimen | Drug | CHOP regimen includes the administrations of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone. |
|
To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Objective Response Rate (ORR)
| through the study completion, an average of around 1~2 years |
| Part A: Efficacy parameters | To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Complete Response Rate (CRR) | through the study completion, an average of around 1~2 years |
| Part A: Efficacy parameters | To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Duration of Response (DoR) | through the study completion, an average of around 1~2 years |
| Part A: Efficacy parameters | To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Progression Free Survival (PFS) | through the study completion, an average of around 1~2 years |
| Part B: Other efficacy parameters | To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: ORR | through the study completion, an average of around 1~2 years |
| Part B: Other efficacy parameters | To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: DoR | through the study completion, an average of around 1~2 years |
| Part B: Other efficacy parameters | To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoints: PFS. | through the study completion, an average of around 1~2 years |
| Part B: Adverse Events (AEs) / Serious Adverse Events (SAEs) | To determine the safety and tolerability of GW5282 combined with golidocitinib: Number of Participants With AEs, Number of Participants With SAEs. Using investigator reported AEs according to CTCAE and SAE criteria. | through the study completion, an average of around 1~2 years |
| Part B: Plasma concentration of GW5282 and golidocitinib | To characterize the pharmacokinetics of GW5282 and golidocitinib when orally given together | C1D1, C1D15, and Day 1 of subsequent cycles till treatment discontinuation |
| Fujian Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | China |
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| Guangxi Medical University Cancer Hospital | Not yet recruiting | Nanning | Guangxi | China |
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| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | China |
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| Nanjing Drum Tower Hospital | Not yet recruiting | Nanjing | Jiangsu | China |
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| West China Hospital of Sichuan University | Not yet recruiting | Chengdu | Sichuan | China |
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| Taizhou Hospital of Zhejiang Province | Not yet recruiting | Taizhou | Zhejiang | China |
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| The First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | Wenzhou | Zhejiang | China |
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| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
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| Shanxi Provincial Cancer Hospital | Not yet recruiting | Taiyuan | China |
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| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | China |
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| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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