Recruiting NCT07496229
Assessing Treatment of T-Cell Lymphoma With GW5282 in Combination With Golidocitinib (BEI-DOU3)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GW5282 combined with Golidocitinib, GW5282 combined with Golidocitinib, Conventional CHOP regimen.
- Who it may be relevant to
- Registry conditions: T-cell Lymphomas. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase I/II Clinical Study to Evaluate the Efficacy and Safety of GW5282 in Combination With Golidocitinib in the Treatment of T-Cell Lymphoma
Overview
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.
Interventions
- Drug GW5282 combined with Golidocitinib
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. - Drug GW5282 combined with Golidocitinib
GW5282 and Golidocitinib will be administered at the doses determined during escalation part. - Drug Conventional CHOP regimen
CHOP regimen includes the administrations of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone.
Primary outcome measures
- Part A: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). [Time 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 [Time frame: Up to 6 cycles, each cycle is 21 days]
Secondary outcome measures (10)
- Part A: Plasma concentration of GW5282 and golidocitinib [Time frame: C1D1, C1D15, and Day 1 of Cycle 2~9]
- Part A: Efficacy parameters [Time frame: through the study completion, an average of around 1~2 years]
- Part A: Efficacy parameters [Time frame: through the study completion, an average of around 1~2 years]
- Part A: Efficacy parameters [Time frame: through the study completion, an average of around 1~2 years]
- Part A: Efficacy parameters [Time frame: through the study completion, an average of around 1~2 years]
- Part B: Other efficacy parameters [Time frame: through the study completion, an average of around 1~2 years]
- Part B: Other efficacy parameters [Time frame: through the study completion, an average of around 1~2 years]
- Part B: Other efficacy parameters [Time frame: through the study completion, an average of around 1~2 years]
- Part B: Adverse Events (AEs) / Serious Adverse Events (SAEs) [Time frame: through the study completion, an average of around 1~2 years]
- Part B: Plasma concentration of GW5282 and golidocitinib [Time frame: C1D1, C1D15, and Day 1 of subsequent cycles till treatment discontinuation]
Eligibility criteria
Inclusion criteria
- Signed informed consent;
- Adult ≥ 18 years of age;
- ECOG performance status score ≤ 2;
- Life expectancy of not less than 12 weeks;
- Histopathologically confirmed diagnosis of PTCL;
- Presence of measurable disease;
- Adequate bone marrow function and vital organ function reserve;
- Ability to comply with study requirements and to complete study-related procedures;
- Adequate contraception during participation in the trial.
Exclusion criteria
- Presence of unresolved drug-related adverse events greater than Grade 1;
- Lymphoma involving the central nervous system;
- Failure to complete the required washout period for other anti-tumor therapies;
- Corticosteroid use that does not meet protocol requirements;
- Major surgery/trauma within a short period, or planned major surgery within a short period;
- Vaccination with a live vaccine within a short period;
- Inability to discontinue prohibited medications;
- Requirement for immunosuppressive agents or biologics due to an underlying disease;
- Presence of active infection;
- Significant cardiovascular disease;
- Presence of gastrointestinal disease that might affect drug intake or absorption;
- History of other malignancies;
- Known allergy to the study drug;
- Other severe or uncontrolled systemic diseases;
- Personnel with a conflict of interest (e.g., site staff, sponsor employees);
- Pregnant or breastfeeding women;
- Inability to comply with protocol requirements.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 12 centers
- Chongqing Cancer Hospital — Chongqing
- Fujian Cancer Hospital — Fuzhou
- Guangxi Medical University Cancer Hospital — Nanning
- Henan Provincial People's Hospital — Zhengzhou
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
- Nanjing Drum Tower Hospital — Nanjing
- West China Hospital of Sichuan University — Chengdu
- Taizhou Hospital of Zhejiang Province — Taizhou
- … and 4 more centers
Identifiers
NCT: NCT07496229 · GW2025EZ0002