T-cell Lymphomas
Conditions
Brief summary
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
DRUGGW5282 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.
DRUGConventional CHOP regimen
CHOP regimen includes the administrations of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone.
Sponsors
Dizal Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent; 2. Adult ≥ 18 years of age; 3. ECOG performance status score ≤ 2; 4. Life expectancy of not less than 12 weeks; 5. Histopathologically confirmed diagnosis of PTCL; 6. Presence of measurable disease; 7. Adequate bone marrow function and vital organ function reserve; 8. Ability to comply with study requirements and to complete study-related procedures; 9. Adequate contraception during participation in the trial.
Exclusion criteria
1. Presence of unresolved drug-related adverse events greater than Grade 1; 2. Lymphoma involving the central nervous system; 3. Failure to complete the required washout period for other anti-tumor therapies; 4. Corticosteroid use that does not meet protocol requirements; 5. Major surgery/trauma within a short period, or planned major surgery within a short period; 6. Vaccination with a live vaccine within a short period; 7. Inability to discontinue prohibited medications; 8. Requirement for immunosuppressive agents or biologics due to an underlying disease; 9. Presence of active infection; 10. Significant cardiovascular disease; 11. Presence of gastrointestinal disease that might affect drug intake or absorption; 12. History of other malignancies; 13. Known allergy to the study drug; 14. Other severe or uncontrolled systemic diseases; 15. Personnel with a conflict of interest (e.g., site staff, sponsor employees); 16. Pregnant or breastfeeding women; 17. Inability to comply with protocol requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). | The DLT observation period is defined as the 21 days after the first dose. | To evaluate the safety and tolerability of the combination of GW5282 and golidocitinib. Dose Limiting Toxicity (DLT) was evaluated in the DLT observation frame. |
| Part B: Complete Response Rate (CRR) According to Lugano 2014 by Investigators' Review | Up to 6 cycles, each cycle is 21 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Plasma concentration of GW5282 and golidocitinib | C1D1, C1D15, and Day 1 of Cycle 2~9 | To characterize the pharmacokinetics of GW5282 and golidocitinib when orally given together |
| Part A: Efficacy parameters | through the study completion, an average of around 1~2 years | To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Objective Response Rate (ORR) |
| Part B: Other efficacy parameters | through the study completion, an average of around 1~2 years | To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: ORR |
| Part B: Adverse Events (AEs) / Serious Adverse Events (SAEs) | through the study completion, an average of around 1~2 years | 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. |
| Part B: Plasma concentration of GW5282 and golidocitinib | C1D1, C1D15, and Day 1 of subsequent cycles till treatment discontinuation | To characterize the pharmacokinetics of GW5282 and golidocitinib when orally given together |
Countries
China
Contacts
CONTACTJingrun Li
Outcome results
None listed