Peripheral T-cell Lymphoma
Conditions
Brief summary
This is a phase 3, open-label, randomized, multinational study to evaluate the anti-tumor efficacy of golidocitinib versus investigator's choice in adult patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL). This study will treat patients with pathologically confirmed PTCL who have relapsed after or been refractory/intolerant to at least one prior systemic treatment regimen(s).
Interventions
DRUGGolidocitinib
150 mg, orally, once daily, with or without food, in a 21-day cycle
DRUGChidamide
30 mg, orally, twice a week, with an interval of no less than 3 days in a 21-day cycle
DRUGGemcitabine
1000 mg/m2, intravenous infusion, administered on Day 1, Day 8 and Day 15 of a 28-day cycle
Sponsors
Dizal Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The participants should sign the ICF and be able to comply with the relevant requirements in the ICF and protocol * Age ≥ 18 years * ECOG 0-2 score, life expectancy ≥ 12 weeks * Patients must have histologically confirmed peripheral T-cell lymphoma according to the World Health Organization classification of lymphoma. Eligible subtypes are restricted to: PTCL-not otherwise specified, NOS (PTCL, NOS), Angioimmunoblastic T-cell lymphoma (AITL), anaplastic large-cell lymphoma ALK-positive (ALCL ALK+), anaplastic large-cell lymphoma ALK-negative (ALCL ALK-), Follicular T-cell lymphoma, or PTCL with T-follicular helper (TFH) phenotype (FTCL or PTCL-TFH), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Natural killer/T-cell lymphoma (NK/TCL), Hepatosplenic T-cell lymphoma (HSTCL), Subcutaneous panniculitis-like T-cell lymphoma (SPTCL) * Progressed on, were refractory to or intolerant to at least one line of prior standard systemic therapies assessed by investigator * Adequate bone marrow reserve and organ system functions * Willing to comply with contraceptive restrictions
Exclusion criteria
* Any of previous or current treatment prohibited by protocol * Any unresolved \> grade 2 drug-related adverse events * Lymphoma involving central nervous system * Any of severe cardiac or pulmonary abnormalities * Disease condition requires immunosuppressants, biologics, or NSAIDs * Active infection * Malignancy disease within five years * Poorly controlled gastrointestinal disorder or inadequate absorption of medication * Severe or poorly controlled systemic diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) according to Lugano 2014 | The time from the date of randomization to the date of first progressive disease, death due to any cause whichever occurred first. Approximately 4 years. |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | The time from randomization to death due to any cause. Approximately 4 years. |
Countries
China, Taiwan, Thailand
Contacts
CONTACTLing Zhou
PRINCIPAL_INVESTIGATORZhao
Ruijin Hospital
Outcome results
None listed