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A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19)

RecruitingPhase 3

Sponsor: Dizal Pharmaceuticals

Conditions: Peripheral T-cell Lymphoma

Interventions: Golidocitinib, Chidamide, Gemcitabine

Countries: China, Taiwan, Thailand

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (51)

Hefei, Anhui, China
Hefei, Anhui, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Chongqing, Chongqing Municipality, China
Fuzhou, Fujian, China
Xiamen, Fujian, China
Lanzhou, Gansu, China
Lanzhou, Gansu, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Nanning, Guangxi, China
Harbin, Heilongjiang, China
Zhengzhou, Henan, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Changchun, Jilin, China
Shenyang, Liaoning, China
Jinan, Shandong, China
Linyi, Shandong, China
Shanghai, Shanghai Municipality, China
Shanghai, Shanghai Municipality, China
Taiyuan, Shanxi, China
Xi’an, Shanxi, China
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