Relapsed/Refractory Peripheral T-cell Lymphoma AZD4205, Golidocitinib, Relapsed/Refractory Peripheral T-cell Lymphoma, JACKPOT19
Conditions
Interventions
Golidocitinib (150 mg, orally, once daily [QD], with or without food, in a 21-day cycle),Investigators choice (according to the approval status and availability of drugs in different countries or regi
or pralatrexate, 30 mg/m2, intravenous push, once weekly for 6 weeks in 7-week cycles
or gemcitabine, 1000 mg/m2, intravenous infusion, administered on Day 1, Day 8 and Day 15 of a 28-day cycle
or belinostat, 1000 mg/m2, intravenous infusion, administered QD on Day 1 to Day 5 of a 21-day cycle)
Experimental Drug,Active Comparator Drug
Golidocitinib,Investigators choice
Sponsors
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.The participants should sign the ICF according to the relevant procedures described in this section and be able to comply with the relevant requirements and restrictions listed in the ICF and this study protocol. 2.The participants must be greater than or equal to 18 years of age when signing the ICF. 3.The participants ECOG performance score must be 0 - 2, with no deterioration in the past two weeks. 4.The participants life expectancy should be greater than or equal 12 weeks per the investigators judgment. 5.Participants must have histologically confirmed PTCL by the study site according to the WHO classification criteria of lymphoma (Alaggio R et al. 2022). The histological subtype of the participants to be included should be representative and reflect the epidemiological distribution. Eligible respective histological subtypes are restricted to the following- -PTCL, NOS -AITL -ALCL ALK + -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) -NK/TCL -Hepatosplenic T-cell lymphoma (HSTCL) -Subcutaneous panniculitis-like T-cell lymphoma (SPTCL) 6.Progressed on, were refractory to or intolerant to at least one line of prior standard systemic therapies assessed by investigator (in participants with CD30 positive ALCL, the prior systemic treatment should include CD30-targeted therapy (such as BV) if the therapy is approved and available as standard therapy, unless in the judgment of the investigator such treatment was otherwise contraindicated, in participants with NK/TCL, the prior systemic treatment should include asparaginase/pegaspargase/L-asparaginase, unless allergic to asparaginase) after at least one line of standard systemic therapy for PTCL, as judged by the investigator. Participants should be transplant-ineligible (autologous or allogeneic) upon entering this study. 7.Adequate bone marrow hematopoietic function reserves and organ system functions, as outlined below -Absolute neutrophil count (ANC) greater than or equal to 1.5 x 1000000000/L (greater than or equal to 1.0 x 1000000000/L if baseline bone marrow involvement) without granulocyte colony-stimulating factor (G-CSF) within seven days before entering the study -Platelet count greater than or equal to 100 x 1000000000/L (greater than or equal to 50 x 1000000000/L if baseline bone marrow involvement) without G-CSF or blood transfusion within seven days before entering the study -Hemoglobin greater than or equal to 8 g/dL without blood transfusion or using erythropoietin within seven days before entering the study -Total bilirubin less than or equal to 1.5 x ULN (less than or equal to 3 x ULN in case of Gilbert syndrome or baseline liver involvement) -Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 x ULN -Gamma-glutamyltransferase less than or equal to 2.5 x ULN -Creatinine less than or equal to 1.5 x ULN, or calculated or measured creatinine clearance greater than or equal to 50 mL/min by the Cockcroft-Gault method, or 24-hour urine creatinine clearance greater than or equal 50 mL/min. 8.Left ventricular ejection fraction (LVEF) greater than or equal to 50percent by multiple-gated acquisition (MUGA) scan or by echocardiography (ECHO). 9.Paticipants should have the ability and willingness to comply with the study and follow-up. 10.If the
Exclusion criteria
Exclusion criteria: 1.Any of the following treatment history: -Participants who have received investigational products or study drugs in other projects within 30 days before the first dose in this study; -Cytotoxic chemotherapy drugs have not been discontinued within 21 days before the first dose in this study; -Participants who have received steroid hormones at dosages equivalent to prednisone more than 15 mg/day within one week before the first dose in this study; -Participants who have undergone major surgery (excluding vascular access surgery) or severe trauma within four weeks before the start of administration in this study; or participants who are expected to have surgery after the first dose in this study; -Participants who have received anti-tumor macromolecular antibody drugs (including BV) within four weeks; radiotherapy within three weeks; other toxin/isotope-immune antibody conjugates within ten weeks before the first dose in this study; -Previous history of allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within three months; -Participants who have received anti-cancer immunotherapy (e.g., immune checkpoint inhibitors, including PD-1, PD-L1, and CTLA-4) within 28 days before the first dose in this study. Participants treated with other types of new drugs need to be evaluated by both investigator and sponsors study physician before enrollment; -Participants who have been vaccinated with live vaccines within 28 days before the first dose in this study; -Participants who are currently using vitamin K antagonists, antiplatelet drugs, and anticoagulant drugs (or unable to discontinue use within one week before the first dose in this study); -Participants who are currently using (or unable to discontinue use within one week before the first dose in this study) certain known drugs, herbs, or supplements that may strongly induce or inhibit CYP3A (see Appendix G for details); 2.Participants who have used JAK or STAT3 inhibitors during previous PTCL treatment; prior use of all four drugs in Arm 2 (chidamide, pralatrexate, gemcitabine, belinostat). 3.Any unresolved more than grade 2 drug-related AEs before the first dose in this study. 4.Participants with lymphoma involving the central nervous system and/or meninges confirmed by previous imaging and/or clinically indicated. 5.Participants with significantly impaired lung function (i.e., lung function tests show FEV1 and DLCO less than 60percent of predicted values). Participants with a prior history of non-infectious pneumonitis, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence showing clinically active interstitial lung disease. 6.Participants with diseases or conditions requiring treatment with immunosuppressive agents, similar biological agents, or non-steroidal anti-inflammatory drugs (NSAIDs). 7.Active infection within 30 days, including but not limited to: -Known active tuberculosis, such as tuberculin (PPD) test positive (induration > 10 mm in diameter), T-SPOT test positive, tuberculosis lesions found on chest X-ray/CT, or other positive results found based on routine clinical screening (except that resolved as assessed by the investigator after standard anti-tuberculosis therapy) -Known human immunodeficiency virus (HIV) infection or virological hepatitis serological marker status -Infections requiring oral or intravenous antibacterial, antifungal, antiviral
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival assessed by Independent Review Committee (IRC) Evaluations will be performed every 9 weeks and every 18 weeks after 12 months from randomization until the PD assessed by IRC or death. Measurement by CT scan, bone marrow aspiration biopsy and PET scan, from the date of randomization to date of PD assessed by IRC or death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival From randomization to every 3 months after PD until death From randomization until death or censoring ,Objective response rate assessed by Independent Review Committee Evaluations will be performed every 9 weeks and every 18 weeks after 12 months from randomization until PD assessed by IRC, lost to follow-up, death or withdrawal of informed consent by participants. Proportion of participants who achieve a CR or PR assessed by IRC.,Complete response rate assessed by Independent Review Committee Evaluations will be performed every 9 weeks and every 18 weeks after 12 months from randomization until PD assessed by IRC, lost to follow-up, death or withdrawal of informed consent by participants Proportion of participants who achieve a CR assessed by IRC,Duration of response assessed by Independent Review Committee Evaluations will be performed every 9 weeks and every 18 weeks after 12 months from randomization until PD assessed by IRC, lost to follow-up, death or withdrawal of informed consent by participants From the date of initial documentation of a response to the date of PD assessed by IRC or death.,Progression-free survival assessed by investigator Evaluations will be performed every 9 weeks and every 18 weeks after 12 months from randomization until the PD assessed by investigator or death. Measurement by CT scan, bone marrow aspiration biopsy and PET scan, from the date of randomization to date of PD assessed by investigator or death.,Objective response rate assessed by investigator Evaluations will be performed every 9 wks and every 18 wks after 12 months from randomization until the PD assessed by inv., lost to follow-up, death or withdrawal of informed consent by participants Proportion of participants who achieve a CR or PR assessed by investigator.,Complete response rate assessed by investigator Evaluations will be performed every 9 wks and every 18 wks after 12 months from randomization until the PD assessed by inv., lost to follow-up, deat | — |
Countries
Thailand
Contacts
Public ContactQian Zhu
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Outcome results
None listed