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In decades, the outcome of patients with peripherial T-cell lymphomas is dismal, especially in relapsed or refractory population. After failure to the frontline treatment, patients have limited treatment options and elderly population usually have no chance to undergo transplantation due to age or comorbidity, etc. Golidocitinib and chidamide were approved in treating r/r PTCL in China, while azacytidine has been demonstrated its anti-tumor activity in PTCL as well.
This study aims to explore the efficacy and safety of golidocitinib combined with azacytidine and chidamide in the patients with peripheral T-cell lymphoma who are eligible for intensive chemotherapy or transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| golidocitinib with azacytidine and chidamide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| golidocitinib with azacytidine and chidamide | Drug | In Phase I, a "3+3" dose-escalation design will be adopted to enroll 3 to 12 participants, exploring the recommended Phase II dose (RP2D) at two dose levels of golidocitinib: 150 mg every other day (QOD) and 150 mg once daily (QD). In Phase II, we aim to evaluate the efficacy and safety of golidocitinib RP2D po in combination with chidamide 20mg biw po and azacytidine 100mg d1-7, SC in patients with peripheral T-cell lymphoma |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Percentage of participants with complete response or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria | Tumor evaluation was assessed at screening and at the end of treatment (around 3 cycles) then every 12-24 weeks until disease progression (each cycle is 21 days) through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first. | Baseline up to data cut-off(up to approximately 3 years) |
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Inclusion Criteria:
Exclusion Criteria:
Involvement of the central nervous system (CNS);
History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix;
Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
Left ventricular ejection fraction<50%
Laboratory measures meet the following criteria at screening (unless caused by lymphoma):
HIV-infected patients
Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
Pregnant or lactation
Require treatment with strong/moderate CYP3A inhibitors or inducers.
Inability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, post-bariatric surgery, inflammatory bowel disease and complete or incomplete intestinal obstruction
Other medical conditions determined by the researchers that may affect the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Li | Contact | +86 02164370045 | zwl_trial@163.com |
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| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
| Complete Response Rate |
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria. |
| Tumor evaluation was assessed at screening and at the end of treatment (around 3 cycles) then every 12-24 weeks until disease progression (each cycle is 21 days) through study completion, an average of 1 year. |
| Duration of Response | Applicable to complete or partial response participants. DoR was defined as the time from the first documented date of complete or partial response until the date of the disease progression or death from any causes. | Baseline up to data cut-off(up to approximately 3 years) |
| Overall survival | Overall survival was defined as the time from the date of enrollment to the date of death from any cause. | Baseline up to data cut-off(up to approximately 3 years) |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | From enrollment to study completion, a maximum of 4 years |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |