Peripheral T-cell Lymphomas (PTCL)
Conditions
Brief summary
The objective of this study is to evaluate the efficacy and safety of golidocitinib in combination with the GemOx regimen in r/r PTCL
Interventions
DRUGgolidocitinib
150mg qd po
DRUGGEMOX
Gemcitabine: 1000mg/m2, d1; Oxaliplatin:100mg/m2, d1
Sponsors
Ruijin Hospital
Study design
Allocation
NA
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. fully understood and voluntarily signed the ICF for this study 2. aged ≥ 18 years; 3. patients with R/R PTCL who have received at least one prior systemic therapy. 4. Patients must have at least one measurable lesion by computed tomography (CT)/magnetic resonance imaging (MRI) (longest diameter of lymph node lesions \> 1.5 cm or longest diameter of extranodal lesions \> 1 cm); evaluable lesions: PET-CT examination showed increased local uptake in lymph nodes or extranodal sites (higher than liver) and imaging characteristics consistent with lymphoma performance 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; 6. Adequate bone marrow function, renal function, liver function: ANC ≥ 1.0 × 109/L, hemoglobin ≥ 8.0 g/dL, platelets ≥ 75 × 109/L Note: if the investigator believes that the patient 's above test values are below the lower limit of the protocol due to lymphoma invading the bone marrow, the patient can be enrolled after assessment.Creatinine clearance \> 40 mL/min, calculated by Cockcroft-Gault method: • serum total bilirubin ≤ 1.5 x upper limit of normal (ULN), except for unconjugated bilirubinemia in Gilbert 's syndrome; • ALP (in the absence of bone disease), ALT, and AST ≤ 3.0 × ULN (in the presence of liver metastases, ≤ 5 × ULN); • international normalized ratio (INR) ≤ 1.5 × ULN, or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 7. Current negative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV), and inactive if positive: * HBV infected patients with positive hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb)\] but negative results of HBV DNA polymerase chain reaction (PCR) test can be enrolled; these patients require continuous antiviral therapy after enrollment and HBV DNA PCR test is performed every cycle; * Patients with positive HCV serology but negative HCV RNA test may be enrolled; * CMV IgM antibody positive,However, patients who tested negative for CMV DNA could be enrolled; 8. female patients of childbearing potential had to agree to use a double contraception method at least 28 days before starting study drug, during treatment, and for 6 months after the last dose of study drug, and male patients with partners of childbearing potential had to also use an effective double contraception method during the study and for 3 months after the last dose of study drug, e.g., condom, sponge plug, foam, contraceptive jelly, diaphragm cap or intrauterine contraceptive device, contraceptive pills (oral or parenteral), contraceptive implant (Implanon ®), injectable intravascular injection, or other contraceptive measures.Postmenopausal women (\> 45 years of age and amenorrheic for \> 1 year) and surgically sterile women are exempt from this criterion.
Exclusion criteria
Patients who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | 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. | Percentage of participants with complete response partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Baseline up to data cut-off(up to approximately 2 years) | Progression-free survival was defined as the time from the date of randomization 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. |
| Complete Response Rate | 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. | Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria. |
| Duration of Response | Baseline up to data cut-off(up to approximately 2 years) | 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. |
| Overall survival | Baseline up to data cut-off(up to approximately 2 years) | Percentage of participants with complete or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria. |
| Adverse Events | Baseline up to data cut-off(up to approximately 3 years) | Adverse Events are assessed based on CTCAE v5.0 |
Contacts
Primary ContactWeili Zhao
Backup ContactShu Cheng
Outcome results
None listed