B-cell lymphoma
Conditions
Interventions
treatment:HBW-3220capule
Sponsors
Tianjin Medical University Cancer Institute and Hospital/Sun Yat-sen University Cancer Center (SYSUCC)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The estimated survival is >=3 months according to the investigators. 2. Eastern Cooperative Oncology Group (ECOG) performance score =0.75 x 10^9 / L, and no growth factor is required. With bone marrow involvement, a growth factor can be used at any time prior to C1D1 to reach the 0.75 x 10^9/L threshold; blood transfusion support is not required for the platelet count of >=75 x 10^9/L.If bone marrow involvement is >=50 x 10^9/L, platelet infusion or growth factor can be used to reach the 50 x 10^9 / L threshold 7 days before C1D1; hemoglobin (Hb) >=80g/L not requiring transfusion support or growth factors; if there is documented bone marrow involvement, growth factors (e.g., epoetin alpha) may be used at any time prior to C1D1 to achieve this Hb threshold. 6. Adequate coagulation, defined as activated partial thromboplastin time (aPTT) and prothrombin time (PT) (international normalized ratio [INR]) not greater than 1.5 x upper limit of normal (ULN). 7. Adequate hepatic function, defined as ALT or AST = 60 mL/ minute using CKD-EPI.
Exclusion criteria
Exclusion criteria: 1.Treated with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducersand/or strong P-gp inhibitors within 7 days before the initiation of HBW-3220 treatment.Includes the following drugs: medium potent CYP3A4 inhibitors such as fluconazole, ketoconazole, and clarithromycin, and medium potent potent CYP3A4 inducers such as rifampicin, carbamazepine, phenytoin, and St. John's wort. 2.Have received investigational drugs or anticancer treatment within 5 half-life or 28 days (whichever is shorter but not less than 7 days) before starting HBW-3220 treatment, including traditional Chinese medicine, chemotherapy, endocrine therapy, and major surgery, such as at least 15 days, venecra, at least 22 days, BTK inhibitors [ibrutinib, zebtinib, etc.], lenalidomide and lenalidomide for at least 7 days). 3.Continuation of certain standard of care anticancer therapies. 4.Major surgery within 4 weeks prior to planned start of HBW-3220(Vascular access catheterization or biopsy was not included). 5.Radiotherapy or whole-brain radiation in the pelvis, skull or sternum (bone marrow containing area) within 28 days before starting HBW-3220 treatment; palliative radiation in other local irradiation areas within 7 days. 6.Anticoagulation therapy such as warfarin or vitamin K antagonists is required within 28 days before or during the study, or it has a bleeding tendency or coagulation disorder. 7.Any unresolved toxicities from prior therapy greater than CTCAE (version 5.0) Grade 2 at the time of starting study treatment except for alopecia,except for hair loss. 8.High-dose glucocorticoids (equivalent: prednisone 20 mg/d) or were used for 28 days prior to starting HBW-3220 treatment, but allow topical use (e. g., nasal spray, inhalation) or temporary corticosteroids (e. g., asthma, chronic obstructive pneumonia). 9. Known central nervous system (CNS) involvement by lymphoma. 10.History of allogeneic or autologous stem cell transplant (SCT) or CAR-T therapy within the last 100 days (180 days before the PK trigger) or with any of the following: a. active graft versus host disease (GVHD) b. cytopenias from incomplete blood cell count recovery post-transplant c. need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity > Grade 1 from CAR-T therapy d. ongoing immunosuppressive therapy 11.Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])The new treatment or the original treatment needs to be increased within 28 days prior to the enrollment study to maintain an adequate blood count. 12.Significant cardiovascular disease. 13.At least 2 out of 3 consecutive electrocardiograms (ECGs) during screening showed heart rate corrected QT interval (QTcF) prolonged to > 470 msec. QTcF is calculated using Fridericias Formula (QTcF): QTcF=QT/(RR^0.33). 14.Previous or current history of severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impaired lung function, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose,MTD;Dose-limiting toxicity,DLT;Overall Response Rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response,DOR;Time to response,TTR;Progression-free survival,PFS;Overall survival,OS;Partical Response,PR;Complete response,CR;Disease control rate,DCR;Tmax;Cmax;t1/2;CL/F;Vd/F;AUC; | — |
Countries
China
Contacts
Public ContactHuilai Zhang
Outcome results
None listed