Relapsed or refractory follicular lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, lymphoplasmacytoid lymphoma/Waldenstr?m macroglobulinemia, and marginal zone lymphoma
Conditions
Interventions
Treatment Group of FL:Intravenous drip of BEBT-908
Treatment Group of CLL/SLL:Intravenous drip of BEBT-908
Treatment Group of LPL/WM:Intravenous drip of BEBT-908
Treatment Group of MZL:Intravenous drip of BEBT-908
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.The subject is willing to sign the informed consent form (ICF) after a comprehensive understanding; 2.Aged >= 18 years, male or female; 3.Histological diagnosis (need to be confirmed by central pathology), meet any of the following: follicular lymphoma, grade 1-2-3a; absolute lymphocyte count of small lymphocytic lymphoma 3 months; 6.ECOG score 0-2 points; 7.For patients with non-WM,at least one measurable and evaluable tumor lesion (according to Lugano 2014 response evaluation criteria), and for patients with splenic MZL, intrasplenic lesions can be used as measurable and evaluable tumor lesions, and patients with CLL must also meet the need for treatment for activity; in addition, for patients with WM,immunoglobulin M (IgM) >= 2 x ULN and positive serum immunofixation electrophoresis must be present; 8.Organ function level must meet the following requirements: peripheral blood:absolute neutrophil count (ANC) >= 1.0 x 10^9/L; hemoglobin (HGB) >= 80g/L; platelet count (PLT) >= 75 x 10^9/L;liver and kidney function:serum total bilirubin <= 1.5 x ULN;serum creatinine < 1.5 x ULN; ALT and AST <= 2.5 x ULN, or liver infiltration leading to impaired liver function and ALT and AST <= 5 x ULN as judged by the investigator.
Exclusion criteria
Exclusion criteria: 1.Previous history of other malignancies other than indolent B-cell lymphoma,except for the following:appropriately treated basal cell or squamous cell carcinoma of the skin,cervical carcinoma in situ,superficial bladder cancer,localized prostate cancer,other appropriately treated stage 1 or 2 cancers in complete response,or any other cancer in complete response for more than 5 years; 2.Central nervous system or leptomeningeal lymphoma; 3.Histologically confirmed diagnosis of grade 3b follicular lymphoma or known histological transformation of diffuse large B-cell lymphoma; 4.History of allogeneic bone marrow progenitor cells or organ transplantation; 5.Clinically significant active infection including hepatitis B(HBV),hepatitis C (HCV).Active hepatitis B is defined as: hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)positive,and HBV DNA >= 2000IU/ml(equivalent to 10^4copies/ml),(hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg) positive, HBV DNA 10mg per day (or equivalent) within 7 days prior to enrollment, with the following exceptions: use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids, and short-term use of corticosteroids for prophylaxis, such as contrast media; 12.The researchers believe that previous or ongoing major clinical diseases,surgical history,physical condition,electrocardiogram or laboratory abnormalities may affect the safety of subjects,change the absorption,distribution,metabolism or excretion of research drugs,or affect the evaluation of the results of the study; 13.Major surgery requiring general anesthesia within 4 weeks before enrollment; Surgery requiring local anesthesia/epidural anesthesia and the patient has not yet recovered within 2 weeks prior to enrollment (except bone marrow biopsy or local lymphoid tissue biopsy); 14.Patients with uncontrolled active infection; 15.At rest, the mean corrected QT interval (QTc) > 450 msec (male) or > 470 msec (female) in 3 times of electrocardiogram (ECG) examination (it is only necessary to retest and take the mean corrected value
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;TTR;TTP;PFS;OS; | — |
Countries
China
Contacts
Public ContactQian Changgeng
Outcome results
None listed