Lymphoma
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. fully understood and voluntarily signed informed consent form for this study; 2. aged >=18 years old; 3. mature B-cell tumor patients who were confirmed by pathology (immunophenotyping) and whose standard treatment was ineffective (disease progression or no remission after treatment) or could not tolerate standard treatment and could not receive or did not have standard treatment (see 2016WHO lymphocyte tumor classification); 4. in the dose expansion period of the second stage, each cohort has the following specific enrollment criteria: Cohort A: chronic lymphoblastic leukemia / small lymphocytic lymphoma; Cohort B: invasive B-cell Lymphoma: diffuse large B-cell Lymphoma, Richter Syndrome and Class 3b Follicular Lymphoma; Cohort C: mantle cell lymphoma; Cohort D: inert B-cell lymphoma [including marginal zone lymphoma, lymphatic plasma cell lymphoma / Fahrenheit macroglobulinemia, follicular lymphoma (grade 1, 2, 3a)]; 5. during the dose expansion phase, subjects must have measurable lesions; 6. ECOG physical strength score 0 or 1; 7. the expected survival time judged by the researchers to be more than 24 weeks; 8 fertile male or female patients must agree to use effective contraceptive methods during the study period and within 90 days of the last study medication, such as double barrier contraceptives, condoms, oral or injected contraceptives, IUDs, etc. Postmenopausal women (> 45 years old and menopause for more than one year) and surgical sterilization are not subject to this condition.
Exclusion criteria
Exclusion criteria: 1. primary central nervous system lymphoma confirmed by pathology (immunophenotype); 2. the following laboratory abnormalities: (1) Absolute neutrophil count (ANC) 2.5 ULN when the liver was not invaded by lymphoma, and ALT or AST >5 ULN when the liver was invaded by lymphoma; 5. the serum amylase or lipase >1 ULN.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| spectral CT parameters; | — |
Countries
China
Contacts
Public ContactLi Yonggang
The First Affiliated Hospital of Soochow University
Outcome results
None listed