Follicular lymphoma
Conditions
Interventions
Experimental group:Chidamide, bendamustine, Lenalidomide, etoposide, prednisone +CD20 monoclonal antibody
Sponsors
The Hospital Affiliated of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Identified as recurrent or refractory follicular lymphoma (grade 1, 1, and 3a) using the 2016 World Health Organization (WHO) Classification of Diseases, histopathologically/cytologically *. And the subjects cannot tolerate or are unwilling to accept intense chemotherapy due to age or weakness; In the past, he has received up to three lines of treatment, of which stem cell transplantation is considered the first line. In this study, refractory patients were defined as follows: (1) First-line chemotherapy did not achieve complete response (CR); (2) Recurrence or progression of CR within 24 months after first-line chemotherapy; (3) Disease recurrence after first-line chemotherapy and autologous stem cell transplantation consolidation therapy; (4) PR was not achieved by second-line chemotherapy. Definition of relapse patients in this study: Patients with CR in first - or second-line chemotherapy developed disease recurrence 24 months later. 2. Expected survival > 3 months. 3. Aged >=18 years. 4. ECOG 15mm or extranodal lesion diameter > 10mm) and FDG-PET positive lesions]. 6. All screening period laboratory tests are required by the protocol and must be performed within 14 days prior to inclusion. The values of laboratory tests performed for screening must meet the following criteria: (1) Routine blood examination (no blood transfusion, no G-CSF, no drug correction within 14 days before screening) : Hb>=80g/L; ANC>=1.0x10^9/L; PLT acuity 75 x 10 ^ 9 / L; (2) Biochemical examination: TBIL=50 mL/min (Cockcroft-Gault formula); (3) Coagulation function (unless subjects are receiving anticoagulants and coagulation parameters (PT/INR and APTT) at screening are within the expected range of anticoagulant therapy) : INR <=1.5xULN; Activated partial thrombin time (APTT) <=1.5xULN. 7. The women were not breastfeeding, were not pregnant, and agreed not to become pregnant during the study period and for the subsequent 12 months. The male patients agreed that their partners would not become pregnant during the study period and for 12 months thereafter. 8. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Follicular lymphoma grade 3b or follicular lymphoma with large cell transformation (including grade 1, 2, and 3a); 2. Accompanied by hemophagocytic syndrome; 3. Uncontrolled severe active infections, including active tuberculosis; 4. Known to have central nervous system (CNS), testicular and breast lymphoma; Patients with a large number of pleural effusion; 5. Received any medication of sidarbenamine or lenalidomide within the previous 6 months; Or bendamustine and rituximab (BR) regimen; 6. Previously received allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation; 7. Autologous hematopoietic stem cell transplantation was performed within 6 months prior to the start of treatment; 8. Had major surgery within 28 days before the start of treatment; 9. Administer live vaccine (except attenuated influenza vaccine) within 28 days before starting treatment; 10. Participating in other clinical studies, or planning to start this study treatment less than 4 weeks after the end of the previous clinical study; 11. Patients with serious medical diseases, such as organic heart disease, resulting in clinical symptoms or abnormal heart function (NYHA >=2), history of myocardial infarction within 6 months before screening, ejection fraction < 50% on echocardiography, and severe thromboembolic disease; 12. HIV positive patients; 13. Other malignancies in the past 5 years, excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, and gastrointestinal intramucosal carcinoma after radical treatment; 14. Other systemic antitumor therapies may be administered during the study; 15. Other psychological conditions that prevent patients from participating in the study or signing informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate, CRR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate, ORR;Progression free survival time, PFS;Overall survival time, OS; | — |
Countries
China
Contacts
Public ContactXue Hongwei
The Hospital Affiliated of Qingdao University
Outcome results
None listed