None listed
Conditions
Interventions
Drug : As single arm study, patients will be treated as follows
- Rituximab : D1 intravenous injection, 375mg/m2
- Lenalidomide : D1~D21 once daily oral administration, 20mg
- Acalabrutinib : D1~D28 twice a day oral administration, 100mg
Patients will be treated e
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age more than 19 years old 2. Diagnosis with aggressive B-cell non-hodgkin lymphoma - diffuse large B-cell lymphoma(germinal center B-cell-like subtype and non- germinal center B-cell-like subtype both : germinal center B-cell-like subtypes shall not be less than 40%(Number: 26) of the total study population(germinal center B-cell-like subtype patients will be limited to a maximum of 26) - Mediastinal large B-cell lymphoma - Transformed follicular lymphoma - Small lymphocytic lymphoma with Richter transformation 3. The previous treatment fails and the last infusion of treatment must be two weeks ahead of the time of enrollment. - Should have received anti-CD20 based chemotherapy previously. - Fail to at least two lines of therapy if patient is candidate for autologous stem cell transplantation - Fail to frontline therapy if patient is ineligible for autologous stem cell transplant 4. Eastern Cooperative Oncology Group performance status 0, 1 or 2 5. A fertile woman with sexual function should conduct two tests of urine human chorionic gonadotropin before administering the investigational product and then start the test for one week each week, and then every four weeks after that, if her menstrual period is irregular, she should be tested. Test of urine human chorionic gonadotropin shall be carried out up to 4weeks after final administration of acalabrutinib, lenalidomide and rituximab. A female of childbearing potential should use two methods of contraception including at least one highly effective contraception method, for four weeks before the first treatment, four weeks after the last administration of acalabrutinib and lenalidomide, and 12 months after the last administration of Rituximab. Sexual active men should use condoms during treatment and for 4weeks after the last administration of investigational product. 6. Capsule swallowing is possible, and is willing and willing to participate in all the assessments and procedures required by this protocol. 7. It may be permitted to understand the objectives and risks of the study and to use its own medical information for the purposes of the study.
Exclusion criteria
Exclusion criteria: 1. Mantle cell lymphoma 2. In case of more than 5 treatments have previously failed (the hematopoietic transplant is determined by one treatment) 3. In case of patients previously treated with allogeneic hematopoietic stem cell transplantation with 6 months 4. In case of patients with active Graft versus host disease requiring treatment 5. In case oral medication is not available 6. If you have previously been treated with Bruton’s Tyrosine Kinase inhibitors and lenalidomide treatment, both drugs have a progression free survival rate of less than 6 months, or if you have a Bruton’s Tyrosine Kinase protein C481S, or PLGC R665W variable 7. In case of other neoplastic disease other than B cell non-Hodgkin lymphoma within 5 years (except for cervical carcinoma, skin squamous cell carcinoma with simple excision) 8. There were clinically significant cardiovascular disorders (uncontrolled arrhythmia, heart failure, cardiac infarction) within 6 months, or there were cardiovascular disorders clinically significant (brain infarction, cerebral hemorrhage) corresponding to the category 3 or 4 of the New York Heart Association Functional Classification of Cardiology 9. Surgical history of gastrointestinal diseases, inflammatory intestinal diseases, intestinal obstruction and intestinal bypasses that are so severe as to impair absorption 10. Human immunodeficiency virus positive or has other uncontrolled active infections 11. In case of active tuberculosis, in case of latent tuberculosis requiring treatment 12. Hepatitis B virus carrier, or if your blood test indicates that you have a positive anti-B hepatitis core antibody immunoglobulin G, you will be positive for the polymerase chain reaction of hepatitis B virus, hepatitis C virus carrier 13. In case of Life-threatening hypersensitivity or anaphylaxis disease for the drugs included in this clinical study 14. In case of uncontrolled active bleeding or a history of a condition that tends to bleed 15. In case of uncontrolled autoimmune hemolytic anemia or Idiopathic thrombocytopenic purpura 16. In case of a need to take the prohibited medication (CYP3A4 inhibitor/derived drug), Proton pump inhibitor or warfarin or equivalent vitamin K antagonist specified in the protocol 17. In case of a major operation within the last 28 days, or failure to recover after the operation 18. White blood cell 2 times upper limit of normal , or aspartate aminotransferase, alanine aminotransferase > 3 times upper limit of normal 20. Prothrombin time/ international normalized ratio or activated partial thromboplastin time (in the absence of Lupus anticoagulant) > 2 times upper limit of normal 21. Serum creatinine > 1.5 times upper limit of normal or Creatinine Clearance < 30 mL/min/1.73m2 22. Female who is currently pregnant or breast feeding 23. Currently registered in other therapeutic clinical studies for the treatment of lymphoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response;Complete remission rate;Progression free survival;Overall survival;Comparison of hematologic tumor deoxyribonucleic acid through tumor genetic testing | — |
Countries
Korea, Republic of
Contacts
Public ContactKyungwha Choo
Seoul National University Hospital
Outcome results
None listed