KCT0003724
Recruiting
未知
Phase II trial of Acalabrutinib with rituximab and lenalidomide in relapsed/refractory B-cell non-Hodgkin lymphoma
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Seoul National University Hospital
- Enrollment
- 66
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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