Phase
Condition
Lymphocytic Leukemia, Chronic
Treatment
Rituximab
Fludarabine
Chlorambucil
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
CLL/SLL must be diagnosed according to the IWCLL NCI-WG Guidelines (2018 edition)and meet at least one of the criteria requiring treatment.
With a measurable disease.
ECOG score 0-2.
QTcF interval: ≤450ms in males, ≤470ms in females.
Adequate bone marrow function independent of growth factor support.
Adequate liver, kidney and coagulation function.
Males and females of childbearing potential, and their partners voluntarily useeffective contraceptive measures throughout the treatment and for at least threemonths after the last dose of the study drug. Male patients must avoid donation fromthe first dose of the study drug to three months after the last dose of the studydrug.
Female patients of childbearing potential have negative serum pregnancy test resultswithin 14 days prior to the first dose of the study drug.
Patients must be able to understand and voluntarily sign an informed consent formapproved by the Ethics Committee (EC) before commencing any screening or studyspecific procedures.
Must be willing and able to complete research procedures and follow-up examinations.
Exclusion
Exclusion Criteria:
Any previous CLL specific treatment.
Failure to fully recover adequately from prior surgical procedures at the discretionof the investigator. Patients who receive a major surgery within 28 days prior tothe first dose of the study drug or who receive a minor surgery (excluding biopsy)within 14 days prior to the initiation of the study.
Presence of significant cardiovascular disease within 6 months prior to study entry.
A history of significant kidney, neurological, psychiatric, pulmonary, endocrine,metabolic, immune, cardiovascular, or liver disease, which will have an adverseeffect on the patient if he/she participates in the study, at the discretion of theinvestigator.
Patients who require warfarin or other anticoagulants or active hemorrhage occurwithin 2 months before study entry.
Known to have hypersensitivity to the drug ingredient or its analogues.
Pregnant or lactating female patients and patients who are expected to becomepregnant during the study period or within 3 months after the last dose.
Patients who have history of other active malignant tumor other than CLL/SLL within 3 years before study entry.
With a malabsorption syndrome or other conditions unsuitable for enteraladministration.
Other clinically significant uncontrolled symptoms.
With primary active autoimmune disease and connective tissue disease.
Any other circumstances or conditions that would, at the discretion of theinvestigator, make the patient unsuitable for the study.
Study Design
Study Description
Connect with a study center
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui 233004
ChinaSite Not Available
Guangdong Provincial People's Hospital
Guangzhou, Guangdong 510080
ChinaSite Not Available
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong 510515
ChinaSite Not Available
Henan Provincial Cancer Hospital
Zhengzhou, Henan 450003
ChinaActive - Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei 430023
ChinaSite Not Available
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin 300020
ChinaActive - Recruiting
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