Evaluation of the Safety and Efficacy of the Association of Ibrutinib and Daratumumab in Relapsed/Refractory Chronic Lymphocytic Leukemia With p53 Dysfunction

Summary

Participation Requirements

Description

This study will take place in several periods and phases of treatment: Observational period of selection of 28 days maximum Treatment period constituted: a first phase of treatment with ibrutinib alone (28 days): pre-phase, a formal protocol phase during which the two study drugs (ibrutinib and dara...

This study will take place in several periods and phases of treatment: Observational period of selection of 28 days maximum Treatment period constituted: a first phase of treatment with ibrutinib alone (28 days): pre-phase, a formal protocol phase during which the two study drugs (ibrutinib and daratumumab) will be used together until progression of the disease or intolerance to treatment. 2-year follow-up period that will begin after protocol processing has been stopped. Selection period (before starting treatment): exams performing to verify patients' eligibility. Collection of the medical history, Clinical examination with measurement of height and weight, vital signs (temperature, pulse / heart rate, blood pressure), Conventional blood tests to check all the functions of the body such as kidney, liver, etc Viral serologies (Human Immunodeficiency Virus (HIV) and hepatitis B and C) (10 ml). Blood Pregnancy Test for women who may have children, Specific blood tests to evaluate the disease and in particular to characterize the cells of LLC (mutational profile, search for chromosomal abnormalities and analysis of residual disease rate to have a reference point before the start of treatment will be made on leukemic cells), CT scan (thorax, abdomen and pelvis) to accurately search for and evaluate a deep tumor syndrome (lymph nodes, spleen in particular), Urine examination, Cardiological examination with an electrocardiogram (ECG).. Treatment period: the treatment period is divided into successive cycles of 28 days. Before starting ibrutinib and before each daratumumab cycle, a complete clinical examination and blood work will be performed. After 12 months of treatment, an evaluation report will be made with a complete clinical examination, a complete blood test, an urinalysis if necessary, a Computed Tomography (CT) scan, a myelogram and if necessary a marrow biopsy. Regularly after this assessment (every 6 months until the end of the study), a report will be made with clinical examination, complete blood test, ECG, CT scan and if necessary, myelogram possibly associated with a marrow biopsy if justified and not previously carried out. After the end of the protocol treatment (progression of the disease, intolerance of the protocol treatment), a last evaluation will be carried out within 30 days after the last taking of the protocol treatment. This evaluation includes a complete clinical examination, biological tests (complete blood test) and a CT scan. Follow-up period the completed treatment you will then be followed in consultation every 6 months for 2 years to evaluate the duration of the response to treatment and thus meet the objectives of the study.

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