Assessment of the Mechanism of Action of idelalisib (CAL101) in B-cell Receptor Pathway Inhibition in CLL: a non-randomised interventional trial

niversity of Birmingham0 个研究点目标入组 23 人开始时间: 2015年8月6日最近更新: 2023年1月9日

适应症

试验速览

暂无简介。

•Cohort A (treatment naïve)
•1. Progressive stage A, stage B or stage C CLL
•2. CLL requiring therapy by the IWCLL Response criteria
•3. ECOG performance status (PS) of 0,1 or 2
•4. Life expectancy of at least 6 months
•5. Age =18
•6. Prepared to undergo the stipulated investigations within the trial (including bone marrow examinations)
•7. Able to give informed consent
•Cohort B (relapsed/refractory)
•1. CLL patients requiring therapy
•2. Refractory CLL defined as any of the following:
•2.1. Failure to achieve a response (CR or PR by IWCLL criteria) to a purine analogue alone or in combination with chemotherapy, or:
•2.2. Relapse within 6 months of responding to a purine analogue alone or in combination with chemotherapy, or:
•2.3. Relapse at any time after fludarabine, cyclophosphamide and rituximab (FCR) or bendamustine plus rituximab or:
•2.4. Patients with CLL with deletion of chromosome 17p who have failed at least one previous therapy.
•3. ECOG performance status (PS) of 0, 1 or 2
•4. Life expectancy of at least 6 months
•5. Prepared to undergo the stipulated investigations within the trial (including bone marrow examinations)
•6. Age =18
•7. Able to give informed consent

•Both cohorts A and B
•1. Unwilling to undergo the protocol assessments including the bone marrow examinations
•2. Active infection
•3. Other severe, concurrent (particularly cardiac or pulmonary) diseases or mental disorders that could interfere with their ability to participate in the study
•4. Use of prior investigational agents within 6 weeks
•5. Pregnancy or lactation
•6. Unwilling to use appropriate contraception during and for 30 days following treatment
•7. CNS involvement with CLL
•8. Mantle cell lymphoma
•9. Known HIV positive
•10. Active or prior hepatitis B or C
•11. Active secondary malignancy excluding basal cell carcinoma
•12. Persisting severe pancytopenia (neutrophils <0.5 x 109/L) or transfusion dependent anaemia unless due to direct marrow infiltration by CLL (to be confirmed via bone marrow biopsy)
•13. Active haemolysis (not controlled with prednisolone at 20 mg or less)
•14. Hypersensitivity to the active substance or to any of the excipients listed in the SmPC
•Cohort A (treatment naive)
•Previous treatment for CLL. This does not include steroids
•Cohort B (relapsed/refractory)
•Previous treatment with idelalisib or an alternative inhibitor of Bcell receptor pathway

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