Assessing how the drug ibrutinib works in Chronic Lymphocytic Leukaeamia.

• Conditions: Chronic Lymphocytic leukaemia; MedDRA version: 14.1Level: LLTClassification code 10009310Term: CLLSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003608-11-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-04
• Last Update Posted: 7 April 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Cohort A (Treatment naive)
•Progressive Stage A, Stage B or Stage C CLL
•CLL requiring therapy by the IWCLL criteria
•ECOG performance status (PS) of 0, 1, or 2
•Life expectancy of at least 6 months
•Age =16
•Age <65 years or =65 years with deletion 17p
•Prepared to undergo the stipulated investigations within the trial (including bone marrow examinations)
•Able to give informed consent

Cohort B (Relapsed/Refractory)
•CLL requiring therapy
•Refractory CLL defined as any of the following:
• Failure to achieve a response (CR or PR by IWCLL Criteria) to a purine analogue alone or in combination with chemotherapy, or:
• Relapse within 6 months of responding to a purine analogue alone or in combination with chemotherapy, or:
• Relapse within 24 months of responding to a fludarabine, cyclophosphamide and rituximab (FCR), or:
• Patients with CLL with deletion of chromosome 17p who have failed at least one previous therapy.
•ECOG performance status (PS) of 0, 1, or 2 (see appendix 6)
•Life expectancy of at least 6 months
•Prepared to undergo the stipulated investigations within the trial (including bone marrow examinations)
•Age = 16
•Able to give informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

Both cohorts A and B
•Unwilling to undergo the protocol assessments including the bone marrow assessments
•Active infection
•Other severe, concurrent (particularly cardiac or pulmonary) diseases or mental disorders that could interfere with their ability to participate in the study
•Use of prior investigational agents within 6 weeks
•Pregnancy or lactation
•Unwilling to use appropriate contraception during and for 12 months following treatment
•CNS involvement with CLL
•Mantle cell lymphoma
•Known HIV positive
•Active or prior Hepatitis B or C
•Active secondary malignancy excluding basal cell carcinoma
•Persisting severe panocytopenia (nNeutrophils <0.5 x109/L) or transfusion dependent anaemia unless due to direct marrow infiltration by CLL (to be confirmed via bone marrow biopsy)
•Active haemolysis (not controlled with Prednisolone at 10 mg or less)
•Patients requiring or who have received anticoagulation treatment with warfarin or vitamin K antagonists within 1 week of the first dose of ibrutinib
•Patients requiring concomitant use of strong CYP3A4/5 inhibitors
•Patients with evidence or history of transformation and/or PLL
Cohort A (Treatment naive)
•Previous treatment for CLL. This does not include steroids.

Cohort B (Relapsed/Refractory)
•Previous treatment with ibrutinib or an alternative inhibitor of B-Cell receptor pathway

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified