CALiBRe: Assessment of the Mechanism of Action of idelalisib (CAL101) in B-cell Receptor Pathway Inhibition in C

Not Applicable

Completed

• Conditions: Topic: Cancer; Subtopic: Haematological Oncology; Disease: Leukaemia(Chronic Lymphocytic Leukaemia); Cancer; Chronic Lymphocytic Leukaemia

• Registration Number: ISRCTN52057158
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-06
• Study Completion: 2017-05-30
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving MRD-negative remission by IWCLL criteria; Timepoint(s): Ongoing