Condition category
Cancer
Date applied
03/04/2014
Date assigned
03/04/2014
Last edited
18/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mrs Kathryn Paterson

ORCID ID

Contact details

Institute for Cancer Studies
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
k.r.paterson@bham.ac.uk

Additional identifiers

EudraCT number

2012-003608-11

ClinicalTrials.gov number

Protocol/serial number

15429

Study information

Scientific title

IciCLLe: Assessment of the Mechanism of Action of Ibrutinib (PCI-32765) in B-cell Receptor Pathway Inhibition in CLL

Acronym

IciCLLe

Study hypothesis

The aim of this feasibility study is to confirm the mechanism of action of Ibrutinib. Results will then inform the design of a randomized phase II/III trial using response as the primary outcome measure to determine whether Ibrutinib shows sufficient evidence of activity in these cohorts of patients.

Ethics approval

14/YH/0034; First MREC approval date 20/02/2014

Study design

Non-randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Cancer; Subtopic: Haematological Oncology; Disease: Leukaemia (chronic)

Intervention

Ibrutinib, B-Cell receptor pathway inhibitor; Follow Up Length: 60 month(s); Study Entry : Registration only

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Assess the impact on Ibrutinib on: o CLL cell levels as a percentage of total leucocytes in the b; Timepoint(s): Baseline, Day1, Week 1, Week 2, month 1, Month 2, Month 6, month 9, Month 12.

Secondary outcome measures

1. One and two year progression free survival for relapsed/refractory and treatment naïve patients define; Timepoint(s): 1 and 2 years
2. Two and five year overall survival for relapsed/refractory and treatment naïve patients, defined as the; Timepoint(s): 1 and 5 years
3. Best disease response: Complete Remission (CR); Complete Remission with incomplete marrow recovery; Timepoint(s): Week 1, week 2, Month 1, Month 2, Month 6.
4. Biological response (complete, partial or nodal) at 1, 6 and 12 months, assessed according to the; Timepoint(s): 1, 6, 12 months

Overall trial start date

24/04/2014

Overall trial end date

01/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Cohort A (Treatment naive)
1. Progressive Stage A, Stage B or Stage C CLL
2. CLL requiring therapy by the IWCLL 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 requiring therapy
2. Refractory CLL defined as any of the following:
3. Failure to achieve a response (CR or PR by IWCLL Criteria) to a purine analogue alone or in combination with chemotherapy, or:
4. Relapse within 6 months of responding to a purine analogue alone or in combination with chemotherapy, or:
5. Relapse within 24 months of responding to a fludarabine, cyclophosphamide and rituximab (FCR), or:
6. Patients with CLL with deletion of chromosome 17p who have failed at least one previous therapy.
7. ECOG performance status (PS) of 0, 1, or 2 (see appendix 6)
8. Life expectancy of at least 6 months
9. Prepared to undergo the stipulated investigations within the trial (including bone marrow examinations)
10. Age = 18
11. Able to give informed consent
Target Gender: Male & Female ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 40; UK Sample Size: 40; Description: 2 cohorts of 20 patients each. Cohort A). Treatment naive. Cohort B). Relapse/refractory

Participant exclusion criteria

Both cohorts A and B
1. Unwilling to undergo the protocol assessments including the bone marrow assessments
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 12 months 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 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)
13. Active haemolysis (not controlled with Prednisolone at 10 mg or less)
14. Patients requiring or who have received anticoagulation treatment with warfarin or vitamin K antagonists within 1 week of the first dose of ibrutinib
15. Patients requiring concomitant use of strong CYP3A4/5 inhibitors
16. Patients with evidence or history of transformation and/or PLL

Cohort A (Treatment naive)
1. Previous treatment for CLL. This does not include steroids.

Cohort B (Relapsed/Refractory)
1. Previous treatment with ibrutinib or an alternative inhibitor of BCell receptor pathway

Recruitment start date

24/04/2014

Recruitment end date

01/04/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute for Cancer Studies
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Cancer Research UK Clinical Trials Unit
Institute for Cancer Studies
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Leukaemia and Lymphoma Research (UK); Grant Codes: 12028

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Pharmacyclics Inc.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes