Condition category
Cancer
Date applied
06/01/2006
Date assigned
20/01/2006
Last edited
25/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Peter Hillmen

ORCID ID

Contact details

Department of Haematology
Brotherton Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 3766
peter.hillmen@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00458523

Protocol/serial number

UKCLL07

Study information

Scientific title

Eradication of Minimal Residual Disease (MRD) in Chronic Lymphocytic Leukaemia (CLL) with Alemtuzumab: a Phase II Study

Acronym

UKCLL07

Study hypothesis

1. Is alemtuzumab effective and safe at treating patients with CLL whose disease is present at a low level following conventional treatments?
2. There will also be an investigation where MRD negative patients are monitored and retreated when necessary.

Ethics approval

Not provided at time of registration

Study design

Multi-centre, open-label, single-arm study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic lymphocytic leukaemia (CLL)

Intervention

Patients who have previously achieved a minimal residual disease (MRD) negative remission and have relapsed at a molecular level, or who have a low level of MRD following conventional therapy will receive treatment for a minimum of 6 weeks (3 times per week) and a maximum of 12 weeks. Patients who have achieved an MRD negative state by conventional therapy may register for the study but will not be treated with alemtuzumab until CLL becomes detectable again.

Intervention type

Drug

Phase

Phase II

Drug names

Alemtuzumab

Primary outcome measures

1. To determine the rate of achieving MRD negativity in patients with low levels of MRD following conventional therapy or who relapse at an MRD level after a previous MRD negative remission
2. To assess the safety of alemtuzumab in the MRD positive setting

Secondary outcome measures

1. To determine the clinical response to alemtuzumab therapy (by National Cancer Institute [NCI] Criteria)
2. To evaluate the overall survival
3. To investigate the pharmacokinetic profile of alemtuzumab in the MRD setting
4. To investigate the safety and efficacy of repeated dosing as required to achieve sustained MRD negativity

Outcome of additional Monitoring Investigation (patients who are MRD negative at registration):
1. To evaluate the time to MRD relapse

2. To assess the effect of alemtuzumab used in a consolidation/maintenance approach on the expression of CD52 on CLL cells

Overall trial start date

01/03/2006

Overall trial end date

29/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. At least 18 years old
2. Written informed consent
3. Previous confirmation of B-cell CLL with a characteristic immunophenotype on peripheral blood flow cytometry
4. Creatinine and bilirubin <2 x upper limit of normal unless secondary to direct infiltration of the liver by CLL or haemolysis
5. Must have achieved a complete remission or good partial remission after therapy for CLL
6. At least six months since completing last therapy for CLL
7. Have detectable MRD, as shown by peripheral blood or bone marrow involvement or have attained an MRD negative remission. The latter group is eligible for registration and three-monthly monitoring for MRD relapse

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

54

Participant exclusion criteria

1. Lymph nodes of 2 cm or greater in maximum diameter
2. Known Human Immunodeficiency Virus (HIV) positive
3. Active infection
4. Past history of anaphylaxis following exposure to rat or mouse derived Commonly Deleted Region (CDR)-grafted humanised monoclonal antibodies
5. Use of prior investigational agents within six weeks
6. Pregnancy or lactation
7. Central Nervous System (CNS) involvement with CLL
8. Mantle cell lymphoma
9. Other severe, concurrent diseases or mental disorders
10. Active secondary malignancy
11. Persisting severe pancytopenia due to previous therapy rather than disease (neutrophils <0.5 x 109/l or platelets <50 x 109/l)
12. Patients previously treated with allogeneic Stem Cell Transplantation (SCT)
13. Patients who previously failed alemtuzumab therapy

Recruitment start date

01/03/2006

Recruitment end date

29/02/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Haematology
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Leeds Teaching Hospitals NHS Trust (UK)

Sponsor details

Department of Research and Development
Leeds Teaching Hospitals NHS Trust
6th Floor Wellcome Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

Schering Health Care Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Brow

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Burgess Hill

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

West Sussex

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

RH15 9NE

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

(funding reference no. UKCLL07)

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

25/02/2016: No publications found, verifying study status with principal investigator