Eradication of minimal residual disease (MRD) in chronic lymphocytic leukaemia (CLL) with alemtuzumab: a Phase II study

ISRCTN ISRCTN23153249
DOI https://doi.org/10.1186/ISRCTN23153249
EudraCT/CTIS number 2006-000053-22
ClinicalTrials.gov number NCT00458523
Secondary identifying numbers UKCLL07
Submission date
06/01/2006
Registration date
20/01/2006
Last edited
29/03/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-alemtuzumab-after-chemotherapy-for-chronic-lymphocytic-leukaemia-cll207-mrd-eradication-study

Contact information

Dr Peter Hillmen
Scientific

Department of Haematology
Brotherton Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

Phone +44 (0)113 392 3766
Email peter.hillmen@nhs.net

Study information

Study designMulti-centre open-label single-arm study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleEradication of minimal residual disease (MRD) in chronic lymphocytic leukaemia (CLL) with alemtuzumab: a Phase II study
Study acronymUKCLL07
Study objectives1. 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedChronic lymphocytic leukaemia (CLL)
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Alemtuzumab
Primary outcome measure1. 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. Safety of alemtuzumab in the MRD positive setting
Secondary outcome measures1. Clinical response to alemtuzumab therapy by National Cancer Institute (NCI) Criteria
2. Overall survival
3. Pharmacokinetic profile of alemtuzumab in the MRD setting
4. 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. Time to MRD relapse
2. Effect of alemtuzumab used in a consolidation/maintenance approach on the expression of CD52 on CLL cells
Overall study start date01/03/2006
Completion date29/02/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants54
Total final enrolment47
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/03/2006
Date of final enrolment29/02/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Sponsor information

Leeds Teaching Hospitals NHS Trust (UK)
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/00v4dac24

Funders

Funder type

Industry

Schering Health Care Ltd (funding reference no. UKCLL07)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2017 Yes No
Plain English results 10/07/2017 29/03/2022 No Yes

Editorial Notes

29/03/2022: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
19/03/2020: EudraCT number added.
26/06/2017: Publication reference added.