Clinical Trial Results:
CLARET: CLL Levels following Alemtuzumab in Responders to Early Therapy: A randomised, phase III trial to assess alemtuzumab consolidation therapy in patients with chronic lymphocytic leukaemia (CLL) who have responded to previous therapy.

Trial information Top of page
Trial identification
Sponsor protocol code	HM07/8281
Additional study identifiers
ISRCTN number	ISRCTN63375144
US NCT number	-
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	University of Leeds
Sponsor organisation address	Worsley Building, Leeds, United Kingdom, LS2 9JT
Public contact	Clare Skinner, University of Leeds, c.e.skinner@leeds.ac.uk
Scientific contact	Clare Skinner, University of Leeds, c.e.skinner@leeds.ac.uk
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Results analysis stage
Analysis stage	Interim
Date of interim/final analysis	18 Sep 2012
Is this the analysis of the primary completion data?	No
Global end of trial reached?	No
General information about the trial
Main objective of the trial	The principal research objective is to compare consolidation therapy with alemtuzumab against no consolidation therapy with respect to progression free survival.
Protection of trial subjects	N/A
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	18 Sep 2012
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	No
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	United Kingdom: 99999
Worldwide total number of subjects	99999
EEA total number of subjects	99999
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	99999
From 65 to 84 years	0
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	Trial was withdrawn before opening, so no patients were recruited to the trial.
Pre-assignment
Screening details	N/A
Period 1
Period 1 title	Main Trial Period (overall period)
Is this the baseline period?	Yes
Allocation method	Randomised - controlled
Blinding used	Not blinded
Blinding implementation details	N/A
Arms
Arm title	consolidation therapy with alemtuzumab
Arm description	-
Arm type	Experimental
Investigational medicinal product name	alemtuzumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Subcutaneous use
Dosage and administration details	participants were to receive alemtuzumab injections given under the skin (subcutaneously) 3 times a week for 6 weeks
Number of subjects in period 1 consolidation therapy with alemtuzumab Started 99999 Completed 99999

Subject disposition Top of page

Baseline characteristics Top of page
Baseline characteristics reporting groups
Reporting group title	Main Trial Period
Reporting group description	-
Reporting group values Main Trial Period Total Number of subjects 99999 99999 Age categorical Units: Subjects     In utero 0 0     Preterm newborn infants (gestational age < 37 wks) 0 0     Newborns (0-27 days) 0 0     Infants and toddlers (28 days-23 months) 0 0     Children (2-11 years) 0 0     Adolescents (12-17 years) 0 0     Adults (18-64 years) 99999 99999     From 65-84 years 0 0     85 years and over 0 0 Gender categorical Units: Subjects     Female 99999 99999     Male 0 0

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	consolidation therapy with alemtuzumab
Reporting group description	-

End points Top of page

Primary: progression-free survival of alemtuzumab patients Top of page
End point title	progression-free survival of alemtuzumab patients [1]
End point description	this trial was discontinued with no participants enrolled in the trial.
End point type	Primary
End point timeframe	this trial was discontinued with no participants enrolled in the trial.
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: this trial was discontinued with no participants enrolled in the trial.
End point values consolidation therapy with alemtuzumab Number of subjects analysed 0 [2] Units: yes/no
Notes [2] - this trial was discontinued with no participants enrolled in the trial.
No statistical analyses for this end point

Primary: progression-free survival of alemtuzumab patients Top of page

Adverse events Top of page
Adverse events information [1]
Timeframe for reporting adverse events	n/a- trial never opened to recruitment
Assessment type	Systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	1
Frequency threshold for reporting non-serious adverse events: 0%
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: this trial was discontinued with no participants enrolled in the trial.

Adverse events Top of page

More information Top of page
Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? No
Interruptions (globally)
Were there any global interruptions to the trial? No
Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
this trial was discontinued with no participants enrolled in the trial.

More information Top of page