Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CLLX2
Study information
Scientific title
A phase-III study on the value of allogeneic stem cell transplantation in poor-risk chronic lymphocytic leukaemia
Acronym
CLLX2
Study hypothesis
Allogeneic stem cell transplantation (allo-SCT) with reduced-intensity conditioning (RIC) can increase event-free survival (EFS) 2 years after randomisation from 40% to 70% (high-risk CLL) and from 10% to 40% (very high-risk CLL), respectively, in comparison with conventional treatment.
Ethics approval
Not provided at time of registration
Study design
Randomised phase III active controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Can be found at: http://www.dcllsg.de
Condition
High-risk and very high-risk chronic lymphocytic leukaemia (CLL)
Intervention
Stratum 1: Patients achieving complete remission (CR)/partial remission (PR) after three cycles of salvage and having an HLA-identical donor at 3 months landmark (LM) are randomised 1:1 to RIC allo-SCT (experimental intervention) or to three additional cycles of salvage (control intervention).
Stratum 2: All eligible patients will undergo biological randomisation at the 3-month LM: Patients with an HLA-compatible donor available 3 month after registration will proceed to RIC allo-SCT (donor arm-experimental intervention). Patient without donor will receive non-transplant consolidation treatment or observation (no donor arm - control intervention).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
EFS 2 years after randomisation, in comparison with conventional treatment.
Secondary outcome measures
Measured at patient recruitment and then at 12 and 24 months after randomisation:
1. 5-year overall survival (OS) from randomisation; 5-year OS from registration (Stratum 2 only)
2. Clinical response
3. Safety from any cause
4. Non-relapse mortality
5. Morbidity
6. Chronic graft-versus-host disease
7. Quality of life, measured using the EORTC questionnaire
Overall trial start date
01/01/2010
Overall trial end date
01/03/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 - 65 years, either sex
2. World Health Organization performance status (WHO PS) grade 0 - 1
3. Active and measurable high risk CLL (Stratum 1) or very high risk CLL (Stratum 2)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
206
Participant exclusion criteria
1. Patients unable to withstand RIC allo-SCT
2. Participation in another clinical trial
Recruitment start date
01/01/2010
Recruitment end date
01/03/2015
Locations
Countries of recruitment
Austria, Canada, Germany, Switzerland
Trial participating centre
Department of Internal Medicine V
Heidelberg
69120
Germany
Sponsor information
Organisation
University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
Sponsor details
c/o Prof Dr Michael Hallek
Im Neuenheimer Feld 672
Heidelberg
69120
Germany
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
German Cooperative Transplant Study Group (GCTSG) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
German Chronic Lymphocytic Leukaemia Study Group (GCLLSG) (Germany)
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
Basic results (scientific)
Publication list