Chronic lymphocytic leukaemia (CLL) unrelated and related allogeneic transplantation in very high risk disease for leukaemia eradication trial

ISRCTN	ISRCTN87956640
DOI	https://doi.org/10.1186/ISRCTN87956640
Clinical Trials Information System (CTIS)	2008-001669-27
Protocol serial number	CLLX2
Sponsor	University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
Funders	German Cooperative Transplant Study Group (GCTSG) (Germany), German Chronic Lymphocytic Leukaemia Study Group (GCLLSG) (Germany)

Submission date: 10/08/2009
Registration date: 05/11/2009
Last edited: 25/06/2020

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

Not provided at time of registration

Contact information

Prof Peter Dreger
Scientific

Department of Internal Medicine V
University of Heidelberg
Heidelberg
69120
Germany

Study information

Primary study design	Interventional
Study design	Randomised phase III active controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A phase III study on the value of allogeneic stem cell transplantation in poor-risk chronic lymphocytic leukaemia
Study acronym	CLLX2
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	EFS 2 years after randomisation, in comparison with conventional treatment.
Key secondary outcome measure(s)	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
Completion date	01/03/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	206
Key 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)
Key exclusion criteria	1. Patients unable to withstand RIC allo-SCT 2. Participation in another clinical trial
Date of first enrolment	01/01/2010
Date of final enrolment	01/03/2015

Locations

Countries of recruitment

Austria
Canada
Germany
Switzerland

Study participating centre

Department of Internal Medicine V

Heidelberg
69120
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results			25/06/2020	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/06/2020: Added EudraCT number and link to basic results (scientific).