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 |
| EudraCT/CTIS number | 2008-001669-27 |
| Secondary identifying numbers | CLLX2 |
- 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
Scientific
Department of Internal Medicine V
University of Heidelberg
Heidelberg
69120
Germany
Study information
| Study design | Randomised phase III active controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Can be found at: http://www.dcllsg.de |
| 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 | 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 study start date | 01/01/2010 |
| Completion date | 01/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
69120
Germany
Sponsor information
University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
University/education
University/education
c/o Prof Dr Michael Hallek
Im Neuenheimer Feld 672
Heidelberg
69120
Germany
| Website | http://www.med.uni-heidelberg.de/ |
|---|---|
"ROR" |
https://ror.org/013czdx64 |
Funders
Funder type
Research organisation
German Cooperative Transplant Study Group (GCTSG) (Germany)
No information available
German Chronic Lymphocytic Leukaemia Study Group (GCLLSG) (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
25/06/2020: Added EudraCT number and link to basic results (scientific).
