Condition category
Cancer
Date applied
10/08/2009
Date assigned
05/11/2009
Last edited
05/11/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.dcllsg.de

Contact information

Type

Scientific

Primary contact

Prof Peter Dreger

ORCID ID

Contact details

Department of Internal Medicine V
University of Heidelberg
Heidelberg
69120
Germany

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 measures

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

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

http://www.med.uni-heidelberg.de/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes