The value of autografting younger patients with high risk chronic lymphocytic leukaemia (CLL). A randomised phase III intergroup trial

ISRCTN	ISRCTN69559570
DOI	https://doi.org/10.1186/ISRCTN69559570
Secondary identifying numbers	G0001160

Submission date: 02/05/2001
Registration date: 02/05/2001
Last edited: 26/10/2022

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-the-timing-of-transplants-using-a-patients-own-stem-cells-for-chronic-lymphocytic-leukaemia

Contact information

Dr DW Milligan
Scientific

Department of Haematology
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom

Phone	+44 (0)121 424 3699
Email	d.w.milligan@bham.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The value of autografting younger patients with high risk chronic lymphocytic leukaemia (CLL). A randomised phase III intergroup trial
Study acronym	MRC CLL5
Study hypothesis	This is a prospective randomised phase III trial designed to determine the outcome of autologous SCT compared to no further treatment at present in patients with high risk CLL who have reached a complete remission (CR), a very good partial remission (VGPR) or a nodular partial remission (NPR) after first or second line therapy. The MRC CLL5 protocol is avaialble on http://www.ebmt.org/5WorkingParties/CLWP/CLL5/MRC_CLL5_protocol.pdf
Ethics approval(s)	Not provided at time of registration
Condition	Leukaemia
Intervention	In this trial, younger patients with chronic lymphocytic leukaemia who are thought to be medically fit for autologous transplantation will be treated to maximal response with standard chemotherapy. Patients will then be randomised to undergo stem cell mobilisation followed by a cyclophosphamide/total body irradiation conditioned autograft. Purging of the stem cell product is optional. Those patients not randomised to have an autograft will have the option of stem cell storage to be used at a later date.
Intervention type	Other
Primary outcome measure	Primary endpoints: 1. Progression free survival from randomisation 2. Overall survival from randomisation
Secondary outcome measures	Secondary endpoints: 1. Time to disease requiring therapy from time of remission 2. Quality of life 3. Feasibility of first line versus late stem cell transplant 4. Feasibility of peripheral blood mobilisation
Overall study start date	17/01/2002
Overall study end date	16/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	Total 270 - UK anticipated to contribute approximately 125 patients
Total final enrolment	223
Participant inclusion criteria	1. B CLL CD5+/CD23+ 2. There is no upper age limit but patients must be judged physically able to withstand high-dose chemotherapy and the suitability of this treatment may be discussed with the Transplant Centre 3. Binet stage (at initiation of first line treatment) B, C, or progressive A 4. Complete Remission (CR) or Very Good Partial Remission (VGPR) or Nodular Partial Remission (NPR) assessed by bone marrow biopsy after first or second line treatment 5. Written informed consent
Participant exclusion criteria	1. Age less than 18 2. WHO Performance status less than 2 3. Any T-cell leukaemia, NHL, Richter syndrome, mantle cell lymphoma, PLL 4. HIV seropositivity. 5. Inadequate renal or liver function, i.e. creatinine and bilirubin less than 1.5 times the upper limit of normal 6. Severe heart failure, requiring diuretics or ejection fraction of less than 50% 7. Severe concomitant neurological or psychiatric disease 8. Pregnancy/lactation 9. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions should be discussed with the patient before registration in the trial. 10. Patients will be excluded if an allograft is planned
Recruitment start date	17/01/2002
Recruitment end date	16/01/2008

Locations

Countries of recruitment

England
France
Germany
Switzerland
United Kingdom

Study participating centre

Department of Haematology

Birmingham
B9 5SS
United Kingdom

Sponsor information

Heart of England NHS Foundation Trust (UK)
Hospital/treatment centre

Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
England
United Kingdom

Email	not@provided.com
Website	http://www.heartofengland.nhs.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

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	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/02/2011		Yes	No
Plain English results			26/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.