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
Protocol serial number	G0001160
Sponsor	Heart of England NHS Foundation Trust (UK)
Funder	Medical Research Council (MRC) (UK)

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 of protocol

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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
Health condition(s) or problem(s) studied	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(s)	Primary endpoints: 1. Progression free survival from randomisation 2. Overall survival from randomisation
Key secondary outcome measure(s)	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
Completion date	16/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	270
Total final enrolment	223
Key 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
Key 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
Date of first enrolment	17/01/2002
Date of final enrolment	16/01/2008

Locations

Countries of recruitment

United Kingdom
England
France
Germany
Switzerland

Study participating centre

Department of Haematology

Birmingham
B9 5SS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
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.