Condition category
Cancer
Date applied
02/05/2001
Date assigned
02/05/2001
Last edited
11/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr DW Milligan

ORCID ID

Contact details

Department of Haematology
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
+44 (0)121 424 3699
d.w.milligan@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0001160

Study information

Scientific title

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Phase III

Drug names

Primary outcome measures

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 trial start date

17/01/2002

Overall trial end date

16/01/2008

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Added 09/09/09: Total 270 - UK anticipated to contribute approximately 125 patients

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

France, Germany, Switzerland, United Kingdom

Trial participating centre

Department of Haematology
Birmingham
B9 5SS
United Kingdom

Sponsor information

Organisation

Heart of England NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Government

Website

http://www.heartofengland.nhs.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21106985

Publication citations

  1. Results

    Michallet M, Dreger P, Sutton L, Brand R, Richards S, van Os M, Sobh M, Choquet S, Corront B, Dearden C, Gratwohl A, Herr W, Catovsky D, Hallek M, de Witte T, Niederwieser D, Leporrier M, Milligan D, , Autologous hematopoietic stem cell transplantation in chronic lymphocytic leukemia: results of European intergroup randomized trial comparing autografting versus observation., Blood, 2011, 117, 5, 1516-1521, doi: 10.1182/blood-2010-09-308775.

Additional files

Editorial Notes