|
ISRCTN
|
ISRCTN53369512
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Medical Research Council/ European Blood and Marrow Transplant Prospective Randomised Trial of Autograft in Chronic Myeloid Leukaemia (CML)
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
MRC CML 2000 (IVa)
|
|
Study hypothesis
|
Not provided at time of registration.
|
|
Ethics approval
|
Not provided at time of registration.
|
|
Study design
|
Randomised controlled trial.
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Leukaemia (chronic)
|
|
Participants - inclusion criteria
|
1. Newly diagnosed Ph-positive and/or breakpoint cluster region (BCR)-abelson (ABL) positive CML
2. Aged 15-65
3 .Chronic phase disease
4. No contraindication to the collection of peripheral blood progenitor cells before commencing treatment
5. No major organ impairment
6. No pregnancy
|
|
Participants - exclusion criteria
|
Not provided at time of registration.
|
|
Anticipated start date
|
01/10/1996
|
|
Anticipated end date
|
30/10/2001
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration.
|
|
Interventions
|
Two Arms:
1. Control: Interferon (IFN) Starting dose 3 x 10(6) units x 3/week escalating to 5 x 10(6) units/m(2) daily. Adjusted to maintain leukocyte count 2-4 x 10(9)/l. Use of hydroxyurea and/or ara-c optional.
2. Investigational: Mobilised or straight autograft, followed by IFN (+/- Ara-c).
|
|
Primary outcome measure(s)
|
Not provided at time of registration.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration.
|
|
Sources of funding
|
1. European Bone Marrow Transplantation Group
2. Medical Research Council (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
-
-
|
|
Address
|
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0) 20 7670 4723
|
|
Fax
|
+44 (0) 20 7670 4818
|
|
Email
|
register@ctu.mrc.ac.uk
|
|
Sponsor
|
Medical Research Council (MRC) (UK)
|
|
Address
|
20 Park Crescent
|
|
City/town
|
London
|
|
Zip/Postcode
|
W1B 1AL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7636 5422
|
|
Fax
|
+44 (0)20 7436 6179
|
|
Email
|
clinical.trial@headoffice.mrc.ac.uk
|
|
Sponsor website:
|
http://www.mrc.ac.uk
|
|
Date applied
|
19/08/2002
|
|
Last edited
|
10/09/2007
|
|
Date ISRCTN assigned
|
19/08/2002
|
