Trial of alpha-interferon in chronic myeloid leukaemia and a comparison of busulphan and hydroxyurea for induction and maintenance
| ISRCTN | ISRCTN46123985 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46123985 |
| Protocol serial number | CML IIIB |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | UK Medical Research Council |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 15/11/2019
- 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
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial. |
| Secondary study design | Randomised controlled trial |
| Scientific title | Trial of alpha-interferon in chronic myeloid leukaemia and a comparison of busulphan and hydroxyurea for induction and maintenance |
| Study objectives | Not provided at time of registration. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Leukaemia (chronic) |
| Intervention | There are four treatment arms, clinicians may choose to randomise between only arms 1 and 2, 3 and 4, 2 and 4 or to randomise between all treatment arms. 1. Regimen A: Induction therapy with busulphan followed by maintenance therapy with busulphan plus alpha-interferon. 2. Regimen B: Induction therapy with busulphan followed by maintenance therapy with busulphan only. 3. Regimen C: Induction therapy with hydroxyurea followed by maintenance therapy with hydroxyurea plus alpha-interferon. 4. Regimen D: Induction therapy with hydroxyurea followed by maintenance therapy with hydroxyurea only. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Alpha-Interferon , busulphan , hydroxyurea |
| Primary outcome measure(s) |
Not provided at time of registration. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 01/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target sample size at registration | 587 |
| Total final enrolment | 587 |
| Key inclusion criteria | 1. Aged over 75 years with either Ph positive or Ph negative chronic myeloid leukaemia in chronic phase. Patients over 75 years or patients unwilling to accept alpha-interferon, may be randomised to busulphan or hydroxyurea, but not interferon or no interferon 2. Adequate renal function 3. No severe concurrent hepatic, renal, cardiovascular, organic brain disease or psychiatric illness 4. Patients with established blast cell crisis or extramedullary granulocytic sarcomas are to be excluded 5. Patients with accelerated phase or platelet count below that specified in the protocol are not eligible |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/08/2000 |
| Date of final enrolment | 01/08/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/06/1995 | 15/11/2019 | Yes | No |
Editorial Notes
15/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
