Mini-allografting to complement treatment with glivec (Imatinib - formerly known as STI571) to eradicate minimal residual disease (MRD) in chronic myeloid leukaemia (CML) patients aged 65 years and under with matched sibling donors
| ISRCTN | ISRCTN86187144 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86187144 |
| Protocol serial number | N0436130285 |
| Sponsor | Department of Health |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 26/04/2018
- 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 G M Smith
Scientific
Scientific
Haematological Oncology Department
D Floor, Brotherton Wing
Leeds Teaching Hospitals NHS Trust
Great George Street
Leeds
LS1 3EX
United Kingdom
| Phone | +44 (0)113 392 5153 |
|---|---|
| graeme.smith@leedsth.nhs.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 | Mini-allografting to complement treatment with glivec (Imatinib - formerly known as STI571) to eradicate minimal residual disease (MRD) in chronic myeloid leukaemia (CML) patients aged 65 years and under with matched sibling donors: a randomised controlled trial |
| Study objectives | To develop a novel clinical immune-therapeutic strategy for CML patients aged 65 and under, found to have suitable matched sibling allogeneic donors, and following remission induction with Glivec. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Chronic myeloid leukaemia |
| Intervention | Patients will be given imatinib for 6 - 12 months with dose increases to 600 mg for poor response. Reduced intensity allograft with peripheral blood stem cells (PBSC) after fludarabine, melphelan and campath conditioning will then take place. If the patient is less than 55 years and there is no complete cytogenetic response (CCR) by the end of 12 months of imatinib despite the dose increase to 600 mg, and if the patient is fit and well, there is an option for total body irradiation (TBI) and cyclophosphamide followed by bone marrow transplantation (BMT). Stem cell transplantation (SCT) followed by incremental donor lymphocyte infusions (DLI) starting with 5 x 10^5 T cells/kg every 12 weeks from six months after allograft until the patient is in complete molecular remission by quantitative reverse transcription polymerase chain reaction (Q-RT-PCR). If the patient requires anti-leukaemic therapy prior to six months following SCT or if graft versus host disease (GVHD) prevents DLI after six months then there is an option for further imatinib post-SCT. |
| Intervention type | Other |
| Primary outcome measure(s) |
Survival and remission status at six months and one year post-transplant. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 24 |
| Key inclusion criteria | 1. Patients aged 65 years and under 2. A diagnosis of chronic myeloid leukaemia 3. Attending the Haematology Out-patients' clinic 4. Fulfill the eligibility criteria |
| Key exclusion criteria | Does not comply with the above inclusion criteria |
| Date of first enrolment | 30/11/2002 |
| Date of final enrolment | 30/09/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Leeds Teaching Hospitals NHS Trust
Leeds
LS1 3EX
United Kingdom
LS1 3EX
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 | 15/05/2008 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/04/2018: Publication reference added.
