Condition category
Cancer
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
23/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr G M Smith

ORCID ID

Contact details

Haematological Oncology Department
D Floor
Brotherton Wing
Leeds Teaching Hospitals NHS Trust
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 5153
graeme.smith@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436130285

Study information

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Survival and remission status at six months and one year post-transplant.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

30/11/2002

Overall trial end date

30/09/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date

30/11/2002

Recruitment end date

30/09/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Haematological Oncology Department
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes

23/03/2016: No publications found, verifying study status with principal investigator.