Condition category
Cancer
Date applied
22/08/2008
Date assigned
30/09/2008
Last edited
14/03/2016
Prospective/Retrospective
Prospectively 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

Prof Charles Craddock

ORCID ID

Contact details

Centre for Clinical Haematology
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom
-
charles.craddock@uhb.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RG_07-202

Study information

Scientific title

Phase I/II study of the adjunctive use of nilotinib in patients undergoing reduced intensity allogeneic transplantation for imatinib resistant or intolerant chronic myeloid leukaemia

Acronym

TRICE

Study hypothesis

Disease relapse is the major cause of treatment failure after allogeneic transplantation using reduced intensity conditioned (RIC) regimens in patients with chronic myeloid leukaemia (CML) and therefore strategies which reduce the risk of disease relapse are required. Although there has been interest in the use of prophylactic donor lymphocyte infusions (DLI) to reduce the risk of relapse, their use is associated with a significant risk of severe graft-versus-host disease (GvHD) when administered early post-transplant. Nilotinib has potent anti-leukaemic activity in patients who are resistant or intolerant to imatinib and this study aims to examine whether its administration post-transplant can modify the kinetics of disease relapse after a RIC allograft thereby eliminating or postponing the requirement for DLI.

Ethics approval

Cambridgeshire 1 Research Ethics Committee, 24/10/2008, ref: 08/H0304/91

Study design

Phase I/II multicentre single-arm open-label non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Chronic myeloid leukaemia (CML)

Intervention

Nilotinib will be commenced on day +35 post-transplant. Nilotinib will be commenced at a dose of 200 mg daily (orally) for two weeks and if this is tolerated, it will be increased to 200 mg twice daily for a further two weeks. Patients will further escalate their dose to 400 mg twice daily (bd) until 12 months post-transplant. Nilotinib will then be discontinued. The total follow-up period is 13 months.

Intervention type

Drug

Phase

Phase I/II

Drug names

Nilotinib

Primary outcome measures

Safety and tolerability of nilotinib therapy. Adverse events and therapy-related side effects will be monitored continuously during nilotinib treatment and until 28 days after the last dose.

Secondary outcome measures

1. Relapse rate, assessed at 12 months post-transplant
2. Survival, assessed annually until 3 years post-transplant

Overall trial start date

03/11/2008

Overall trial end date

29/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. BCR/ABL positive CML in first chronic phase
2. Resistant or intolerant to imatinib mesylate
3. Aged greater than 18 years, either sex
4. Patients with a human leukocyte antigen (HLA) identical sibling donor or a suitable matched unrelated donor
5. Patients considered fit for transplantation
6. Patients must be able to swallow capsules
7. Liver function less than 2.5 upper limit of normal
8. In patients with magnesium and potassium levels below the lower limit of normal (LLN), every attempt should be made to normalise levels
9. All men and women of child bearing potential must agree to practice effective contraception during the entire study period
10. CML patients who have been treated with an investigational tyrosine kinase inhibitor who otherwise meet the definition or imatinib-resistance or intolerance are eligible
11. Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
12. Be willing and able to comply with the protocol for the duration of the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15 patients

Participant exclusion criteria

1. Patients with an allergy to fludarabine, busulphan, campath or nilotinib
2. BCR/ABL negative CML
3. Pregnant or lactating women
4. Patients with organ allografts
5. Impaired cardiac function
6. Patients with any other condition, which in the Investigator's opinion would not make the patient a good candidate for the clinical trial

Recruitment start date

03/11/2008

Recruitment end date

29/10/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Research and Commercial Services
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
charles.craddock@uhb.nhs.uk

Sponsor type

University/education

Website

http://www.rcs.bham.ac.uk

Funders

Funder type

Industry

Funder name

Novartis Pharmaceuticals UK Limited

Alternative name(s)

Novartis UK

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

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

Publication citations

Additional files

Editorial Notes

14/03/2016: No publications found, verifying study status with principal investigator