Clinical trial for patients with TKI resistant chronic myeloid leukaemia in chronic or accelerated phase
| ISRCTN | ISRCTN68270067 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68270067 |
| EudraCT/CTIS number | 2018-001843-29 |
| Secondary identifying numbers | TASTER2018 |
- Submission date
- 22/01/2019
- Registration date
- 13/02/2019
- Last edited
- 06/11/2023
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Contact information
Mrs Karen Carty
Public
Public
Cancer Research UK Clinical Trials Unit
1053 Great Western Road
Glasgow
G12 OYN
United Kingdom
| Phone | +44 (0)141 301 7197 |
|---|---|
| karen.carty@glasgow.ac.uk |
Study information
| Study design | Adaptive randomised screening phase II design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format |
| Scientific title | An umbrella adaptive randomised multi–arm screening phase II trial for patients with 2nd/3rd generation TKI resistant chronic myeloid leukaemia |
| Study acronym | TASTER (TArgeting STEm cell Resistance) |
| Study hypothesis | The trial will investigate whether a novel agent can be combined with TKI to improve treatment response, as measured by BCR-ABL1IS transcript levels in chronic and accelerated phase chronic myeloid leukaemia. |
| Ethics approval(s) | Approved 28/05/2019, London – City & East Research Ethics Committee (Bristol Research Ethics Committee Centre, Whitefriars, Level 3, Block B, Lewins Mead, Bristol, BS1 2NT, UK; Tel: +44 (0)207 104 8171; Email: nrescommittee.london-cityandeast@nhs.net), ref: 19/LO/0529 |
| Condition | Chronic myeloid leukaemia |
| Intervention | The trial will commence initially with a control arm (TKI) and 2 experimental arms (TKI + EZH2i [Tazemetostat-EPZ-6438], TKI + MDM2i [Idasanutlin –RO5503781]). The number of experimental arms will change over time as further novel agents are introduced to the trial via amendment. Patients will be randomised 1:1:1 to a control arm and 2 experimental arms. Arm A: TKI monotherapy (control arm): Patients will continue on the same TKI they have been taking for previous 3 (accelerated phase) and 6 (chronic phase) months prior to entering the trial continuously for each cycle e.g. day 1 -28. Authorised TKIs are imatinib, nilotinib, dasatinib, bosutinib and ponatinib. Arm B: EPZ-6438 - Tazemetostat with TKI: Dose level -1 – low dose oral 400 mg BD 28 days continuous Dose level 1 – starting dose oral 600 mg BD 28 days continuous Dose level 2 – escalation dose oral 800 mg BD 28 days continuous Authorised TKIs are imatinib, nilotinib, dasatinib, bosutinib and ponatinib Patients will continue on the same TKI they have been taking for previous 3 (accelerated phase) or 6 (chronic phase) months prior to entering the trial. The TKI will be taken in combination with Tazemetostat. Note the TKI is taken continuously throughout each cycle e.g. days 1-28 Arm C: RO5503781 - Idasanutlin with TKI: Dose level -1 – low dose oral idasanutlin (Spray Dried Powder [SDP] DP formulation) 100 mg OD for days 1-5 of 28 day cycle Dose level 1 – starting dose oral idasanutlin (Spray Dried Powder [SDP] DP formulation) SDP 150 mg OD for days 1-5 of 28 day cycle Dose level 2 – escalation dose oral idasanutlin (Spray Dried Powder [SDP] DP formulation) SDP 200 mg OD for days 1-5 of 28 day cycle Authorised TKIs are imatinib, nilotinib, dasatinib, bosutinib and ponatinib Patients will continue on the same TKI they have been taking for previous 3 (accelerated phase) or 6 (chronic phase) months prior to entering the trial. The TKI will be taken in combination with Idasanutlin. Note the TKI is taken continuously throughout each cycle e.g. days 1-28 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Imatinib, Nilotinib, Dasatinib, Bosutinib, Ponatinib, Tazemetostat, Idasanutlin |
| Primary outcome measure | The proportion of treatment ‘responders’ defined as patients who achieve a > 0.5 log reduction in BCR-ABL1 mRNA levels at any time during 32 weeks of treatment (by 33 weeks from baseline) |
| Secondary outcome measures | 1. Toxicities assessed according to NCI CTCAE V5.0 2. Durability of improvement in BCR-ABL1 mRNA level in responding chronic and accelerated phase CML patients, measured by levels of BCR ABL1 every 3 months from baseline until end of study 3. Rate of haematological improvement measured by standard FBC and manual differential WBC assessed monthly from baseline to 32 weeks 4. Rate of CyR improvement by 32 weeks, measured by standard cytogenetics - metaphase cytogenetics on >20 metaphases obtained from WBC in bone marrow 5. Rate of molecular improvement by 32 weeks (BCR-ABL<10%, < 1%, < 0.1%, and , 0.01%), measured by levels of BCR ABL1 assessed every 3 months from baseline until end of study 6. Drug-drug interactions by measuring levels of TKI and novel agents (i.e. PK) at specified timepoints during cycles 1 and 2 on experimental arms of the study 7. Overall patient survival, event-free survival and relapse-free survival will be determined by the time from baseline (randomisation) to each of death, event and relapse. The comparisons between each experimental arm and the control arm will be made using a Cox regression model. Event Free Survival (EFS) will be defined as follows: (Date of event - start date of study medication). For the purposes of the study an ‘event’ will be defined as the first occurrence of one of the following: 7.1. Death from any cause 7.2. Disease progression (as defined below) 7.3. Loss of CHR defined as the appearance of any of the following, confirmed by a second determination ≥ 1 month later: WBC count that rises to > 20.0 x 109/L, platelet count that rises to ≥ 600 x 109/L, appearance of blasts in the peripheral blood 7.4. Increasing WBC count: for patients not achieving a CHR, haematological progression will be defined as a doubling of WBC count at least one month apart with at least the second value >20.0 x 109/L 7.5. Loss of major cytogenetic response (MCR): for patients that were in MCR at study entry; loss of MCR will be defined as an increase in the Ph+ bone marrow cells by at least 30 percentage points (e.g., from 20% to 50%, or from 30% to 60%) confirmed by a second cytogenetic analysis ≥1 month later 8. Time to haematological, cytogenetic and molecular response will be determined by the time from baseline (randomisation) to each of haematological, cytogenetic and molecular response. 9. Time to molecular, cytogenetic or haematological relapse and to progression to accelerated or blast phase and to progression to accelerated or blast phase will be determined by the time from baseline (randomisation) to each of molecular, cytogenetic or haematological relapse, and progression. 10. Quality of life measured using MDASI-CML and EQ5D at baseline, C9 D1, C16 D1 and C20 D1 |
| Overall study start date | 01/04/2018 |
| Overall study end date | 28/02/2025 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 102 |
| Participant inclusion criteria | Inclusion Criteria – Chronic Phase Patients: 1. Patient aged >18 years 2. Patient has given written informed consent to participate in the trial 3. Patients with Ph+, BCR ABL + Chronic Phase CML 4. Prior treatment with at least two 2nd (nilotinib, dasatinib or bosutinib) or 3rd generation (ponatinib) TKI, or imatinib after failure or intolerance to 2nd/3rd generation TKI, on same TKI for period of > 6 months 5. No switch between TKIs within the last 6 months 6. ELN failure defined as BCR-ABL level on IS of >10% and/or Ph >35% at > 6 months of taking 2nd or subsequent line of TKI therapy or >1% and/or Ph >0% by 12 months of taking 2nd or subsequent line of TKI therapy. Patients entering TASTER on imatinib need to meet the above definition for failure of 2nd or subsequent line of TKI therapy and/or be intolerant to 2nd or subsequent line of TKI therapy, and have ELN failure on imatinib 7. Patients with ECOG grade 0 to 2 8. Patients require tohave adequate renal function defined as calculated creatinine clearance > 40ml/min per the Cockcroft and Gault formula (appendix 5) or local institutional standard formula 9. Adequate haematological and biochemical function as indicated below. These measurements must be performed within 7 days prior to randomisation: 9.1. ALT or AST < 2.5 x ULN 9.2. Total Bilirubin < 1.5 x ULN ( for patients with bilirubin >1.5 x ULN, they will require to have conjugated and unconjugated bilirubin checked, if conjugated bilirubin < 1.5 x ULN the patient will be eligible) 9.3. Lipase or amylase < 1.5 x ULN 9.4. Neutrophils > 1.0 x 109/l 9.5. Platelets > 100 x 109/l 9.6. WBC < 50 x 109/l 10. Willingness to comply with scheduled visits, treatment plans and laboratory tests and other trial procedures 11. Ability to swallow oral medications 12. Females of childbearing potential must have a negative pregnancy test within 7 days prior to randomisation and agree to use highly effective contraceptive measures (see section 7.1.8.1) from the time of negative pregnancy test up to 90 days after the last dose of study drug. Non-childbearing potential must be evidenced by fulfilling one of the following criteria at screening: 12.1. Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments 12.2. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation 13. Male patients with partners of child-bearing potential must agree to use highly effective contraceptive measures for the duration of the study and up to 90 days after the last dose of study drug Inclusion Criteria – Accelerated Phase Patients: 1. Patient aged >18 years 2. Patient has given written informed consent to participate in the trial. 3. Patients with Ph+, BCR-ABL + Accelerated Phase CML defined as presence of one of the following: 3.1. Blasts in blood or marrow 15-29%, or blasts plus promyelocytes in blood or marrow >30%, with blasts <30% 3.2. Basophils in blood ≥20% 3.3. Persistent thrombocytopenia (<100x109/L) unrelated to therapy 3.4. Clonal chromosome abnormalities in Ph+ cells (CCA/Ph+), major route, on treatment 4. Treatment with > one 2nd (nilotinib, dasatinib or bosutinib) or 3rd generation (ponatinib) TKI, or imatinib after failure or intolerance to 2nd/3rd generation TKI, on same TKI for period of > 3 months 5. No switch between TKIs within the last 3 months 6. ELN failure in accelerated phase defined as BCR-ABL level on IS of >10% and/or Ph>65% at 3 months or >10% or Ph >35% at > 6 months or >1% and/or Ph >0% by 12 months of taking 2nd or subsequent line of TKI therapy Patients entering TASTER on imatinib need to meet the above definition for failure of 2nd or subsequent line of TKI therapy and/or be intolerant to 2nd or subsequent line of TKI therapy and have ELN failure on imatinib 7. Patients with ECOG grade 0 to 2 8. Patients require to have adequate renal function defined as calculated creatinine clearance > 40ml/min per the Cockcroft and Gault formula (appendix 5) or local institutional standard formula 9. Adequate haematological and biochemical function as indicated below. These measurements must be performed within 7 days prior to randomisation: 9.1. ALT or AST < 2.5 x ULN 9.2. Total Bilirubin < 1.5 x ULN (for patients with bilirubin > 1.5 x ULN they will require to have conjugated and unconjugated bilirubin checked, if conjugated bilirubin < 1.5 x ULN the patient will be eligible) 9.3. Lipase or amylase < 1.5 x ULN 9.4. Neutrophils > 1.0 x 109/l 9.5. Platelets > 100 x 109/l 9.6. WBC < 50 x 109/l 10. Willingness to comply with scheduled visits, treatment plans and laboratory tests and other trial procedures 11. Ability to swallow oral medications 12. Females of childbearing potential must have a negative pregnancy test within 7 days prior to randomisation and agree to use highly effective contraceptive measures (see section 7.1.8.1) from the time of negative pregnancy test up to 90 days after the last dose of study drug. Non-childbearing potential must be evidenced by fulfilling one of the following criteria at screening: 12.1. Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments 12.2. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation 13. Male patients with partners of child-bearing potential must agree to use highly effective contraceptive measures for the duration of the study and up to 90 days after the last dose of study drug |
| Participant exclusion criteria | Exclusion Criteria – Chronic Phase Patients: 1. Pregnant or lactating women 2. Females of child bearing potential or males not willing to use a highly effective method of contraception 3. Patient in planning for allogeneic SCT within 6 months 4. Patients with cardiovascular disease defined as: 4.1. QTc > 450 (males), >470 (females) 4.2. Stage II to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure within the previous 6 months 4.3. Myocardial infarction within the previous 6 months 4.4. Symptomatic cardiac arrhythmia requiring treatment within the previous 6 months 4.5. Grade III or IV fluid retention within the previous 6 months 5. Known BCR-ABL kinase domain mutation expected to be sensitive to an alternative TKI 6. Patients with a history of another malignancy other than non-metastatic basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix; the exception is if patients have been disease-free for at least 5 years, and are deemed by the investigator to be low risk for recurrence of that malignancy. Patients with a history of breast cancer continuing on tamoxifen or an aromatase inhibitor are eligible for the study if they have been disease free for at least 5 years 7. Patients with history of T-cell lymphoblastic lymphoma (T-LBL) or T-cell acute lymphoblastic leukaemia (T –ALL) 8. Patients with thrombocytopenia, neutropenia or anaemia of grade > 3 (per CTCAE version 5.0 criteria) or any prior history of other myeloid malignancies including myelodysplastic syndrome (MDS) 9. Patients taking medications that are known strong CYP3A4 inducers (including St John’s Wort) and strong CYP3A4 inhibitors unless stopped at least 14 days before commencing trial medication. Moderate CYP3A4 inducers and inhibitors should be used with caution 10. Patients taking medications that are known strong CYP2C8 inhibitors and inducers or CYP2C8 substrates unless stopped at least 14 days before commencing trial medications. Moderate CYP2C8 inducers and inhibitors may be used with caution 11. Patients taking medications that are known UGT inhibitors and inducers unless stopped at least 14 days before commencing trial medications 12. Patients taking medications that are OATP1B1 and OATP1B3 substrates with a narrow safety window (or safety concerns) should be stopped at least 14 days before commencing trial medications. Others should be used with caution 13. Patients taking concomitant treatment with medicines listed as prohibited in section 5.3.9 for imatinib, section 5.4.8 nilotinib, section 5.5.8 dasatinib, section 5.6.8 bosutinib or section 5.7.8 ponatinib (as applicable to patient) 14. Patients unable to temporarily interrupt treatment with oral or parental anticoagulants/anti platelet agents (e.g. warfarin, chronic daily treatment with aspirin [>325 mg/day], clopidrogel, dabigatran, apixiban, rivaroxaban, or subcutaneous [SC] anticoagulant prophylaxis) during treatment phase. These agents must be stopped at least 7 days (or 5 half lifes) before commencing trial medications 15. Patients unwilling to remove Seville oranges, grapefruit juice and grapefruits from their diet 16. Patients that have received any systemic anti-cancer therapy (except hydroxycarbamide, anagrelide, low dose arabinosyl-cytarabine (LDAC), steroids, or interferon), surgery or radiotherapy within the 28 days prior to randomisation 17. Treatment with any other investigational agent within 14 days prior to first dose of medication on TASTER trial 18. History of physical or psychiatric disorder that would prevent informed consent and compliance with protocol 19. Patients with acute infections 20. Patients which have had a cerebrovascular accident within 6 months prior to randomisation 21. Patients with active GI conditions (e.g. Grade > 2 graft-versus-host-disease) and uncontrolled irritable bowel disease (i.e. Crohn’s disease, ulcerative colitis, diverticulosis-associated colitis and Behcet’s disease) 22. Patients with any other severe concurrent disease which may increase the risk associated with trial participation or trial treatment 23. Any psychological, familial, sociological or geographical consideration potentially hampering compliance with trial protocol and follow-up schedule 24. Patients known to have a positive Hepatitis B serology 25. Patients with a history of previous therapy with tazemetostat or idasanutlin at any time 26. Patients with a history of previous therapy with EZH2 inhibitor 27. Patients with a known hypersensitivity to imatinib, nilotinib, dasatinib, bosutinib, ponatinib, idasanutlin or tazemetostat or any of their excipients 28. Patients with rare hereditary problems of galactose intolerance or the Lapp lactase deficiency or glucose-galactose malabsorption Exclusion Criteria – Accelerated Phase Patients 1. Pregnant or lactating women 2. Females of child bearing potential or males not willing to use a highly effective method of contraception 3. Patient in planning for allogeneic SCT within 6 months 4. Patients with cardiovascular disease defined as: 4.1. QTc > 450 (males),> 470 (females) 4.2. Stage II to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure within the previous 6 months 4.3. Myocardial infarction within the previous 6 months 4.4. Symptomatic cardiac arrhythmia requiring treatment within the previous 6 months 4.5. Grade III or IV fluid retention within the previous 6 months 5. Known BCR-ABL kinase domain mutation expected to be sensitive to an alternative TKI 6. Patients with a history of another malignancy other than non-metastatic basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix; the exception is if patients have been disease-free for at least 5 years, and are deemed by the investigator to be low risk for recurrence of that malignancy. Patients with a history of breast cancer continuing in tamoxifen or an aromatase inhibitor are eligible for the study if they have been disease free for at least 5 years 7. Patients with history of T-cell lymphoblastic lymphoma (T-LBL) or T-cell acute lymphoblastic leukaemia (T –ALL) 8. Patients with thrombocytopenia, neutropenia or anaemia of grade > 3 (per CTCAE version 5.0 criteria) or any prior history of other myeloid malignancies including myelodysplastic syndrome (MDS) 9. Patients taking medications that are known strong CYP3A4 inducers (including St Johns Wort) and strong CYP3A4 inhibitors unless stopped at least 14 days before commencing trial medication. Moderate CYP3A4 inducers and inhibitors should be used with caution 10. Patients taking medications that are known strong CYP2C8 inhibitors and inducers or CYP2C8 substrates unless stopped at least 14 days before commencing trial medications. Moderate CYP2C8 inducers and inhibitors may be used with caution 11. Patients taking medications that are known UGT inhibitors and inducers unless stopped at least 14 days before commencing trial medications 12. Patients taking medications that are, OATP1B1 and OATP1B3 substrates with a narrow safety window (or safety concerns) should be stopped at least 14 days before commencing trial medications. Others should be used with caution 13. Patients taking concomitant treatment with medicines listed as prohibited in section 5.3.9 for imatinib, section 5.4.8 nilotinib, section 5.5.8 dasatinib, section 5.6.8 bosutinib or section 5.7.8 ponatinib (as applicable to patient) 14. Patients unable to temporarily interrupt treatment with oral or parental anticoagulants/anti platelet agents (e.g. warfarin, chronic daily treatment with aspirin [>325 mg/day], clopidrogel, dabigatran, apixiban, rivaroxaban, or subcutaneous [SC] anticoagulant prophylaxis) during treatment phase. These agents must be stopped at least 7 days (or 5 half lifes) before commencing trial medications 15. Patients unwilling to remove Seville oranges, grapefruit juice and grapefruits from their diet 16. Patients that have received any systemic anti-cancer therapy (except hydroxycarbamide, anagrelide, low dose arabinosyl-cytarabine (LDAC), steroids, or interferon), surgery or radiotherapy within the 28 days prior to randomisation 17. Treatment with any other investigational agent within 14 days prior to first dose of medication on TASTER trial 18. History of physical or psychiatric disorder that would prevent informed consent and compliance with protocol 19. Patients with acute infections 20. Patients which have had a cerebrovascular accident within 6 months prior to randomisation 21. Patients with active GI conditions (e.g. Grade > 2 graft-versus-host-disease) and uncontrolled irritable bowel disease (i.e. Crohn’s disease, ulcerative colitis, diverticulosis-associated colitis, and Behcet’s disease) 22. Patients with any other severe concurrent disease which may increase the risk associated with trial participation or trial treatment 23. Any psychological, familial, sociological or geographical consideration potentially hampering compliance with trial protocol and follow-up schedule 24. Patients known to have a positive Hepatitis B serology 25. Patients with a history of previous therapy with tazemetostat or idasanutlin at any time 26. Patients with a history of previous therapy with EZH2 inhibitor 27. Patients with a known hypersensitivity to imatinib, nilotinib, dasatinib, bosutinib, ponatinib, idasanutlin or tazemetostat or any of their excipients 28. Patients with rare hereditary problems of galactose intolerance or the Lapp lactase deficiency or glucose-galactose malabsorption |
| Recruitment start date | 28/08/2019 |
| Recruitment end date | 28/02/2023 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
NHS Greater Glasgow and Clyde
Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 OYN
United Kingdom
1053 Great Western Road
Glasgow
G12 OYN
United Kingdom
IMPERIAL COLLEGE HEALTHCARE NHS TRUST
Hammersmith Hospital
Du Cane Road
London
W12 OHS
United Kingdom
Du Cane Road
London
W12 OHS
United Kingdom
OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
The Christie NHS Foundation Trust
The Christie Hospital
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
University Hospitals of Leicester
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
Leicester
LE1 5WW
United Kingdom
Leeds Teaching Hospital NHS TRUST
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
The Newcastle Upon Tyne Hospitals
Freeman Hospital
Freeman Road
Newcastle
NE7 7DN
United Kingdom
Freeman Road
Newcastle
NE7 7DN
United Kingdom
ROYAL LIVERPOOL AND BROADGREEN UNIVERSITY HOSPITALS NHS TRUST
ROYAL LIVERPOOL UNIVERSITY HOSPITAL
PRESCOT STREET
Liverpool
L7 8XP
United Kingdom
PRESCOT STREET
Liverpool
L7 8XP
United Kingdom
KING'S COLLEGE HOSPITAL NHS FOUNDATION TRUST
Kings College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Denmark Hill
London
SE5 9RS
United Kingdom
NHS Lothian
Western General Hospital
Crewe Road
Edinburgh
EH4 2XU
United Kingdom
Crewe Road
Edinburgh
EH4 2XU
United Kingdom
SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST
NORTHERN GENERAL HOSPITAL
HERRIES ROAD
SHEFFIELD
S5 7AU
United Kingdom
HERRIES ROAD
SHEFFIELD
S5 7AU
United Kingdom
Sponsor information
NHS Greater Glasgow and Clyde
Hospital/treatment centre
Hospital/treatment centre
Clinical Research and Development Office
WGACH
Dalnair Street
Glasgow
G3 8SW
Scotland
United Kingdom
| Website | https://www.nhsggc.org.uk/ |
|---|
University of Glasgow
University/education
University/education
Clinical Research and Development
West Glasgow Ambulatory Care Hospital
Dalnair Street
Glasgow
G3 8SW
Scotland
United Kingdom
| Website | https://www.gla.ac.uk/ |
|---|
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of this study will reported and disseminated via: 1. Peer reviewed scientific journals 2. Conference presentation 3. EudraCT 4. ISRCTN website 5. Cancer Research UK cancer help website Patients will not be individually informed, however results published in peer review journals will be made available, and a summary will be published on the CancerHelp website (http://cancerhelp.cancerresearchuk.org/). Patients will receive a Patient Results Letter when they have been registered on to the trial which acknowledges that the patient or the family of the patient may be interested in knowing the results when they are available. It explains when the trial is expected to be completed and when the summary of results are likely to be published. Updates of the trial, including final results will also be presented at the UK CML Patient Conference which is held annually. |
| IPD sharing plan | The CTU is committed to furthering cancer research by sharing de-identified individual-patient data (IPD) from its studies with others in the field who wish to use the data for high quality science. They are happy to consider proposals from researchers and will share IPD to the maximum extent, subject to individual study constraints relating to:- 1. Ethical approval and informed consent 2. Contractual and legal obligations 3. Publication timelines (data will not normally be shared prior to the publication of the primary results) In addition, all proposals will be reviewed for their scientific merit by the CTU and the study Chief Investigator. Only data relevant to the objectives of a particular proposal will be provided. An independent review process will be undertaken in cases of disagreement between the applicant and the CTU/Chief Investigator. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
06/11/2023: The study was stopped on 23/07/2021 with no patients recruited due to lack of funding.
24/09/2020: Cancer Research UK lay summary link added to plain English summary field.
11/06/2020: The public contact's details have been made publicly visible.
15/04/2020: Due to current public health guidance, recruitment for this study has been paused.
08/11/2019: Internal review.
05/08/2019: Internal review.
24/07/2019: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/05/2019 to 28/08/2019.
2. The recruitment end date was changed from 31/12/2022 to 28/02/2023.
3. The overall end date was changed from 01/12/2024 to 28/02/2025.
12/07/2019: Ethics approval details added.
21/06/2019: Internal review.
05/04/2019: Internal review.
