The CTC offices are currently closed for refurbishment. Access to trial TMFs and patient records will be limited during this period. We will still be able to receive post during this time, but there may be a small delay in responding to this. Our fax lines may also be subject to disruption. Where possible, please direct all correspondence via email to trial-specific email addresses. We appreciate your patience and understanding.

Due to COVID-19 and current government guidance, UCL CTC staff continue to work remotely with limited access to the office. Please continue to email the trial specific mailbox with any urgent queries. For paper CRF trials, please continue to copy and scan CRFs to the trial inboxes (remove all patient identifiers except Trial Number and Initials) until further notice.

 
Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
30/12/2010
Funder:
University College London
Sponsor:
UCL
Chief Investigator:
Prof Adele Fielding
Recruitment target:
811
EudraCT number:
2009-012717-22
Contact details:
ctc.ukall14@ucl.ac.uk
Lay summary:
UKALL14
A randomised trial for adults with newly diagnosed acute lymphoblastic leukaemia
Description
Design: UKALL14 is a Phase III multicentre randomised trial for adults with newly-diagnosed Acute Lymphoblastic Leukaemia (ALL). The main randomisations investigate standard induction chemotherapy with or without Rituximab (for B-cell ALL) or Nelarabine (for T-cell ALL). 
Treatment: Initially, eligible patients will have two phases of induction chemotherapy. Patients with Philadelphia negative ALL will receive pegylated asparaginase as part of their induction. 50% of B-cell ALL patients will receive Rituximab weekly for 4 weeks during phase 1 induction. 50% of T-cell ALL patients will receive three doses of Nelarabine after phase 2 induction. 

After induction, patients with a matched sibling donor will receive a stem cell transplant, either myeloablative if aged ≤40 or non-myeloablative if aged ≥41.  Patients with no sibling donor will be assigned further treatment depending on their relapse risk. Patients with ‘high risk’ disease and who have a suitable unrelated donor will have a stem cell transplant. Patients who are ‘standard risk’, or who do not have a suitable donor will continue with intensification, consolidation and maintenance chemotherapy. 

Philadelphia positive patients will also receive Imatinib throughout treatment.

Patients will be followed up for at least 2 years post-treatment.

Patients will have regular minimal residual disease testing throughout treatment.

Key inclusion/exclusion criteria: Patients must be aged 25-65 years old (19-65 if Philadelphia positive) with newly-diagnosed, previously untreated ALL.  Patients cannot have known HIV infection, a history of hepatitis B or C infection, blast transformation of CML, mature B-cell leukaemia or be pregnant or lactating. 
Duration of recruitment: 7.5 years
Aim
The main aims of UKALL14 are to determine: whether Rituximab can improve outcomes for patients with B-cell ALL; whether nelarabine can improve outcomes for patients with T-cell ALL; whether patients can tolerate pegylated asparaginase, and whether they develop anti-asparaginase antibodies; and whether unrelated donor stem cell transplantation can improve outcomes for patients at a high risk of relapse. 

The trial also aimed to investigate the optimal scheduling of the anti-mucositis drug palifermin in myeloablative transplant patients, however as the drug is no longer available, this aim will not be fully addressed.

Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
NameVersionCurrent versRelease dateDownload
Protocol v1212.0 Current 26/06/2018
Protocol v11.0 Historic 11/11/2009
Protocol v1111.0 Historic 11/09/2017
Protocol v22.0 Historic 17/05/2010
Protocol v33.0 Historic 18/08/2010
Protocol v44.0 Historic 24/04/2012
Protocol v55.0 Historic 20/07/2012
Protocol v66.0 Historic 20/06/2014
Protocol v6.16.1 Historic 27/01/2015
Protocol v77.0 Historic 09/09/2015
Protocol v88.0 Historic 12/05/2016
Protocol v99.0 Historic 17/02/2017
Trial documents
NameTypeVersionCurrent versRelease dateDownload
Annual follow up formCRF3 Current 20/08/2020
Annual follow up form (relapse and second cancer)CRF3 Current 20/08/2020
Consent FormInformedConsentForm1.2 Current 29/04/2015
Consent Form - Genetic Testing - Bone MarrowInformedConsentForm1.0 Current 09/09/2015
Consent Form - Genetic Testing - Buccal SwabInformedConsentForm1.0 Current 09/09/2015
Consent Form - Pregnancy Monitoring - PartnersInformedConsentForm1.0 Current 01/08/2012
Consent Form - Pregnancy Monitoring - PatientInformedConsentForm1.0 Current 01/08/2012
CRF - Adverse Event ConsolidationCRF3.0 Current 27/11/2015
CRF - Adverse Event Induction Phase 2CRF3.0 Current 27/11/2015
CRF - Adverse Event Induction Phase1CRF3.0 Current 27/11/2015
CRF - Adverse Event IntensificationCRF3.0 Current 27/11/2015
CRF - Adverse Event TransplantCRF3.0 Current 27/11/2015
CRF - AE of Special InterestCRF1.0 Current 27/11/2015
CRF - Annual Follow up (Not in CR)CRF2.0 Current 20/04/2015
CRF - Centre TransferCRF3.0 Current 10/03/2016
CRF - Consent Constitutional DNACRF1.0 Current 27/11/2015
CRF - Consolidation TreatmentCRF2.0 Current 20/04/2015
CRF - CytogeneticsCRF3.0 Current 03/05/2013
CRF - DeathCRF3.0 Current 27/11/2015
CRF - Induction Treatment Phase 1CRF3.0 Current 20/04/2015
CRF - Induction Treatment Phase 2CRF3.0 Current 20/04/2015
CRF - Intensification TreatmentCRF2.0 Current 20/04/2015
CRF - Late EffectsCRF1.0 Current 10/03/2016
CRF - Lost to Follow UpCRF3.0 Current 27/11/2015
CRF - Maintenance TreatmentCRF1.0 Current 08/12/2010
CRF - Post Induction Registration MaintenanceCRF2.0 Current 20/04/2015
CRF - Post Induction Registration TransplantCRF2.0 Current 20/04/2015
CRF - Post Induction Treatment Allocation (PITA)CRF2.0 Current 20/04/2015
CRF - RegistrationCRF6.0 Current 27/11/2015
CRF - 'Registration only' Annual Followup v2CRF2.0 Current 20/08/2018
CRF - 'Registration only' GvHD Form v2CRF2.0 Current 20/08/2018
CRF - 'Registration only' Induction Treatment v2CRF2.0 Current 20/08/2018
CRF - 'Registration only' Post-Induction Chemotherapy v2CRF2.0 Current 20/08/2018
CRF - 'Registration only' Sub-study Entry v2CRF2.0 Current 20/08/2018
CRF - 'Registration only' Transplant to Day100 v2CRF2.0 Current 20/08/2018
CRF - RelapseCRF2.0 Current 19/04/2011
CRF - Second CancerCRF2.0 Current 20/04/2015
CRF - TransplantCRF2.0 Current 20/04/2015
CRF - Treatment SummaryCRF4.0 Current 27/11/2015
CRF Completion Guidelines v5GuidanceDdocument5 Current 14/03/2018
CRF 'Registration only' Completion Guidelines v2GuidanceDdocument2.0 Current 20/08/2018
CTC contact listOther10 Current 09/12/2019
CTCAEOther4.03 Current
Drug Supply GuidelinesGuidanceDdocument4 Current 12/03/2018
File Note: SAE Report v3 not disseminatedOtherN/A Current 22/01/2016
GDPR Transparency StatementPatientInformationSheet1 Current 11/06/2018
GDPR Transparency Statement Tracker PatientInformationSheetN/A Current 24/05/2018
GP Letter v1GPletter1.0 Current 11/11/2009
HRA Approval - protocol v12Amendment12.0 Current 10/09/2018
IMP - Destruction log templateOther1.0 Current 29/11/2010
IMP - Label RA submission form - NelarabineOtherN/A Current 21/10/2010
IMP - Label RA submission form - OncasparOtherN/A Current 21/10/2010
IMP - Label RA submission form – PaliferminOtherN/A Current 21/10/2010
IMP - Label RA submission form - RituximabOtherN/A Current 21/10/2010
IMP - Rituximab Certificate of Clinical Trial SupplyOther1.0 Current 01/01/2010
IMP - Temperature Monitoring Log TemplateOther1.0 Current 29/11/2010
IMP - UCL CTC Notification of Temperature Excursion FormOther2.0 Current 25/02/2014
IMP - UCL CTC Pharmacy Procedure for Reporting Temperature ExcursionsOther1.0 Current 17/09/2010
Incident Report formOther3.0 Current 31/07/2018
Insurance 2020-2021Other2020-2021 Current 28/07/2020
ISF - Site Quality Control ChecklistOther14 Current 20/09/2018
Laboratory - Sample Request Form Other5.0 Current 23/11/2017
MHRA Approval - protocol v12Amendment12.0 Current 13/08/2018
Monitoring PlanOther4.0 Current 18/10/2016
Newsletter - Spring 2017OtherN/A Current 19/04/2017
Patient Card v1PatientInformation1.0 Current 11/11/2009
Patient Information Sheet - Additional Genetic Testing - Bone MarrowPatientInformationSheet1.0 Current 09/09/2015
Patient Information Sheet - Additional Genetic Testing - Buccal swabPatientInformationSheet1.0 Current 09/09/2015
Patient Information Sheet - Additional PIS Driving and MachinesPatientInformationSheet1.1 Current 31/08/2017
Patient Information Sheet - Pregnancy Monitoring - PartnersPatientInformationSheet1.0 Current 01/08/2012
Patient Information Sheet - Pregnancy Monitoring - PatientPatientInformationSheet1.0 Current 01/08/2012
Patient Information Sheet v10.0 PatientInformation10 Current 28/06/2018
Patient Information Sheet/ Consent form - 'Registration Only' Sub-study v3.0PatientInformationSheet3.0 Current 28/06/2018
Patient Information Version HistoryPatientInformationSheetN/A Current 28/09/2018
Patient Screening - Informed Consent LogTrialsLog1.0 Current 08/12/2011
Patient Screening - Log InstructionsOther1.0 Current 08/12/2010
Patient Screening - Patient Screening LogTrialsLog1.0 Current 08/12/2010
Pregnancy ReportSAEform3.0 Current 23/11/2017
Pregnancy Report Additional PageSAEform1.0 Current 08/12/2010
PSF - Site Quality Control ChecklistOther12.0 Current 20/09/2018
REC Approval - protocol v12.0Amendment12 Current 27/07/2018
Regulatory Guidelines - Declaration of HelsinkiOtherN/A Current 01/10/2008
Regulatory Guidelines - Principles of ICH GCPOtherN/A Current
SAE Form GuidanceGuidanceDdocument5 Current 04/09/2018
SAE ReportCRF6 Current 04/09/2018
SAE Report Additional PagesSAEform1.0 Current 08/12/2010
SAE Report Fax HeaderOtherN/A Current
Site Information - Investigator Registration FormOther1.0 Current 10/08/2011
Site Information - Site Registration FormOther1.0 Current 04/07/2011
Site Information - Staff Delegation LogTrialsLog1.0 Current 08/08/2011
Study Drug Supplies - Drug Accountability Log Consolidation OncasparOther2.0 Current 18/05/2015
Study Drug Supplies - Drug Accountability Log Intensification OncasparOther2.0 Current 18/05/2015
Study Drug Supplies - Drug Accountability Log Palifermin treatmentOther2.0 Current 18/05/2015
Study Drug Supplies - Drug Accountability Log Phase 1 OncasparOther2.0 Current 18/05/2015
Study Drug Supplies - Drug Accountability Log Phase 1 RituximabOther2.0 Current 18/05/2015
Study Drug Supplies - Drug Accountability Log Phase 2 NelarabineOther2.0 Current 18/05/2015
Study Drug Supplies - Nelarabine Order FormOther1.0 Current 22/10/2010
Study Drug Supplies - Oncaspar order formOther4 Current 28/02/2018
Study Drug Supplies - Palifermin Order FormOther4 Current 09/09/2015
Study Drug Supplies - Rituximab Order FormOther1.0 Current 22/10/2010
Study Drug Supplies - Stock Balance Log NelarabineOther1.0 Current 18/05/2015
Study Drug Supplies - Stock Balance Log OncasparOther1.0 Current 18/05/2015
Study Drug Supplies - Stock Balance Log PaliferminOther1.0 Current 18/05/2015
Study Drug Supplies - Stock Balance Log RituximabOther1.0 Current 18/05/2015
SUSAR Quarterly Line Listings - Apr18-Jun18OtherN/A Current
UCL Sponsorship LetterOtherN/A Current 25/03/2009
UKALL14 Training Manual - Main studyGuidanceDdocument1.0 Current 27/11/2017
UKALL14 Training slides - 'Registration only' Sub-studyGuidanceDdocument1 Current 15/11/2017
Consent FormInformedConsentForm1 Historic 11/11/2009
Consent Form InformedConsentForm1.1 Historic 03/09/2010
CRF - Annual Follow upCRF2.0 Historic 20/04/2015
CRF - Annual Follow up (Relapse/Second Cancer)CRF2.0 Historic 20/04/2015
CRF - 'Registration only' Annual Followup CRF1.0 Historic 06/12/2017
CRF - 'Registration only' GvHD FormCRF1.0 Historic 06/12/2017
CRF - 'Registration only' Induction Treatment CRF1.1 Historic 25/01/2018
CRF - 'Registration only' Post-Induction Chemotherapy CRF1.1 Historic 25/01/2018
CRF - 'Registration only' Sub-study EntryCRF1.0 Historic 24/11/2017
CRF - 'Registration only' Transplant to Day100 CRF1.0 Historic 06/12/2017
CRF Completion GuidelinesGuidanceDdocument4.0 Historic 10/03/2016
CRF 'Registration only' Induction Treatment formCRF1 Historic 18/01/2018
CRF 'Registration only' Post-Induction Chemotherapy formCRF1 Historic 18/01/2018
CRF 'Registration-only' Completion GuidelinesGuidanceDdocument1.1 Historic 20/03/2018
CTC contact listOther8 Historic 11/02/2019
CTC contact listOther9 Historic 06/03/2019
CTC contact list Other7.0 Historic 29/08/2018
CTC Contact listOther6.0 Historic 08/02/2017
Incident Report formOther2.0 Historic 25/06/2015
Insurance 2009-2010Other2009-2010 Historic
Insurance 2010-2011Other2010-2011 Historic
Insurance 2011-2012Other2011-2012 Historic
Insurance 2012-2013Other2012-2013 Historic
Insurance 2013-2014Other2013-2014 Historic
Insurance 2014-2015Other2014-2015 Historic
Insurance 2015-2016Other2015-2016 Historic
Insurance 2016- 2017Other2016-2017 Historic
Insurance 2017-2018Other2017-2018 Historic
Insurance 2018-2019Other2018-2019 Historic
Insurance 2019-2020Other2019-2020 Historic
Insurance UCL LetterOtherN/A Historic 15/05/2009
ISF - Site Quality Control ChecklistOther9.0 Historic 30/03/2017
Laboratory - Price List UCL Adult ALL LabOtherN/A Historic 08/08/2010
Laboratory - Sample Request FormOther3.0 Historic 09/11/2015
MHRA Approval - LabellingAmendmentN/A Historic 03/11/2010
MHRA Approval - PIS v2AmendmentN/A Historic 23/02/2010
MHRA Approval - protocol v11Amendment11 Historic 21/11/2017
MHRA Approval - Protocol v2AmendmentN/A Historic 21/06/2010
MHRA Approval - Protocol v3AmendmentN/A Historic 17/09/2010
MHRA Approval - Protocol v4AmendmentN/A Historic 09/05/2012
MHRA Approval - Protocol v5AmendmentN/A Historic 27/09/2012
MHRA Approval - Protocol v6AmendmentN/A Historic 15/07/2014
MHRA Approval - Protocol v6.1AmendmentN/A Historic 11/03/2015
MHRA Approval - Protocol v7AmendmentN/A Historic 15/11/2015
MHRA Approval - Protocol v8AmendmentN/A Historic 15/06/2016
MHRA Approval - Protocol v9AmendmentN/A Historic 13/03/2017
MHRA Initial ApprovalOtherN/A Historic 13/01/2010
MHRA Urgent Safety Measure correspondenceOtherN/A Historic 23/04/2012
Newsletter - Christmas 2011OtherN/A Historic 01/12/2011
Newsletter - Christmas 2012OtherN/A Historic 01/12/2012
Newsletter - Christmas 2013OtherN/A Historic 01/12/2013
Newsletter - Christmas 2014OtherN/A Historic 01/12/2014
Newsletter - Christmas 2015OtherN/A Historic 01/12/2015
Newsletter - Christmas 2019OtherN/A Historic
Newsletter - Easter 2011OtherN/A Historic 01/03/2011
Newsletter - Easter 2012OtherN/A Historic 01/03/2012
Newsletter - Easter 2013OtherN/A Historic 01/03/2013
Newsletter - January 2019OtherN/A Historic
Newsletter - May 2015OtherN/A Historic 01/05/2015
Newsletter - MRD lab moveOtherN/A Historic 15/05/2015
Newsletter - Summer 2018OtherN/A Historic
Patient Information SheetPatientInformationSheet7.0 Historic 17/02/2017
Patient Information Sheet - Additional Suspension of PaliferminOther1 Historic 13/04/2016
Patient Information Sheet v2PatientInformationSheet2.0 Historic 24/12/2009
Patient Information Sheet v2.1PatientInformationSheet2.1 Historic 17/05/2010
Patient Information Sheet v3PatientInformationSheet3.0 Historic 18/08/2010
Patient Information Sheet v4PatientInformationSheet4.0 Historic 01/08/2012
Patient Information Sheet v4.1PatientInformationSheet4.1 Historic 16/05/2013
Patient Information Sheet v5PatientInformationSheet5.0 Historic 13/03/2014
Patient Information Sheet v5.1PatientInformationSheet5.1 Historic 16/06/2014
Patient Information Sheet v5.2PatientInformationSheet5.2 Historic 29/04/2015
Patient Information Sheet v5.3PatientInformationSheet5.3 Historic 09/09/2015
Patient Information Sheet v6PatientInformationSheet6.0 Historic 12/05/2016
Patient Information Sheet v8PatientInformationSheet8.0 Historic 09/08/2017
Patient Information Sheet v9PatientInformationSheet9.0 Historic 11/09/2017
Patient Information Sheet/Consent form - 'Registration only' sub-study v2.0PatientInformationSheet2.0 Historic 11/09/2017
Patient LogOther1 Historic 08/12/2010
Pregnancy ReportSAEform2.0 Historic 21/01/2016
PSF - Site Quality Control ChecklistOther8.0 Historic 30/03/2017
REC Approval - Consent periodAmendmentN/A Historic 24/08/2011
REC Approval - PIS v4.1AmendmentN/A Historic 17/05/2013
REC Approval - PIS v5AmendmentN/A Historic 02/04/2014
REC Approval - PIS v5.2AmendmentN/A Historic 21/05/2015
REC Approval - PIS v8AmendmentN/A Historic 05/09/2017
REC Approval - protocol v11.0Amendment11 Historic 30/10/2017
REC Approval - Protocol v2AmendmentN/A Historic 07/06/2010
REC Approval - Protocol v3AmendmentN/A Historic 08/09/2010
REC Approval - Protocol v4AmendmentN/A Historic 16/05/2012
REC Approval - Protocol v5AmendmentN/A Historic 23/08/2012
REC Approval - Protocol v6AmendmentN/A Historic 09/07/2014
REC Approval - Protocol v6.1AmendmentN/A Historic 23/02/2015
REC Approval - Protocol v7AmendmentN/A Historic 30/09/2015
REC Approval - Protocol v8AmendmentN/A Historic 06/06/2016
REC Approval - Protocol v9AmendmentN/A Historic 09/03/2017
REC Initial ApprovalOtherN/A Historic 13/01/2010
'Registration-only' CRF Completion GuidelinesGuidanceDdocument1 Historic 14/03/2018
Rejection of Protocol v10 amendment correspondenceOther12/07/2017 Historic 12/07/2017
SAE Form GuidanceGuidanceDdocument4.0 Historic 23/11/2017
SAE Form GuidanceGuidanceDdocument3.0 Historic 10/02/2017
SAE ReportSAEform4.0 Historic 21/01/2016
SAE ReportOther5.0 Historic 23/11/2017
SPC - AtrianceOther30/10/2020 Historic 30/10/2020
SPC - AtrianceOtherN/A Historic 01/04/2015
SPC - KepivanceOtherN/A Historic 01/05/2013
SPC - KepivanceOther08/03/2016 Historic 08/03/2016
SPC - OncasparOtherNov 2020 Historic 01/11/2020
SPC - OncasparOtherN/A Historic 01/06/2014
SPC - RituximabOther27/02/2020 Historic 27/02/2020
SPC - Roche Six Monthly SUSAR Report May13-Nov13OtherN/A Historic 27/11/2013
SPC - Roche Six Monthly SUSAR Report May14-Nov14OtherN/A Historic 18/11/2014
SPC - Roche Six Monthly SUSAR Report May15-Nov15OtherN/A Historic 18/11/2015
SPC - Roche Six Monthly SUSAR Report Nov13-May14OtherN/A Historic 26/05/2014
SPC - Roche Six Monthly SUSAR Report Nov14-May15OtherN/A Historic 18/05/2015
Study Drug Supplies - Drug Supply GuidelinesOther2.1 Historic 25/02/2014
Study Drug Supplies - Drug Supply GuidelinesOther3.0 Historic 23/11/2017
Study Drug Supplies - Oncaspar Order FormOther3.0 Historic 11/02/2013
SUSAR Quarterly Line Listing - 01Apr20 - 30Jun20OtherN/A Historic 30/06/2020
SUSAR Quarterly Line Listing - 01Apr21 - 30Jun21 OtherN/A Historic
SUSAR Quarterly Line Listing - 01Jan20 - 31Mar20OtherNA Historic 31/03/2020
SUSAR Quarterly Line Listing - 01Jan21 - 31Mar21OtherN/A Historic 31/03/2021
SUSAR Quarterly Line Listing - 01Jul18-30Sep18OtherN/A Historic
SUSAR Quarterly Line Listing - 01Jul20 - 30Sep20OtherN/A Historic 30/09/2020
SUSAR Quarterly Line Listing - 01Oct20 - 31Dec20OtherN/A Historic 31/12/2020
SUSAR Quarterly Line Listings - 01Apr19-30Jun19Othern/a Historic
SUSAR Quarterly Line Listings - 01Jan2019-31Mar2019Othern/a Historic
SUSAR Quarterly Line Listings - 01Jul19-30Sep19Othern/a Historic
SUSAR Quarterly Line Listings - 01Oct18-31Dec18Othern/a Historic
SUSAR Quarterly Line Listings - 01Oct19-31Dec19Othern/a Historic
SUSAR Quarterly Line Listings - Apr15-Jun15OtherN/A Historic
SUSAR Quarterly Line Listings - Apr16-Jun16OtherN/A Historic
SUSAR Quarterly Line Listings - Apr17-Jun17OtherN/A Historic
SUSAR Quarterly Line Listings - Aug12OtherN/A Historic
SUSAR Quarterly Line Listings - Jan15-Mar15OtherN/A Historic
SUSAR Quarterly Line Listings - Jan16-Mar16OtherN/A Historic
SUSAR Quarterly Line Listings - Jan17-Mar17OtherN/A Historic
SUSAR Quarterly Line Listings - Jan18-Mar18OtherN/A Historic
SUSAR Quarterly Line Listings - Jul15-Sep15OtherN/A Historic
SUSAR Quarterly Line Listings - Jul16-Sep16OtherN/A Historic
SUSAR Quarterly Line Listings - Jul17-Sep17OtherN/A Historic
SUSAR Quarterly Line Listings - Jun14-Sept14OtherN/A Historic
SUSAR Quarterly Line Listings - Oct15-Dec15OtherN/A Historic
SUSAR Quarterly Line Listings - Oct16-Dec16OtherN/A Historic
SUSAR Quarterly Line Listings - Oct17-Dec17OtherN/A Historic
SUSAR Quarterly Line Listings - Sept14-Dec14OtherN/A Historic
UKALL14 - Patient Information Sheet v7.0 17.02.2017_20022020_0.docPatientInformationSheet7 Historic 17/02/2017
UKALL14 Prescriptions - Memorandum to Investigators and PharmacistsOtherN/A Historic 26/01/2016
Urgent Safety Measure CorrespondenceOther24/04/2012 Historic 24/04/2012
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Telephone:
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