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| Name | Class |
|---|---|
| Cancer Research UK | OTHER |
| Stichting Hemato-Oncologie voor Volwassenen Nederland | OTHER |
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The NCRI Adult ALL sub-group propose to collaborate with the Dutch/Belgian group HOVON to carry out a prospective, non randomised multi-arm study (including a choice of regimen intensity) to investigate the safety, tolerability and feasibility of a standardised therapy protocol for patients ≥ 60 years old with de novo ALL. The overall aim is define a basic standard of care upon which trials of novel therapies will be based in future. The design of the study will enable collection of a comprehensive dataset regarding the clinical outcome, Complete Response Rate (CR) and Minimal Residual Disease (MRD) response rates in a previously completely uncharacterised population, thus providing the essential platform for designing future randomised advanced phase studies in which new therapeutic approaches and novel therapies can be prospectively investigated.
The study will
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Philadelphia Positive Patients | Experimental | All patients with Philadelphia positive ALL will be treated in this group and will receive a standard imatinib-containing chemotherapy regimen |
|
| Philadelphia -ve Patients- Intensive | Experimental | Patients with Philadelphia negative ALL who are fit for intensive treatment will be allocated into this group. |
|
| Philadelphia -ve Patients- Intensive + | Experimental | Patients with Philadelphia negative disease and who are fit for intensive treatment will be entered into this group |
|
| Philadelphia -ve Patients- Non Intensive | Experimental | Patients with Philadelphia negative disease who are not fit for intensive chemotherapy will be entered into this group |
|
| Registration only | No Intervention | Patients with either Philadelphia positive or negative ALL who do not wish to enter the study will be allocated to this group for data collection purposes only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | Treatment for all pathways consists of Induction, Intensification (where applicable), Consolidation and Maintenance therapy during which combination chemotherapy is given for up to 2.5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate after 2 phases of induction | All patients will be assessed for their remission status at the end of Phase 2 induction. The CR rate at this timepoint will then be calculated. | Approximately 2 months after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate after 1 phase of induction | All patients will be assessed for their remission status at the end of Phase 1 induction. The CR rate at this timepoint will then be calculated. | Approximately 1 month after start of treatment |
| Overall Survival at 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof Adele Fielding | University College London Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Rotterdam | Netherlands | ||||
| NHS Lanarkshire - Monklands |
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Overall survival for all patients will be measured 1 year after registration |
| 1 year after registration |
| Prognostic significance of molecularly determined minimal residual disease (MRD) at various time-points during therapy with respect to relapse occurrence. | MRD levels will be measured at distinct timepoints during the trial. | At diagnosis, 4 weeks, 8 weeks, 12 weeks after starting treatment |
| Tolerability of treatment as determined by occurrence of key adverse effects | Patients in arms A-D will be assessed for adverse events at distinct timepoints during the trial | Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks after starting treatment |
| Duration of in-patient hospitalisation | All patients will be assessed for the number of days they have spent as in-patients at distinct timepoints during the trial. | Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28 after starting treatment and every 3 months during maintenance |
| Relationship between performance status/co-morbidity and treatment option chosen | At registration |
| Quality of life aspects assessed at diagnosis/baseline at various time points | Registration, Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28 after starting treatment, before starting maintenance and at the end of maintenance |
| Airdrie |
| United Kingdom |
| Blackpool Victoria Hopsital | Blackpool | United Kingdom |
| Royal Bournemouth Hospital | Bournemouth | United Kingdom |
| Bradford Royal Infirmary | Bradford | United Kingdom |
| Bristol Haematology and Oncology Centre | Bristol | United Kingdom |
| University Hospital of Wales | Cardiff | United Kingdom |
| Castle Hill Hospital | Cottingham | United Kingdom |
| Russells Hall Hospital | Dudley | United Kingdom |
| Ninewells Hospital | Dundee | United Kingdom |
| NHS Lothian - Western General Hospital | Edinburgh | United Kingdom |
| Beatson West of Scotland Cancer Centre | Glasgow | United Kingdom |
| New Victoria Hospital and Southern General Hospital | Glasgow | United Kingdom |
| Northwick Park Hospital | Harrow | United Kingdom |
| St James' Hospital, Leeds | Leeds | United Kingdom |
| Leicester Royal Infirmary | Leicester | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | United Kingdom |
| King's College Hospital NHS Foundation Trust | London | United Kingdom |
| St Bartholomew's Hospital | London | United Kingdom |
| St George's Hospital | London | United Kingdom |
| The Christie Hospital | Manchester | United Kingdom |
| Arrowe Park Hospital | Metropolitan Borough of Wirral | United Kingdom |
| James Cook University Hospital | Middlesbrough | United Kingdom |
| Churchill Hospital, Oxford | Oxford | United Kingdom |
| Derriford Hospital | Plymouth | United Kingdom |
| Poole General Hospital | Poole | United Kingdom |
| St Helen's & Knowlsey Teaching Hospitals | Prescot | United Kingdom |
| Salisbury District Hospital | Salisbury | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | United Kingdom |
| Royal MarsdenHospital | Sutton | United Kingdom |
| Great Western Hospital | Swindon | United Kingdom |
| Musgrove Park | Taunton | United Kingdom |
| Torbay Hospital | Torquay | United Kingdom |
| Sandwell General Hospital | West Bromwich | United Kingdom |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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