A Study for Older Adults With Acute Lymphoblastic Leukaemia (UKALL60+)
This study is not yet open for participant recruitment.
Verified June 2012 by University College, London
Sponsor:
University College, London
Collaborators:
Cancer Research UK
Stichting Hemato-Oncologie voor Volwassenen Nederland
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01616238
First received: June 7, 2012
Last updated: June 8, 2012
Last verified: June 2012
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Purpose
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.
| Condition |
|---|
|
Acute Lymphoblastic Leukaemia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Phase 2 Study for Older Adults With Acute Lymphoblastic Leukaemia |
Resource links provided by NLM:
Further study details as provided by University College, London:
Primary Outcome Measures:
- Complete remission rate after 2 phases of induction [ Time Frame: Approximately 2 months after start of treatment ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Complete remission rate after 1 phase of induction [ Time Frame: Approximately 1 month after start of treatment ] [ Designated as safety issue: No ]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.
- Overall Survival at 1 year [ Time Frame: 1 year after registration ] [ Designated as safety issue: No ]Overall survival for all patients will be measured 1 year after registration
- Prognostic significance of molecularly determined minimal residual disease (MRD) at various time-points during therapy with respect to relapse occurrence. [ Time Frame: At diagnosis, 4 weeks, 8 weeks, 12 weeks after starting treatment ] [ Designated as safety issue: No ]MRD levels will be measured at distinct timepoints during the trial.
Biospecimen Retention: Samples Without DNA
Bone marrow aspirate and peripheral blood samples
| Estimated Enrollment: | 148 |
| Study Start Date: | September 2012 |
| Groups/Cohorts |
|---|
|
Philadelphia Positive Patients
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
Patients with Philadelphia negative ALL who are fit for intensive treatment will be allocated into this group.
|
|
Philadelphia -ve Patients- Intensive +
Patients in Belgium and the Netherlands with Philadelphia positive disease and who are fit for intensive treatment will be entered into this group
|
|
Philadelphia -ve Patients- Non Intensive
Patients with Philadelphia negative disease who are not fit for intensive chemotherapy will be entered into this group
|
|
Registration only
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.
|
Detailed Description:
The study will
- establish baseline expectations for Event Free Survival (EFS), Overall Survival (OS), MRD responses and quality of life measures for older patients of all ages and pre-morbid states;
- disclose how best to use knowledge of pre-morbid characteristics to apply the appropriate intensity of therapy in order to balance the best disease related outcomes against quality of life;
- establish national standards of care for this patient group;
- provide the essential platform for careful design of future randomised advanced phase studies of new therapeutic approaches and agents.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients over the age of 60 with acute lymphoblastic leukaemia.
Criteria
Inclusion Criteria:
- Age ≥ 60 with Acute Lymphoblastic Leukaemia (ALL)
- Newly diagnosed, previously untreated ALL (a steroid pre-phase of 5-7 days may be given before trial registration))
- Willing and able to give consent
Exclusion Criteria:
- Known HIV infection
- Blast transformation of CML
- Mature B-cell leukaemia i.e. Burkitts disease t(8,14)(q24 ;q32) and variant c-myc translocations e.g. t(2;8)(p12 ;q24), t(8;22)(q24;q11)
- Women who are pregnant or lactating
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616238
Contacts
| Contact: UKALL60+ Trial Coordinator | 0207 679 9860 | ukall60@ctc.ucl.ac.uk |
Sponsors and Collaborators
University College, London
Cancer Research UK
Stichting Hemato-Oncologie voor Volwassenen Nederland
More Information
No publications provided
| Responsible Party: | University College, London |
| ClinicalTrials.gov Identifier: | NCT01616238 History of Changes |
| Other Study ID Numbers: | UCL/11/0532 |
| Study First Received: | June 7, 2012 |
| Last Updated: | June 8, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 13, 2013