A Study for Older Adults With Acute Lymphoblastic Leukaemia (UKALL60+)
Recruitment status was Not yet recruiting
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.
Acute Lymphoblastic Leukaemia
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Phase 2 Study for Older Adults With Acute Lymphoblastic Leukaemia|
- 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.
- 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
|Study Start Date:||September 2012|
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
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616238
|Contact: UKALL60+ Trial Coordinator||0207 679 firstname.lastname@example.org|