The trial proposed here attempts to reduce induction chemotherapy to phase I of standard induction in patients with B-precursor ALL. Induction phase II will be replaced by blinatumomab. The initial treatment phase is followed by sequential chemotherapy and further blinatumomab cycles.
Blinatumomab is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T-cell activation and a cytotoxic T-cell response against CD19 expressing cells. In Phase II-III clinical trials 43-69 % of the patients treated with blinatumomab in relapsed/refractory ALL with poor prognostic features, achieved a complete hematologic remission and around 80 % of these obtained a molecular remission as well. Blinatumomab thus has demonstrated significant antileukemic activity in relapsed/refractory adult ALL. The ultimate goal for optimised management of adult ALL is to integrate targeted compounds with known single-drug activity into first-line treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Patients will receive standard of care chemotherapy before blinatumomab, between blinatumomab cycles and after blinatumomab.
University Hospital of Frankfurt (Main)
Frankfurt am Main, Hesse, Germany
Uniklinik RWTH Aachen
Aachen, Germany
Hematologic and MRD response after induction therapy
Proportion of patients achieving a complete hematologic remission and a complete molecular remission (MRD response or complete MRD response) after induction therapy defined as one cycle of chemotherapy and one cycle of blinatumomab
Time frame: after induction therapy (up to 8 weeks)
Overall Survival
Probability of overall survival at 1 year after start of therapy
Time frame: 1 year after start of therapy
Adverse Events
Rate and grade of adverse events (AE) according to CTC-AE in induction phase I, blinatumomab induction and during blinatumomab cycle I, II and III
Time frame: continuously until end-of-core-study (week 43)
MRD response after induction and consolidation
Proportion of patients who achieve a MRD response or a complete MRD response after induction consolidation
Time frame: after induction and consolidation (up to 35 weeks)
Time to MRD relapse
Time to MRD relapse after prior achievement of MRD response or complete MRD response
Time frame: continuously until end of maintenance therapy (up to 27 months)
Continuous complete remission
Probability of continuous complete remission at 1 year
Time frame: 1 year after start of therapy
Relapse free survival
Probability of relapse free survival at 1 year
Time frame: 1 year after start of therapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Charité - Campus Benjamin Franklin
Berlin, Germany
Vivantes Klinikum Neukölln
Berlin, Germany
Städtisches Klinikum Braunschweig
Braunschweig, Germany
Klinikum Bremen Mitte
Bremen, Germany
Evangelisches Krankenhaus Essen-Werden
Essen, Germany
Universitätsklinikum Halle
Halle, Germany
Uniklinik Hamburg Eppendorf
Hamburg, Germany
Evangelisches Krankenhaus Hamm
Hamm, Germany
...and 11 more locations
Event-free survival
Probability of event-free survival at 1 year
Time frame: 1 year after start of therapy
Relapse localisation
Proportion of different relapse localisation in relation to total number of relapses
Time frame: In case of relapse, continuously until end of maintenance therapy (up to 27 months)
Quality of life
Quality of life measures (EORTC=European Organisation for Research and Treatment of Cancer standard scales) at different time-points during induction and consolidation; this is a multidimensional questionnaire with different scales per item such als functional scale, global health status and symptoms. Details are outlined in respective manuals (https://qol.eortc.org/manuals/)
Time frame: until end of maintenance therapy (up to 27 months)
Treatment deviation 1
Rate of treatment interruptions
Time frame: until end of treatment (up to 39 weeks)
Treatment deviation 2
Duration of treatment interruptions
Time frame: until end of treatment (up to 39 weeks)
Treatment deviation 3
Dose reductions
Time frame: until end of treatment (up to 39 weeks)
Treatment deviation 4
Mitigation strategies
Time frame: until end of treatment (up to 39 weeks)
Treatment deviation 5
Rate of withdrawals
Time frame: until end of treatment (up to 39 weeks)