This is a multi-center retrospective observational study. Every patient with Acute Myeloid Leukemia (AML) treated with anti-B-cell lymphoma 2 (BCL2) treatment outside clinical trial from 1st January 2015 up to 01 April 2019 may be included in this study. No additional drug/procedures/patient visits in comparison with the usual clinical practice are planned for the study. The decision to treat patient with ant-BCL2 inhibitors is made by the physician based on his clinical judgment, independently from the decision to include the patient in this study.
In phase 1-2 studies, anti BCL-2 treatment has shown evidence of anti-leukemic activity as single agent and in combination and proved to be particularly effective in providing a deep response, with an acceptable safety profile. Since 2015 anti-BCL2 treatment has been available in other indications and in off-label use in Italy. In this non-interventional retrospective study, toxicity, effectiveness and costs assessment data will be collected from patients with AML, to improve the knowledge about anti-BCL2 treatment in clinical practice. Collecting and analyzing data from a large unbiased patient-set receiving anti-BCL2, would enlarge our knowledge on therapies inhibiting BCL2. This is a multi-center retrospective observational study. Every patient with AML treated with anti-BCL2 treatment outside clinical trial from 1st January 2015 up to 01 April 2019 may be included in this study. No additional drug/procedures/patient visits in comparison with the usual clinical practice are planned for the study. The decision to treat patient with ant-BCL2 inhibitors is made by the physician based on his clinical judgment, independently from the decision to include the patient in this study. As this study is intended to be purely observational (not interventional), the patient's medical records will be the source of all data to be recorded. No additional procedures/patient visits should be planned in the study with respect to clinical practice. Clinical data (treatment, survival, adverse events) will be collected for patients enrolled.
Study Type
OBSERVATIONAL
Enrollment
70
ASST Cremona
Cremona, CR, Italy
RECRUITINGA.O. Pugliese Ciaccio
Catanzaro, CZ, Italy
RECRUITINGIrst Irccs
Meldola, FC, Italy
RECRUITINGAOU Careggi
Florence, FI, Italy
RECRUITINGIRCCS Casa Sollievo sofferenza
San Giovanni Rotondo, Foggia, Italy
RECRUITINGOspedale F. Spaziani
Frosinone, FR, Italy
RECRUITINGP.O. Vito Fazzi
Lecce, LE, Italy
RECRUITINGOspedale Santa Maria Goretti
Latina, LT, Italy
RECRUITINGAsst Monza
Monza, MB, Italy
RECRUITINGASST Grande Ospedale Metropolitano Niguarda
Milan, MI, Italy
RECRUITING...and 10 more locations
Incidence of Adverse Events of grade 3 and 4 (NCTCAE version 5.0)
To evaluate the toxicity profile of the therapy with anti-BCL-2 in patients with AML.
Time frame: up to 18 months
Overall Survival
to describe the clinical outcomes in terms of Overall Survival (OS) defined as the number of days between the first study drug administration and death from any cause
Time frame: 18 months
Disease Free Survival (DFS)
to describe Disease Free Survival, defined as the number of days between the first study drug administration and any event including disease progression or death from any cause (both median and restricted mean) whichever occurs first.
Time frame: 18 months
Complete Remission
to describe the Complete Remission (CR), in terms of proportions, in response to therapy
Time frame: 18 months
Complete Remission with incomplete hematologic recovery
to describe Complete Remission with incomplete hematologic recovery (CRi) in terms of proportions, in response to therapy
Time frame: 18 months
Minimal Residual Disease
to describe Minimal Residual Disease, in terms of proportions, in response to therapy
Time frame: 18 months
Incidence of successful bridge to allogeneic transplant
to describe the incidence of successful bridge to allogeneic transplant, in terms of proportions, in response to therapy
Time frame: 18 months
Collection of number of hospitalizations
to describe healthcare resource utilization in terms of number of hospitalizations per patient
Time frame: 18 months
Collection of days of hospitalizations
to describe healthcare resource utilization in terms of days of hospitalizations per patient
Time frame: 18 months
Collection of number of clinical visits per patient
to describe healthcare resource utilization in terms of number of clinical visits per patient
Time frame: 18 months
Collection of number of accesses Day Hospital per patient
to describe healthcare resource utilization in terms of number of accesses in Day Hospital per patient
Time frame: 18 months
Collection of number of accesses in Emergency Care Units per patient
to describe healthcare resource utilization in terms of number of accesses in Emergency Care Units per patient
Time frame: 18 months
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