Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

B-cell Lymphoma

Lymphosarcoma

Acute Graft Versus Host Disease

Bernadette Verogen, DR

Oriana Nanni

Alfredo Molteni

Stefano Molica

Claudio Cerchione, MD

Matteo Piccini

Nicola Cascavilla

Vincenza Martini

Nicola Di Renzo

Giuseppe Cimino

Monica Fumagalli

Roberto Cairoli

Prassede Salutari

Maria Paola Martelli

Carmine Selleri, MD

Monica Bocchia

Ernesta Audisio, MD

Alessandro Cignetti

Michele Gottardi, MD

Elisabetta Todisco, MD

Nicola Fracchiolla, MD

Elisabetta Abruzzese, MD, PhD

Giovanni Martinelli, MD

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.

Italian Observational Study of Patients With Acute Myeloid Leukemia Treated With Small Molecule Inhibiting BCL-2

Italian Observational Study of Patients With Acute Myeloid Leukemia Treated With Small Molecule Inhibiting B-cell Lymphoma 2 (BCL-2)

To evaluate the toxicity profile of the therapy with anti-BCL-2 in patients with AML.

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

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.

to describe the Complete Remission (CR), in terms of proportions, in response to therapy

to describe Complete Remission with incomplete hematologic recovery (CRi) in terms of proportions, in response to therapy

to describe Minimal Residual Disease, in terms of proportions, in response to therapy

to describe the incidence of successful bridge to allogeneic transplant, in terms of proportions, in response to therapy

to describe healthcare resource utilization in terms of number of hospitalizations per patient

to describe healthcare resource utilization in terms of days of hospitalizations per patient

to describe healthcare resource utilization in terms of number of clinical visits per patient

to describe healthcare resource utilization in terms of number of accesses in Day Hospital per patient

to describe healthcare resource utilization in terms of number of accesses in Emergency Care Units per patient

Spots Global Cancer Trial Database for anti bcl2 inhibitors