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

Acute Myeloid Leukemia Clinical Trial

— AVALON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04070807
• Other study ID #: IRST204.04
• Status: Recruiting
• Start date: August 23, 2019
• Est. completion date: December 2020

Study information

• Verified date: April 2020
• Source: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Contact: Bernadette Verogen, DR
• Phone: +390544286058
• Email: cc.ubsc[@]irst.emr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with AML according to World Health Organization (WHO) 2016 classification

• Patient who have received any anti-BCL-2 treatment as single agent or in combination with other drugs from 1 Jan 2015 to 1 Apr 2019 outside clinical trials

Exclusion Criteria:

• Patient who have received any anti-BCL-2 treatment within a clinical trials

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
Italy	A.O. Pugliese Ciaccio	Catanzaro	CZ
Italy	ASST Cremona	Cremona	CR
Italy	AOU Careggi	Firenze	FI
Italy	Ospedale F. Spaziani	Frosinone	FR
Italy	Ospedale Santa Maria Goretti	Latina	LT
Italy	P.O. Vito Fazzi	Lecce	LE
Italy	Irst Irccs	Meldola	FC
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milano	MI
Italy	European Institute of Oncology	Milano
Italy	Fondazione IRCCS Ca' Granda OSPEDALE MAGGIORE POLICLINICO	Milano
Italy	Asst Monza	Monza	MB
Italy	Ospedale Santa Maria della Misericordia	Perugia	PG
Italy	Ospedale S.Spirito - ASL Pescara	Pescara	PE
Italy	Ospedale Roma S.Eugenio	Roma
Italy	AOU San Giovanni di Dio e Ruggi D'Aragona	Salerno	SA
Italy	IRCCS Casa Sollievo sofferenza	San Giovanni Rotondo	Foggia
Italy	Policlinico Santa Maria alle Scotte	Siena	SI
Italy	A.O. Ordine Mauriziano	Torino	TO
Italy	AOU Città della Salute e della Scienza di Torino	Torino	TO
Italy	Ospedale Ca' Foncello	Treviso	TV

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori	European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 18 months
Secondary	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	18 months
Secondary	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.	18 months
Secondary	Complete Remission	to describe the Complete Remission (CR), in terms of proportions, in response to therapy	18 months
Secondary	Complete Remission with incomplete hematologic recovery	to describe Complete Remission with incomplete hematologic recovery (CRi) in terms of proportions, in response to therapy	18 months
Secondary	Minimal Residual Disease	to describe Minimal Residual Disease, in terms of proportions, in response to therapy	18 months
Secondary	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	18 months
Secondary	Collection of number of hospitalizations	to describe healthcare resource utilization in terms of number of hospitalizations per patient	18 months
Secondary	Collection of days of hospitalizations	to describe healthcare resource utilization in terms of days of hospitalizations per patient	18 months
Secondary	Collection of number of clinical visits per patient	to describe healthcare resource utilization in terms of number of clinical visits per patient	18 months
Secondary	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	18 months
Secondary	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	18 months