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Acute Myeloid LeukemiaAVALONNCT04070807

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

An observational study of Acute Myeloid Leukemia, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 20 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
How many people
70 participants
Where
20 sitesItaly
Study dates
23 Aug 2019to Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: AML according to World Health Organization (WHO) 2016 classification 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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

20 sites in 1 country.

Bernadette Verogen, DR contact

+390544286058

cc.ubsc@irst.emr.it

Oriana Nanni contact

+390543739266

oriana.nanni@irst.emr.it

20 sites in 1 country

Italy20 sites, 20 recruiting

  • A.O. Pugliese Ciaccio

    Catanzaro, CZ, 88100

    Stefano Molica

    Recruiting

  • ASST Cremona

    Cremona, CR, 26100

    Alfredo Molteni

    Recruiting

  • AOU Careggi

    Florence, FI

    Matteo Piccini

    Recruiting

  • Ospedale F. Spaziani

    Frosinone, FR, 03100

    Vincenza Martini

    Recruiting

  • Ospedale Santa Maria Goretti

    Latina, LT, 04100

    Giuseppe Cimino

    Recruiting

  • P.O. Vito Fazzi

    Lecce, LE, 73100

    Nicola Di Renzo

    Recruiting

  • Irst Irccs

    Meldola, FC, 47014

    Claudio Cerchione, MD

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, MI, 20162

    Roberto Cairoli

    Recruiting

  • European Institute of Oncology

    Milan

    Elisabetta Todisco, MD

    Recruiting

  • Fondazione IRCCS Ca' Granda OSPEDALE MAGGIORE POLICLINICO

    Milan

    Nicola Fracchiolla, MD

    Not yet recruiting

  • Asst Monza

    Monza, MB, 20900

    Monica Fumagalli

    Recruiting

  • Ospedale Santa Maria della Misericordia

    Perugia, PG, 06156

    Maria Paola Martelli

    Recruiting

  • Ospedale S.Spirito - ASL Pescara

    Pescara, PE, 65124

    Prassede Salutari

    Recruiting

  • Ospedale Roma S.Eugenio

    Roma, 00144

    Elisabetta Abruzzese, MD, PhD

    Recruiting

  • AOU San Giovanni di Dio e Ruggi D'Aragona

    Salerno, SA, 84131

    Carmine Selleri, MD

    Recruiting

  • IRCCS Casa Sollievo sofferenza

    San Giovanni Rotondo, Foggia, 71013

    Nicola Cascavilla

    Recruiting

  • Policlinico Santa Maria alle Scotte

    Siena, SI, 53100

    Monica Bocchia

    Recruiting

  • AOU Città della Salute e della Scienza di Torino

    Torino, TO, 10126

    Ernesta Audisio, MD

    Recruiting

  • A.O. Ordine Mauriziano

    Torino, TO, 10128

    Alessandro Cignetti

    Recruiting

  • Ospedale Ca' Foncello

    Treviso, TV, 31100

    Michele Gottardi, MD

    Recruiting

Other trials in Italy

About this study

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

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.

Read the detailed 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.

Keywords
AML, BCL-2, anti BCL2 inhibitors, clinical practice
Medical subject headings
Leukemia, Myeloid, Acute

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 18 months

Secondary outcomes (11)

  1. 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

    Measured: 18 months

  2. 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.

    Measured: 18 months

  3. Complete Remission

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

    Measured: 18 months

  4. Complete Remission with incomplete hematologic recovery

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

    Measured: 18 months

  5. Minimal Residual Disease

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

    Measured: 18 months

  6. 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

    Measured: 18 months

  7. Collection of number of hospitalizations

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

    Measured: 18 months

  8. Collection of days of hospitalizations

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

    Measured: 18 months

  9. Collection of number of clinical visits per patient

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

    Measured: 18 months

  10. 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

    Measured: 18 months

  11. 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

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start23 Aug 2019
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04070807
Sponsor's protocol ID
IRST204.04
Acronym
AVALON
Status last verified
Apr 2020
First submitted
23 Aug 2019
Last updated
21 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myeloid Leukemia, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 20 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bernadette Verogen, DR (+390544286058, cc.ubsc@irst.emr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events of grade 3 and 4 (NCTCAE version 5.0) (time frame: up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04070807.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.

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