NCT04070807

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

20 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

1.3 years

First QC Date

August 23, 2019

Last Update Submit

April 20, 2020

Conditions

Acute Myeloid Leukemia

Keywords

AMLBCL-2anti BCL2 inhibitorsclinical practice

Outcome Measures

Primary Outcomes (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.

    up to 18 months

Secondary Outcomes (11)

  • Overall Survival

    18 months

  • Disease Free Survival (DFS)

    18 months

  • Complete Remission

    18 months

  • Complete Remission with incomplete hematologic recovery

    18 months

  • Minimal Residual Disease

    18 months

  • +6 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

ASST Cremona

Cremona, CR, 26100, Italy

RECRUITING

A.O. Pugliese Ciaccio

Catanzaro, CZ, 88100, Italy

RECRUITING

Irst Irccs

Meldola, FC, 47014, Italy

RECRUITING

AOU Careggi

Florence, FI, Italy

RECRUITING

IRCCS Casa Sollievo sofferenza

San Giovanni Rotondo, Foggia, 71013, Italy

RECRUITING

Ospedale F. Spaziani

Frosinone, FR, 03100, Italy

RECRUITING

P.O. Vito Fazzi

Lecce, LE, 73100, Italy

RECRUITING

Ospedale Santa Maria Goretti

Latina, LT, 04100, Italy

RECRUITING

Asst Monza

Monza, MB, 20900, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, MI, 20162, Italy

RECRUITING

Ospedale S.Spirito - ASL Pescara

Pescara, PE, 65124, Italy

RECRUITING

Ospedale Santa Maria della Misericordia

Perugia, PG, 06156, Italy

RECRUITING

AOU San Giovanni di Dio e Ruggi D'Aragona

Salerno, SA, 84131, Italy

RECRUITING

Policlinico Santa Maria alle Scotte

Siena, SI, 53100, Italy

RECRUITING

AOU Città della Salute e della Scienza di Torino

Torino, TO, 10126, Italy

RECRUITING

A.O. Ordine Mauriziano

Torino, TO, 10128, Italy

RECRUITING

Ospedale Ca' Foncello

Treviso, TV, 31100, Italy

RECRUITING

European Institute of Oncology

Milan, Italy

RECRUITING

Fondazione IRCCS Ca' Granda OSPEDALE MAGGIORE POLICLINICO

Milan, Italy

NOT YET RECRUITING

Ospedale Roma S.Eugenio

Roma, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Giovanni Martinelli, MD

    IRST IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernadette Verogen, DR

CONTACT

+390544286058cc.ubsc@irst.emr.it

Oriana Nanni

CONTACT

+390543739266oriana.nanni@irst.emr.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

August 23, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

April 21, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(20)