Hypomethylating Agents and Venetoclax in Newly Diagnosed Acute Myeloid Leukemia Patients Not Eligible for Intensive Chemotherapy

September 14, 2020 updated by: Francesco Zaja, Ospedale Maggiore Di Trieste

Retrospective, Observational, Monocentric Study to Assess Efficacy and Safety of the Combination of an Hypomethylating Agent in Combination With Venetoclax for Newly Diagnosed Acute Myeloid Leukemia Patients Not Eligible for Intensive Chemotherapy

This is a retrospective, observational, monocentric study to evaluate the efficacy and safety of the combination of an hypomethylating agent with venetoclax newly diagnosed patients with acute myeloid leukemia ineligible for intensive chemotherapy

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The prognosis of acute myeloid leukemia (AML) patients who are ineligible for intensive chemotherapy is poor (Kantarjian et al). Hypomethylating agents, azacitidine and decitabine, are effective and less toxic regimens, and treatment with these agents has improved the prognosis of these patients (Fenaux et al).

Venetoclax, a Bcl-2 inhibitor, in combination with azacitidine has shown efficacy in AML patients with complete remission rate of 73% and overall survival at 2 years of 40-50% (Di Nardo et al).

On these grounds, the aim of this study is to collect the real-life experience with this combination in previously untreated AML patients.

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Trieste, Italy, 34100
        • Recruiting
        • SC Ematologia Ospedale Maggiore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population includes adult patients with newly diagnosed acute myeloid leukemia not eligible for intensive chemotherapy, treated in a referral center for hematology

Description

Inclusion Criteria:

  • age ≥18 years
  • newly diagnosed acute myeloid leukemia not eligible for intensive chemotherapy

Exclusion Criteria:

  • promyelocytic acute myeloid leukemia
  • patients who have already received one or more prior lines of therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
treated patients
hypomethylating agent (azacitidine or decitabine) in combination with venetoclax
Drug: Venetoclax
treatment with azacitidine or decitabine in combination with venetoclax
Other Names:
  • Decitabine
  • Azacitidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response (CR) rate
Time Frame: every three months after started treatment up to two years
according to European Leukemia Network (ELN)
every three months after started treatment up to two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: every three months after started treatment up to two years
according to European Leukemia Network (ELN)
every three months after started treatment up to two years
Morphologic leukemia-free state (MLFS)
Time Frame: every three months after started treatment up to two years
according to European Leukemia Network (ELN)
every three months after started treatment up to two years
Progression-free-survival
Time Frame: from the start of the treatment until the date of documented progression or date of death from any cause, assessed up to 2 years
from start of the treatment to progression or death
from the start of the treatment until the date of documented progression or date of death from any cause, assessed up to 2 years
Overall survival
Time Frame: from the start of the treatment until the date of documented progression or date of death from any cause, assessed up to 2 years
from start of the treatment to progression or death
from the start of the treatment until the date of documented progression or date of death from any cause, assessed up to 2 years
adverse events and serious adverse events
Time Frame: through study completion, for an average of 1 year
according to CTCAE v. 4.0
through study completion, for an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Maggiore Di Trieste

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2020

Primary Completion (ANTICIPATED)

September 16, 2020

Study Completion (ANTICIPATED)

September 30, 2020

Study Registration Dates

First Submitted

June 24, 2020

First Submitted That Met QC Criteria

June 27, 2020

First Posted (ACTUAL)

July 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMA-V

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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