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

NCT04454580 | Unknown FDA Drug

• 1 other identifier: HMA-V
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Myeloid Leukemia, Adult; Hypomethylating Agents; Venetoclax

Outcome Measures

Primary Outcomes (1)

• Complete response (CR) rate

  according to European Leukemia Network (ELN)

  every three months after started treatment up to two years

Secondary Outcomes (5)

• Overall response rate (ORR)

  every three months after started treatment up to two years

• Morphologic leukemia-free state (MLFS)

  every three months after started treatment up to two years

• Progression-free-survival

  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

  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

  through study completion, for an average of 1 year

Study Arms (1)

treated patients

hypomethylating agent (azacitidine or decitabine) in combination with venetoclax

Drug: Venetoclax

Interventions

Venetoclax DRUG

treatment with azacitidine or decitabine in combination with venetoclax

Also known as: Azacitidine, Decitabine

treated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ospedale Maggiore Di Trieste: lead

Study Sites (1)

SC Ematologia Ospedale Maggiore

Trieste, 34100, Italy

RECRUITING

Related Publications (4)

• Fenaux P, Mufti GJ, Hellstrom-Lindberg E, Santini V, Gattermann N, Germing U, Sanz G, List AF, Gore S, Seymour JF, Dombret H, Backstrom J, Zimmerman L, McKenzie D, Beach CL, Silverman LR. Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia. J Clin Oncol. 2010 Feb 1;28(4):562-9. doi: 10.1200/JCO.2009.23.8329. Epub 2009 Dec 21.

  PMID: 20026804 BACKGROUND

• DiNardo CD, Pratz K, Pullarkat V, Jonas BA, Arellano M, Becker PS, Frankfurt O, Konopleva M, Wei AH, Kantarjian HM, Xu T, Hong WJ, Chyla B, Potluri J, Pollyea DA, Letai A. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. Blood. 2019 Jan 3;133(1):7-17. doi: 10.1182/blood-2018-08-868752. Epub 2018 Oct 25.

  PMID: 30361262 BACKGROUND

• Dohner H, Estey E, Grimwade D, Amadori S, Appelbaum FR, Buchner T, Dombret H, Ebert BL, Fenaux P, Larson RA, Levine RL, Lo-Coco F, Naoe T, Niederwieser D, Ossenkoppele GJ, Sanz M, Sierra J, Tallman MS, Tien HF, Wei AH, Lowenberg B, Bloomfield CD. Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel. Blood. 2017 Jan 26;129(4):424-447. doi: 10.1182/blood-2016-08-733196. Epub 2016 Nov 28.

  PMID: 27895058 RESULT

• Kantarjian H, Ravandi F, O'Brien S, Cortes J, Faderl S, Garcia-Manero G, Jabbour E, Wierda W, Kadia T, Pierce S, Shan J, Keating M, Freireich EJ. Intensive chemotherapy does not benefit most older patients (age 70 years or older) with acute myeloid leukemia. Blood. 2010 Nov 25;116(22):4422-9. doi: 10.1182/blood-2010-03-276485. Epub 2010 Jul 28.

  PMID: 20668231 RESULT

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; Azacitidine; Decitabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Francesco Zaja, Professor

  SC Ematologia Ospedale Maggiore Trieste

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Zaja, Professor

CONTACT

+390403992888; francesco.zaja@asugi.sanita.fvg.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 1, 2020
• Study Start: August 1, 2020
• Primary Completion: September 16, 2020
• Study Completion: September 30, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)