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

Acute Myeloid Leukemia, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04454580
• Other study ID #: HMA-V
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: September 2020
• Source: Ospedale Maggiore Di Trieste
• Contact: Francesco Zaja, Professor
• Phone: +390403992888
• Email: francesco.zaja[@]asugi.sanita.fvg.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 30, 2020
• Est. primary completion date: September 16, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia, Adult
• Hypomethylating Agents
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Venetoclax

Intervention

Drug:
• Venetoclax
treatment with azacitidine or decitabine in combination with venetoclax

Locations

Country	Name	City	State
Italy	SC Ematologia Ospedale Maggiore	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Maggiore Di Trieste

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

Döhner H, Estey E, Grimwade D, Amadori S, Appelbaum FR, Büchner 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, Löwenberg B, Bloomfield CD. Diagnosi — View Citation

Fenaux P, Mufti GJ, Hellström-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. — View Citation

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 leukem — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response (CR) rate	according to European Leukemia Network (ELN)	every three months after started treatment up to two years
Secondary	Overall response rate (ORR)	according to European Leukemia Network (ELN)	every three months after started treatment up to two years
Secondary	Morphologic leukemia-free state (MLFS)	according to European Leukemia Network (ELN)	every three months after started treatment up to two years
Secondary	Progression-free-survival	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
Secondary	Overall survival	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
Secondary	adverse events and serious adverse events	according to CTCAE v. 4.0	through study completion, for an average of 1 year