PHASE II STUDY OF AZACITIDINE IN COMBINATION WITH LOW DOSE INTENSITY VENETOCLAX IN PATIENTS WITH ACUTE MYELOID LEUKEMIAWITH INTEGRATION OF EXPLORATIVE MULTI-OMICS AND EX VIVO DRUG SCREENING DATA - NAMLG-001 LD-VenEx

Rigshospitalet0 sites117 target enrollmentJuly 15, 2021

Overview

No summary available.

Registry

who.int

Start Date

July 15, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Written informed consent.
•2\. Patients who present with one of the following (except acute promyelocytic leukemia).
•a. De novo or secondary AML unfit for standard induction therapy (see below).
•b. Relapsed/refractory AML (2022 ELN response criteria) after at 1\-3 lines of prior therapies (see below).
•3\. Written informed consent to participate in the exploratory research program including biobanking, AML profiling, and ex vivo drug sensitivity testing to assess venetoclax and other drug sensitivities. (Not applicable for patients enrolled in Sweden)
•a. All patients are treated with azacytidine\+venetoclax irrespective of the ex vivo screening results.
•4\. ECOG Performance Status \= 2 for patients \= 75 years of age OR \= 3 for patients \= 18 to 74 years of age.
•5\. Leukocyte count \< 25 x10E9/l. Hydroxyurea use is permitted to meet this criterion.
•6\. Adequate renal function as demonstrated by a calculated creatinine clearance \= 30 mL/min; determined by the Cockcroft Gault formula.
•7\. Adequate liver function as demonstrated by

•1\.Acute promyelocytic leukemia (APL).
•2\. Patients with 4th or higher AML relapse.
•3\.Blast percentage in peripheral blood \< 10% (only applicable for patients in whom DSRT during screening is performed on blood).
•4\. ECOG Performance Status \>3 (see also inclusion criteria 4\).
•5\. Prior venetoclax treatment for myeloid malignancy.
•6\. Known CNS involvement with AML (note: CSF or radiological investigations are not required without clinical suspicion).
•7\. Known HIV infection or active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection that is not controlled with antiviral medication with the definition hereof at the discretion of the investigator.
•8\. Cardiovascular disability status of New York Heart Association Class \= 2\. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in palpitations, fatigue, dyspnea, or anginal pain.
•9\. Evidence of clinically significant condition(s), which at the investigator's discretion would adversely affect the patient's participation in this study (including but not limited to):
•a. Chronic respiratory disease that requires continuous oxygen use.