Azacitidine in Combination With Low Dose Intensity Venetoclax in Patients With AML Incl. Explorative AML Profiling

Summary

Multi-center phase II study of standard azacytidine treatment (AZA; D1-D7, 75mg/m2 qd) in combination with a short duration of "low-dose" venetoclax treatment (LD-VEN; D1-D14 before CR and D1-D7 after CR, 400mg qd) per 28 days cycle for elderly/unfit (arm 1) and relapsed/refractory (arm 2) patients with acute myeloid leukemia.

AZA and LD-VEN treatment is combined with exploratory AML profiling using established platforms for OMICs analyses and ex vivo drug sensitivity and resistance testing. This will validate the feasibility of AML profiling in a clinical setting to predict responders and non-responders to AZA/LD-VEN therapy. The exploratory AML profiling program will also identify biomarkers as well as novel drugs and drug combinations applicable for treatment of AML patients in future clinical trial initiatives.

Conditions

• Acute Myeloid Leukemia

Interventions

DRUG

Venetoclax

Standard azacytidine treatment (AZA; D1-D7, 75mg/m2 qd) in combination with a short duration of "low-dose" venetoclax treatment (LD-VEN; D1-D14 before CR and D1-D7 after CR, 400mg qd) per 28 days cycle for elderly/unfit (arm 1) and relapsed/refractory (arm 2) patients with acute myeloid leukemia.

Sponsors & Collaborators

• Helse Stavanger HF

  collaborator OTHER_GOV

• University Hospital of North Norway

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• Vestre Viken Hospital Trust

  collaborator OTHER

• Helse Møre og Romsdal HF

  collaborator OTHER_GOV

• Karolinska University Hospital

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Uppsala University Hospital

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Oulu University Hospital

  collaborator OTHER

• Tampere University Hospital

  collaborator OTHER

• Kuopio University Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-24

Primary Completion

2031-09-01

Completion

2031-09-01

Countries

• Denmark

Study Locations