Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05431257

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

Led by Rigshospitalet, Denmark · Updated on 2022-06-24

117

Participants Needed

1

Research Sites

483 weeks

Total Duration

On this page

Sponsors

R

Rigshospitalet, Denmark

Lead Sponsor

H

Helse Stavanger HF

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent is provided.
  • Diagnosis of de novo or secondary AML unfit for standard induction therapy, or relapsed/refractory AML after at least one prior therapy (excluding acute promyelocytic leukemia).
  • Agreement to participate in exploratory research including bio-banking and AML profiling.
  • ECOG performance status of 2 or less if aged 75 or older, or 3 or less if aged 18 to 74.
  • Leukocyte count less than 25 x10E9/l; hydroxyurea use permitted to meet this.
  • Adequate kidney function with creatinine clearance of 30 mL/min or higher.
  • Adequate liver function with ALT up to 4 times the upper limit of normal and bilirubin up to 1.5 times the upper limit.
  • Elderly/unfit AML patients must be 70 years or older, or aged 18 to 69 and ineligible for intensive chemotherapy due to comorbidities or other specified criteria.
  • Relapsed AML patients must be 55 years or older with non-CBF AML relapse, or 18 or older meeting criteria including ineligibility for intensive chemotherapy or relapse after prior therapies.
  • Refractory AML patients who failed to achieve remission after prior monotherapy or induction chemotherapy containing cytarabine or clofarabine plus a topoisomerase II inhibitor.
Not Eligible

You will not qualify if you...

  • Diagnosis of acute promyelocytic leukemia.
  • Fourth or higher AML relapse.
  • Leukemic blast content less than 10% in bone marrow or blood.
  • ECOG performance status higher than 3.
  • Prior venetoclax treatment for myeloid malignancy.
  • AML with central nervous system involvement.
  • HIV infection or uncontrolled hepatitis B or C infections.
  • Cardiovascular disability classified as New York Heart Association Class 2 or higher.
  • Significant medical conditions affecting participation, including chronic respiratory disease requiring oxygen, uncontrolled infections, malabsorption syndromes, or uncontrolled graft-versus-host disease.
  • Previous malignancies except those successfully treated or indolent at investigator discretion.
  • Pregnant or nursing women; women of childbearing potential must have a negative pregnancy test.
  • Fertile men or women of childbearing potential not using two reliable contraception methods.
  • Known allergy to venetoclax, azacitidine, or their components.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Hematology, Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

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Research Team

K

Kim Theilgaard-Mönch, MD, DMSc

CONTACT

A

Anne Louise Tølbøll Sørensen, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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