Precision Therapy Versus Standard Therapy in AML and MDS in Elderly

PHASE2RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

June 22, 2021

Primary Completion Date

June 10, 2026

Study Completion Date

June 10, 2027

Conditions
AML, AdultMDS
Interventions
DRUG

Standard therapy

"For AML patients: Venetoclax will be administered orally once daily Days 1 through 28, of a 28-day cycle, with a designated dose of 400 mg daily after ramp up in Cycle 1. During Cycle 1 Days 1 - 3, the dose of Venetoclax will ramp up from 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Day 3. Azacitidine (100 mg/m2) is given once daily following administration of venetoclax for 5 days of every cycle, starting on Day 1 of each cycle.~For MDS patients: Azacitidine (100 mg/m2) is given once daily for 5 days of every 28 day cycle, starting on day 1 of each cycle."

DRUG

Precision therapy

Precision therapy for both AML and MDS patients is standard therapy + tumor board determined precision therapy. The tumor board determined precision therapy can be all available drugs with a marketing authorization in Norway.

Trial Locations (1)

Unknown

RECRUITING

Akershus Universitetssykehus, Lørenskog

All Listed Sponsors
lead

University Hospital, Akershus

OTHER