RecruitingPhase 2NCT05025098

Precision Therapy Versus Standard Therapy in AML and MDS in Elderly

Precision Therapy Versus Standard Therapy in Acute Myeloid Leukaemia and Myelodysplastic Syndrome in Elderly

Sponsor

University Hospital, Akershus

Enrollment

36 participants

Start Date

Jun 22, 2021

Study Type

INTERVENTIONAL

Conditions

MDS AML, Adult

Summary

This is a randomized clinical trial that randomizes between treatment principles. The study will investigate if precision therapy determined by a tumour board is better than standard treatment for acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) in elderly. The tumour board will decide the precision therapy based on identified genetic changes that can guide customized therapy. There are currently 40-50 targeted therapies approved for various cancers in Norway. The precision therapy will be given in addition to the standard treatment. The primary study objective will be to evaluate the cost-effectiveness of a precision therapy strategy compared with standard treatment. Other objectives will mesaure efficacy and satety of the treatment, and impact on life quality of the patients.

Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This trial compares personalized "precision therapy" (treatment matched to each patient's specific cancer markers) versus standard treatment for older adults with certain blood cancers — including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) — who are not strong enough for intensive chemotherapy. **You may be eligible if...** - You are 60 years or older - You have been diagnosed with AML or MDS with a high-risk score - You are not a candidate for intensive chemotherapy or bone marrow transplant - Your white blood cell count, kidney function, and liver function meet study requirements - Your life expectancy is more than 3 months **You may NOT be eligible if...** - You have a specific favorable type of leukemia (acute promyelocytic leukemia or AML with favorable genetics) and are fit for intensive chemo - Your disease is too advanced or lab values are outside acceptable ranges Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGStandard 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.

DRUGPrecision 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.