Actively Recruiting
Precision Therapy Versus Standard Therapy in AML and MDS in Elderly
Led by University Hospital, Akershus · Updated on 2021-08-27
36
Participants Needed
1
Research Sites
311 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Precision Therapy Versus Standard Therapy in AML and MDS in Elderly
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of AML or related precursor neoplasms per WHO 2016 (excluding acute promyelocytic leukemia), or acute leukemias of ambiguous lineage, or high-risk MDS with IPSS-R > 4.5.1
- Age 60 years or older
- Not eligible for intensive chemotherapy or allogeneic stem cell therapy
- White blood cell count ≤ 25 x 10^9/L (hydroxyurea allowed for up to 14 days before treatment)
- Adequate kidney and liver function unless disease-related
- WHO performance status 0-2 if age ≥ 75 years, or 0-3 if age 60-74 years
- Life expectancy over 3 months
- Signed informed consent
- Male participants who are sexually active must agree to use condoms and avoid sperm donation from study start until 90 days after last treatment dose
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- AML with favorable genetics in patients fit for intensive chemotherapy
- Prior treatment for AML or MDS including investigational agents
- Inability to obtain bone marrow sample for NGS (dry tap)
- Previous or concurrent cancer unless successfully treated with curative intent at least 6 months prior
- Blast crisis of chronic myeloid leukemia
- Severe or uncontrolled medical conditions (e.g., uncontrolled diabetes, infections, hypertension, lung disease)
- Cardiac dysfunction including unstable angina, NYHA class ≥ 2, or unstable arrhythmias
- History of non-compliance with medical regimens or unreliable for follow-up
- Senile dementia, mental impairment, or psychiatric disorder preventing informed consent
- Inability to understand written informed consent
- Current chemotherapy, radiation, or immunotherapy other than hydroxyurea
- Known HIV positive status
- Known hepatitis B or C infection unless viral load undetectable within 3 months
- AML patients who received strong/moderate CYP3A inducers within 7 days before venetoclax
- Malabsorption syndrome or conditions preventing oral medication
- WHO performance status > 2 if ≥ 75 years, or > 3 if 60-74 years at randomization
- Progressive disease according to ELN criteria
- Eligibility for allogeneic stem cell transplantation after initial treatment
- Additional exclusion per targeted therapy drug guidelines
AI-Screening
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Trial Site Locations
Total: 1 location
1
Akershus Universitetssykehus
Lørenskog, Norway
Actively Recruiting
Research Team
A
Anders Erik Astrup Dahm, MD,PHD
CONTACT
A
Abrar Zaheer Quazi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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