Precision Therapy Versus Standard Therapy in AML and MDS in Elderly

NCT05025098 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: PALM
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AML, Adult; MDS

Outcome Measures

Primary Outcomes (1)

• cost-effectiveness of a precision therapy

  To evaluate the cost-effectiveness of a precision therapy strategy compared with standard treatment. The total cost of the treatment will be calculated and divided on health related quality of life (HRQoL)

  4-5 years

Secondary Outcomes (16)

• Event free survival

  4-5 years

• Overall survival

  4-5 years

• Adverse events

  4-5 years

• Toxicity

  4-5 years

• Transfusion independence

  4-5 years

Study Arms (2)

Standard therapy

ACTIVE COMPARATOR

This study is a randomization between treatment principles, not treatments, i.e., standard therapy vs precision therapy (tumor board determined). Standard treatment for AML patients is Azacitidine + Venetoclax.\* \*Only if venetoclax is available to the study at the time-point of study start. If venetoclax is not available AML patients will receive Azacitidine alone similar to MDS patients. Standard treatment for MDS is Azacitidine.

Drug: Standard therapy

Precision therapy

EXPERIMENTAL

This study is a randomization between treatment principles, not treatments, i.e., standard therapy vs precision therapy (tumor board determined). The precision therapy arm will receive standard therapy + tumor board decided precision therapy. The tumor board decided precision therapy can in principle be any therapy with marketing authorization in Norway.

Drug: Standard therapy; Drug: Precision therapy

Interventions

Standard therapy DRUG

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.

Also known as: Azacitidine + venetoclax for AML patients. Azacitidine for MDS patients.

Precision therapy; Standard therapy

Precision therapy DRUG

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.

Also known as: Standard therapy + tumor board decided precision therapy drug.

Precision therapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of AML and related precursor neoplasms according to WHO 2016 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease and therapy-related AML (not if they have received antileukemic/mds treatment)), or
• acute leukemias of ambiguous lineage according to WHO 2016 or a diagnosis of myelodysplastic syndrome (MDS) with IPSS-R \> 4.5.1
• Patients 60 years and older.
• Patients must NOT be eligible for intensive chemotherapy or allogeneic stem cell therapy (See Chapter 23.3)
• WBC ≤ 25 x109/L (prior hydroxyurea allowed for a maximum of 14 days, stopped before start of treatment)
• Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values:
• WHO performance status 0, 1 or 2 for subjects ≥ 75 years of age OR 0 to 3 for subjects ≥ 60 to 74 years of age.
• Life-expectancy above 3 months
• Signed Informed Conscent
• Male Subjects Only: Male subjects who are sexually active, must agree, from Study Day 1 through at least 90 days after the last dose of study drug, to practice contraception with condom. Male subjects must agree to refrain from sperm donation from initial study drug administration until at least 90 days after the last dose of study drug.

You may not qualify if:

• Acute promyelocytic leukemia.
• AML with favourable cytogenetic or genetic changes in patients who are fit for intensive chemotherapy. Favourable genetics are: t(8;21)(q22;q22.1); RUNX1-RUNX1T1; inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11; mutated NPM1 without FLT3-ITD or with FLT3-ITDlow†; Biallelic mutated CEBPA
• Patients previously treated for AML or MDS (any antileukemic therapy or MDS treatment including investigational agents).
• Patients where it is not possible to get bone-marrow for NGS, i.e., "dry tap".
• Blast crisis of chronic myeloid leukemia.
• Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etc.)
• Cardiac dysfunction as defined by:
• Unstable angina or
• New York Heart Association Class ≥ 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue,palpitations, dyspnea, or angina pain or
• Unstable cardiac arrhythmias
• Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance with the study protocol and follow-up schedule.
• Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.
• Patients who do not understand the Written Informed Consent (e.g., language problems)
• Current concomitant chemotherapy, radiation therapy, or immunotherapy; other than hydroxyurea.
• Subject is known to be positive for HIV (HIV testing is not required).

Sponsors & Collaborators

• University Hospital, Akershus: lead

Study Sites (1)

Akershus Universitetssykehus

Lørenskog, Norway

RECRUITING

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MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Standard of Care; Azacitidine; venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Anders Erik Astrup Dahm, MD, PHD

  Akershus universitetssykehus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anders Erik Astrup Dahm, MD,PHD

CONTACT

+4793059809; aeadahm@gmail.com

Abrar Zaheer Quazi, MD

CONTACT

+4795911042; abrarq@hotmail.no

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: randomized open label clinical study phase II

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: August 27, 2021
• Study Start: June 22, 2021
• Primary Completion (Estimated): June 10, 2026
• Study Completion (Estimated): June 10, 2027
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)