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Precision Therapy Versus Standard Therapy in AML and MDS in Elderly

NCT05025098 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-08-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University Hospital, Akershus

    lead OTHER

Principal Investigators

  • Anders Erik Astrup Dahm, MD, PHD · Akershus universitetssykehus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-22
Primary Completion
2026-06-10
Completion
2027-06-10
FDA Drug
Yes

Countries

  • Norway

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05025098 on ClinicalTrials.gov