Drug-screening in AML at Relapse for Targeted Treatment — DARTT-1  

AML Clinical Trial

Official title: Drug-screening in AML at Relapse for Targeted Treatment

Status Recruiting

Clinical Trial Summary

This is a non-randomised clinical study investigating subsequent patients with specific AML treatment started between January 1, 2022 until December 31, 2022.

Patients with relapsing disease are planned to be analyzed in this study

Clinical Trial Description

The standard treatment for young fit patients with acute myeloid leukemia (AML) is intensive chemotherapy followed by consolidation treatment with curative intent. Usually, two cycles of intensive chemotherapy are given, with subsequent consolidation treatment depending on the genetic risk-assessment of the patients as well as on the response to the induction treatment.

For elderly or unfit patients, such an intensive approach is not feasible, and palliative treatment must be considered. The standard first-line-treatment for such patients since more than a decade comprises repetitive cycles of a hypomethylating agent (either Azacitidine or Decitabine). The median progression free survival following these approaches in this population is between 4 and 8 months, with an overall-survival of up to 12 months. More recently, the addition of the Bcl-2 inhibitor Venetoclax to hypomethylating agents has led to a modest improvement both of progression-free and overall survival. However, overall survival in such patients usually does not exceed 14-16 months.

The laboratory of Prof. Berend Snijder, Institute of Molecular Systems Biology, at the ETH (Eidgenössische Technische Hochschule) Zurich has developed an image-based ex-vivo drug screening platform for patients with aggressive haematological malignancies, also called pharmacoscopy. Using such a technique, leukemic cells from a patient at relapse can be rapidly screened for sensitivity to single compounds. A drug score is calculated for each compound.

Starting in Q2/2021, the investigator at the Department of Medical Oncology, University Hospital Inselspital in Bern, collected experiences using such an approach. Having received information from the laboratory on top sensitivity of leukemic cells of a given patient to a specific drug, a process is initiated to try to obtain access to such off-label drugs. ;

Related Conditions & MeSH terms

• AML
• Recurrence

• NCT number: NCT05732688
• Study type: Interventional
• Source: University Hospital Inselspital, Berne
• Contact: Thomas Pabst, Prof Dr. med
• Phone: +41 31 632 84 30
• Email: thomas.pabst@insel.ch
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Completion date: June 2024