Drug-screening in AML at Relapse for Targeted Treatment

NCT05732688 | Completed

• 1 other identifier: DARTT-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

AML

Keywords

AML; Relapse; Drug-screening; Pharmacoscopy

Outcome Measures

Primary Outcomes (1)

• Treatment with identified effective drug

  Percentage of patients with relapsing AML in which drug screening identifies a promising effective drug and in which such a treatment effectively is started

  12 months

Secondary Outcomes (6)

• Identification of effective drug

  12 months

• Duration of response

  12 months

• Overall survival

  12 months

• Response rate of patients depending on the RBF (relative blast fraction) value

  12 months

• Duration of response of patients depending on the RBF (relative blast fraction) value

  12 months

Study Arms (1)

Pharmacoscopy

EXPERIMENTAL

Leukemic cells from a patient at relapse can be screened for sensitivity to single compounds

Diagnostic Test: Image-based ex-vivo drug screening platform (pharmacoscopy)

Interventions

Image-based ex-vivo drug screening platform (pharmacoscopy) DIAGNOSTIC_TEST

Leukemic cells from a patient at relapse can be screened for sensitivity to single compounds. A drug score is calculated for each compound (defined as 1 - (% target cells in drug treated conditions / % target cells under control condition)). If a drug kills all target cells specifically, the best possible score is "1". If the drug is killing all non-target cells, the score goes to negative infinite. If a drug kills both target and non-target cell populations equally, or does nothing, the score is "0".

Also known as: Pharmacoscopy

Pharmacoscopy

Eligibility Criteria

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

You may qualify if:

• Included are patients with AML at relapse treated at the Department of Medical Oncology at the University Hospital Inselspital in Bern.
• Patients are not planned to undergo intensive reinduction treatment with subsequent allogeneic hematopoietic transplantation in a curative intent.
• Patients have exhausted all standard therapeutic options and they must have no available licensed standard treatment for relapsed AML.
• Written informed consent

You may not qualify if:

• Patients able to undergo intensive reinduction treatment with subsequent allogeneic hematopoietic transplantation in a curative intent
• Patients have available standard therapeutic options

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Departement of Medical Oncology, University Hospital Berne

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Pabst, Prof Dr. med

  Department for Medical Oncology; University Hospital/Inselspital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 17, 2023
• Study Start: January 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)