AMLDARTT-1NCT05732688
Drug-screening in AML at Relapse for Targeted Treatment
A study testing Image-based ex-vivo drug screening platform (pharmacoscopy) in people with AML, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML
- What is being tested?
- Image-based ex-vivo drug screening platform (pharmacoscopy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients able to undergo intensive reinduction treatment with subsequent allogeneic hematopoietic transplantation in a curative intent
- Patients have available standard therapeutic options
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Departement of Medical Oncology, University Hospital Berne
Bern, 3010
About this study
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
Read the detailed 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.
- Conditions
- AML
- Being tested
- Image-based ex-vivo drug screening platform (pharmacoscopy)
- Keywords
- AML, Relapse, Drug-screening, Pharmacoscopy
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-based ex-vivo drug screening platform (pharmacoscopy)Diagnostic test
Also called Pharmacoscopy
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".
| Study group | Role | What they receive |
|---|---|---|
| Pharmacoscopy | Experimental | Leukemic cells from a patient at relapse can be screened for sensitivity to single compounds Receives: Diagnostic Test: Image-based ex-vivo drug screening platform (pharmacoscopy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (6)
Identification of effective drug
Percentage of patients in which a promising drug can be identified using drug screening
Measured: 12 months
Duration of response
Duration of response of patients effectively treated with a drug identified by drug screening
Measured: 12 months
Overall survival
Overall survival of patients effectively being treated with a drug identified by drug screening.
Measured: 12 months
Response rate of patients depending on the RBF (relative blast fraction) value
Number of patients responding to their chosen therapy regimen in correlation to the RBF (relative blast fraction) value
Measured: 12 months
Duration of response of patients depending on the RBF (relative blast fraction) value
Duration of response in patients responding to their chosen therapy regimen in correlation to the RBF (relative blast fraction) value
Measured: 12 months
Overall survival of patients depending on the RBF (relative blast fraction) value
Overall survival of patients responding to their chosen therapy regimen in correlation to the RBF (relative blast fraction) value
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Jan 2022
- Primary completion1 Apr 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Pabst, Prof Dr. med, Study chair, Department for Medical Oncology; University Hospital/Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732688
- Sponsor's protocol ID
- DARTT-1
- Acronym
- DARTT-1
- Status last verified
- Jul 2024
- First submitted
- 7 Feb 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-screening in AML at Relapse for Targeted Treatment
- ClinicalTrials.gov ID
- NCT05732688
- Acronym / sponsor ID
- DARTT-1 / DARTT-1
- Conditions
- AML
- Keywords
- AML, Relapse, Drug-screening, Pharmacoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacoscopy | Experimental | Diagnostic Test: Image-based ex-vivo drug screening platform (pharmacoscopy)Leukemic cells from a patient at relapse can be screened for sensitivity to single compounds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients able to undergo intensive reinduction treatment with subsequent allogeneic hematopoietic transplantation in a curative intent
- Patients have available standard therapeutic options
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image-based ex-vivo drug screening platform (pharmacoscopy)Also: PharmacoscopyLeukemic 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". | Diagnostic test | Pharmacoscopy |
Primary outcome
Treatment with identified effective drug
Time frame: 12 months
Percentage of patients with relapsing AML in which drug screening identifies a promising effective drug and in which such a treatment effectively is started
6 secondary outcomes
Identification of effective drug
Time frame: 12 months
Duration of response
Time frame: 12 months
Overall survival
Time frame: 12 months
Response rate of patients depending on the RBF (relative blast fraction) value
Time frame: 12 months
Duration of response of patients depending on the RBF (relative blast fraction) value
Time frame: 12 months
Overall survival of patients depending on the RBF (relative blast fraction) value
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Pabst, Prof Dr. med study chair
Department for Medical Oncology; University Hospital/Inselspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image-based ex-vivo drug screening platform (pharmacoscopy) in people with AML, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment with identified effective drug (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.