Individualization of standard therapy for relapsed or insufficiently responding acute myeloid leukemia using a new technology called pharmacoscopy
Summary description of the study
In this study, we investigate whether standard treatments can be tailored to individual patients with recurrent/resistant acute myeloid leukemia (AML). Using a new technology called pharmacoscopy (PCY), we test the effect of various standard therapies on AML cells from patient blood or bone marrow samples. We aim to find out if PCY can improve therapy selection. Patients are randomly assigned to one of two groups. Half of the patients are assigned to the PCY group, while the other half are assigned to the control group. In the PCY group, the treatment decision is supported by PCY. In the control group, the treatment decision is made by the investigator. Thus, the treatment decision for the control group is not supported by PCY. The study protocol is the same in both groups. A total of five study visits will occur, lasting between 60 and 90 minutes each. At the beginning of the study, additional blood or bone marrow is collected for PCY. The individual study duration is three months. The total study duration is set at two years.
(BASEC)
Intervention under investigation
With PCY, there is the possibility to tailor the choice of therapy to an individual patient. In this study, the effect of standard AML therapies on patient cells is tested. PCY thus allows for the identification of effective therapies in vitro before they are applied to the patient. With this study, we aim to optimize the standard AML therapy for a specific patient.
(BASEC)
Disease under investigation
Recurrent/resistant acute myeloid leukemia
(BASEC)
- Patients with relapsed or refractory acute myeloid leukemia according to ELN 2022 criteria, suitable for intensive chemotherapy
- Successful PCY testing of samples
- Age: 18-70 years
(BASEC)
Exclusion criteria
- Acute promyelocytic leukemia
- Blast crisis after chronic myeloid leukemia
- PCY results cannot be awaited due to urgent therapy
(BASEC)
Trial sites
Basel, Bern, Zurich
(BASEC)
Sponsor
ETH Zürich
(BASEC)
Contact
Contact Person Switzerland
Alexandre Theocharides
+41 44 255 17 11
Alexandre.Theocharides@clutterusz.chUniversitätsspital Zürich Rämistrasse 100 CH-8091 Zürich
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
07.05.2024
(BASEC)
ICTRP Trial ID
NCT06138990 (ICTRP)
Official title (approved by ethics committee)
Pharmacoscopy-guided clinical standard-of-care in relapsed/refractory acute myeloid leukemia, a randomized phase-2 clinical trial (BASEC)
Academic title
Pharmacoscopy-guided Clinical Standard-of-care in Relapsed/Refractory Acute Myeloid Leukemia, a Randomized Phase-2 Clinical Trial (ICTRP)
Public title
Pharmacoscopy-guided Clinical Standard-of-care in r/r AML (ICTRP)
Disease under investigation
AML, Adult
(ICTRP)
Intervention under investigation
Diagnostic Test: PharmacoscopyDrug: Clinical standard-of-care (physician's choice)
(ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
(ICTRP)
Inclusion/Exclusion criteria
Inclusion criteria
- Patient with refractory or relapsed AML according to ELN2022 criteria.
- Age 18-70 years.
- Considered to be eligible for intensive chemotherapy.
- Written informed consent.
Exclusion criteria
- Acute promyelocytic leukemia (APL) with PML-RARA or one of the other pathognomonic variant fusion genes/chromosome translocations.
- Blast crisis after chronic myeloid leukemia (CML).
- Considered not eligible for intensive chemotherapy.
- Condition of the patient does not allow to wait for PCY results (patient requires immediate treatment).
- PCY not working / patient sample did not pass the QC steps of PCY.
- Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the principal investigator may interfere with the project or affect patient compliance.
- Legal incompetence or Subjects lacking capacity to provide informed consent.
- Participation in a clinical trial with an investigational drug within the 30 days preceding and during the present investigation.
(ICTRP)
not available
Primary and secondary end points
Complete response (CR) rate at day 28
(ICTRP)
Composite response rate (CR+CRh+CRi) at day 28;Rate of patients bridged to allogeneic hematopoietic stem cell transplantation within 3 months post-treatment initiation;Treatment-related mortality within 3 months post-treatment initiation
(ICTRP)
Registration date
14.11.2023 (ICTRP)
Incorporation of the first participant
not available
Secondary sponsors
University of Zurich;Insel Gruppe AG, University Hospital Bern (ICTRP)
Additional contacts
Alexandre Theocharides, MD PhD;Berend Snijder, PhD, bsnijder@ethz.ch, +41 44 633 71 49, University of Zurich, (ICTRP)
Secondary trial IDs
RAPID-01 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT06138990 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available