Using Pharmacoscopy to improve treatment for relapsed/refractory AML
Pharmacoscopy-guided Clinical Standard-of-care in Relapsed/Refractory Acute Myeloid Leukemia, a Randomized Phase-2 Clinical Trial
PHASE2 · ETH Zurich · NCT06138990
This study is trying out a new method called Pharmacoscopy to see if it can help doctors choose better treatments for adults with relapsed or refractory acute myeloid leukemia.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | ETH Zurich (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Bern, Canton of Bern and 1 other locations) |
| Trial ID | NCT06138990 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Pharmacoscopy, a functional precision medicine platform, in guiding treatment decisions for patients with relapsed or refractory acute myeloid leukemia (AML). By comparing standard-of-care treatment selection with and without the use of Pharmacoscopy, the trial seeks to determine if this innovative approach can enhance patient outcomes. Eligible participants are adults aged 18-70 who are considered suitable for intensive chemotherapy and have provided informed consent. The study is designed as a randomized and controlled trial to provide robust evidence of the benefits of this method.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 with relapsed or refractory AML who are eligible for intensive chemotherapy.
Not a fit: Patients with acute promyelocytic leukemia or those not eligible for intensive chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and survival rates for patients with relapsed/refractory AML.
How similar studies have performed: While the use of Pharmacoscopy is a novel approach, similar functional precision medicine strategies have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full 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.
Where this trial is running
Bern, Canton of Bern and 1 other locations
- Inselspital Bern — Bern, Canton of Bern, Switzerland (RECRUITING)
- University Hospital Zurich — Zurich, Canton of Zurich, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Alexandre Theocharides, MD PhD — University of Zurich
- Study coordinator: Berend Snijder, PhD
- Email: bsnijder@ethz.ch
- Phone: +41 44 633 71 49
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: AML, Adult, relapsed / refractory AML, Pharmacoscopy, Functional precision medicine