Pharmacoscopy-guided Clinical Standard-of-care in r/r AML

Phase 2

Recruiting

• Conditions: AML, Adult
• Interventions: Diagnostic Test: Pharmacoscopy; Drug: Clinical standard-of-care (physician's choice)

• Registration Number: NCT06138990
• Lead Sponsor: ETH Zurich

Brief Summary

With an overall survival of below 12 months, the outcome of relapsed/refractory AML (RR AML) is poor, making it a critical challenge to identify effective therapies at this stage. The RAPID-01 trial aims to show for the first time in a randomized and controlled clinical trial that Pharmacoscopy (PCY), a functional precision medicine platform, helps improve clinical standard-of-care treatment selection for patients suffering from relapsed/refractory AML.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-18
• Status Verified: 2024-09
• Study Start: 2024-09-02
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm: Pharmacoscopy-guided clinical standard-of-care	Pharmacoscopy	Patients in the PCY-guided treatment arm will receive one of the clinical standard-of-care treatments suggested by their own PCY results, and confirmed by the treating physician.
Control arm	Clinical standard-of-care (physician's choice)	Patients in the control arm will be treated with clinical standard-of-care therapy for RR AML selected by the physician (physician's choice).

Primary Outcome Measures

Name	Time	Method
Complete response (CR) rate at day 28	day 28

Secondary Outcome Measures

Name	Time	Method
Composite response rate (CR+CRh+CRi) at day 28	day 28
Rate of patients bridged to allogeneic hematopoietic stem cell transplantation within 3 months post-treatment initiation	3 months
Treatment-related mortality within 3 months post-treatment initiation	3 months

Trial Locations

Locations (2)

Inselspital Bern; 🇨🇭 Bern, Switzerland

University Hospital Zurich; 🇨🇭 Zurich, Switzerland