Clinical trial · Observational
Evaluation of Measurable Residual Disease in Patients With Acute Myeloid Leukemia as Surrogate Endpoint for Survival
Prospective Evaluation of Measurable Residual Disease in Intensively Treated Patients With Acute Myeloid Leukemia (AML) as Surrogate Endpoint for Survival
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study turned out no longer feasible
Summary
Brief summary (as posted)
Objectives To demonstrate that measurable residual disease assessed by multiparameter flow cytometry during intensive treatment is a surrogate for overall survival and thus an early read-out for drug efficacy Study design Surrogate endpoint trial to establish that measurable residual disease assessed by multiparameter flow cytometry during intensive treatment is a surrogate for overall survival
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Measurable residual disease measured by flow cytometry | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Correlation between Measurable Residual Disease (MRD) and Survival with respect to treatment effects
- timeFrame
- after 3 and 6 years
- description
- MRD will be assessed using multiparameter flow cytometry early (after induction / salvage). Survival will be assessed continuously. After 3 and 6 years correlation between MRD and survival will be analysed with respect to treatment effects to assess if MRD may serve as surrogate endpoint. If levels of MRD measured early during treatment are closely related to overall survival and thus may serve as an early surrogate will be assessed yearly.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Acute myeloid leukemia according to the WHO classification * Informed consent in place for a randomized study of the Study Alliance Leukemia (SAL) including the Heidelberg Leukemia Network (HeLeNe) covering assessment of MRD by MPFC in the reference laboratories in Heidelberg and Dresden. Exclusion Criteria: * No signed informed consent compliant with the requirements of PERDAM
References
Publications (0)
Data not yet available