An observational study in Leukemia, Myeloid, Acute, sponsored by University Hospital Heidelberg. Terminated at 1 site in Germany. Per ClinicalTrials.gov, last updated 2022-09-13.
Sponsored by University Hospital Heidelberg · Observational
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
Acute myeloid leukemia is a genetically and phenotypically heterogeneous disorder with an incidence of 3 to 4 per 100 000 men and women per year and a median age at diagnosis of about 70 years. Prognosis, especially in older patients, has remained very poor. In patients considered suitable for intensive chemotherapy, the combination of an anthracycline and cytarabine remains the standard of care. For patients achieving a complete remission (CR), postremission therapy (PRT) ranging from chemotherapy to allogeneic hematopoietic stem cell transplantation is required; intensive PRT is still under debate in older patients. Beyond pre-treatment genetics-based risk stratification, measurable residual disease (MRD) during treatment and follow up emerges as an important prognostic factor in first CR. Furthermore, MRD may provide a tool for a read-out of therapeutic efficacy. In this diagnostic meta-study the investigators intend to measure MRD using multiparameter flow cytometry across up-front randomized clinical trials which in total will accrue more than 1000 patients. According to the leukemia-associated phenotype at diagnosis or the different-from-normal approach, MRD will be assessed early (after induction) and late (after consolidation) during treatment. The aim of the study is to show that levels of MRD measured early during treatment are closely related to overall survival and thus may serve as an early surrogate. There is a growing public demand that new, promising drugs are approved for therapy as rapidly as possible. Therefore, it is of great interest to obtain these approvals based on early biomarker endpoints such as MRD rather than on long-term survival endpoints.
5,441 studies on the registry are indexed under Leukemia; 637 are open to participants now.
This study's enrollment of 51 is below the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →University Hospital Heidelberg is the lead sponsor of 175 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with AML participating in interventional prospective randomized trials of the Study Alliance Leukemia (SAL) including the Heidelberg Leukemia Network (HeLeNe)
Exclusion Criteria:
Measurable residual disease measured by flow cytometry
Correlation between Measurable Residual Disease (MRD) and Survival with respect to treatment effects
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.
Time frame: after 3 and 6 years
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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University Hospital Heidelberg