Evaluation of Measurable Residual Disease in Patients With Acute Myeloid Leukemia as Surrogate Endpoint for Survival

NCT03549351 | Terminated DMC

• 1 other identifier: NCT-2018-0554
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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

Leukemia, Myeloid, Acute

Keywords

Leukemia, Myeloid, Acute; measurable residual disease; surrogate endpoint; multiparameter flow cytometry

Outcome Measures

Primary Outcomes (1)

• 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.

  after 3 and 6 years

Interventions

Measurable residual disease measured by flow cytometry OTHER

Measurable residual disease measured by flow cytometry

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with AML participating in interventional prospective randomized trials of the Study Alliance Leukemia (SAL) including the Heidelberg Leukemia Network (HeLeNe)

You may qualify if:

• 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.

You may not qualify if:

• No signed informed consent compliant with the requirements of PERDAM

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• University Hospital Dresden: collaborator
• German Cancer Research Center: collaborator

Study Sites (1)

University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69124, Germany

Location

Biospecimen

Retention: NONE RETAINED

Blood Samples

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard F Schlenk, Prof. Dr.

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of NCT trials center

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: June 8, 2018
• Study Start: June 1, 2019
• Primary Completion: September 11, 2022
• Study Completion: September 11, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)