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

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ClinicalTrials.gov Identifier: NCT03549351
Recruitment Status : Not yet recruiting
First Posted : June 8, 2018
Last Update Posted : October 18, 2018
Sponsor:
Collaborators:
University Hospital Dresden
German Cancer Research Center
Information provided by (Responsible Party):
Prof. Dr. Richard F Schlenk, University Hospital Heidelberg

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

Condition or disease Intervention/treatment
Leukemia, Myeloid, Acute Other: Measurable residual disease measured by flow cytometry

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Measurable Residual Disease in Intensively Treated Patients With Acute Myeloid Leukemia (AML) as Surrogate Endpoint for Survival
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2026



Intervention Details:
  • Other: Measurable residual disease measured by flow cytometry
    Measurable residual disease measured by flow cytometry


Primary Outcome Measures :
  1. Correlation between Measurable Residual Disease (MRD) and Survival with respect to treatment effects [ Time Frame: after 3 and 6 years ]

    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.



Biospecimen Retention:   None Retained
Blood Samples


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549351


Contacts
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Contact: Richard F Schlenk, Prof. Dr. +49 6221/56 ext 6228 Richard.schlenk@nct-heidelberg.de
Contact: Christoph Röllig, Dr. +49 731/500 ext 45501 sal@uniklinikum-dresden.de

Sponsors and Collaborators
University Hospital Heidelberg
University Hospital Dresden
German Cancer Research Center
Investigators
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Principal Investigator: Richard F Schlenk, Prof. Dr. University Hospital Heidelberg
  Study Documents (Full-Text)

Documents provided by Prof. Dr. Richard F Schlenk, University Hospital Heidelberg:

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Responsible Party: Prof. Dr. Richard F Schlenk, Head of NCT trials center, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT03549351     History of Changes
Other Study ID Numbers: NCT-2018-0554
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dr. Richard F Schlenk, University Hospital Heidelberg:
Leukemia, Myeloid, Acute
measurable residual disease
surrogate endpoint
multiparameter flow cytometry

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms