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Screening of IDH1 and IDH2 Gene Mutations in Adult Acute Myeloid Leukemia for Possible Targeted Therapy

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ClinicalTrials.gov Identifier: NCT03499912
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
  1. To assess the incidence of IDH1 and IDH2 mutations in adult AML patients, and to explore their associations with the patients' clinical, cytogenetic, and molecular characteristics as well as with treatment response and outcome.
  2. To delineate the similarities and distinctions among mutations at IDH1-R132, IDH2-R140 and IDH2-R172 in AML, both clinically and molecularly (including cytogenetics, immunophenotyping, mutation co-occurrence patterns).
  3. The results can be references for future selection of targeted therapy (targeting IDH mutant proteins).

Condition or disease
Acute Myeloid Leukemia

Detailed Description:

Isocitrate dehydrogenases (IDH) are enzymes that catalyze oxidative decarboxylation of isocitrate into alpha-ketoglutarate (α-KG). IDH1 and IDH2 mutations in AML give the enzymes neomorphic enzymatic activity to transform α-KG to D-2HG, an oncometabolite which acts as a competitive inhibitor of dioxygenases, and causes dysregulation of TET2 and histone demethylases, consequently leading to epigenetic reprogramming of a cell, blocking differentiation and contributing to a transformed phenotype, and leukemogenesis. Investigators plan to recruit 300 adult AML patients (newly diagnosed or relapsed). 10mL of peripheral blood or marrow blood will be obtained from routine practice blood/marrow sampling specimens (no extra venipuncture or bone marrow aspiration would be required) and sent for routine tests such as cytogenetics, immunophenotyping, and gene mutation analyses. IDH1 R132, IDH2 R140, and IDH2 R172 mutations will be screened by PCR followed by Sanger sequencing, as previously described.

Investigators will first assess the incidence of IDH1 and IDH2 mutations in adult AML patients, and then explore their associations with the patients' clinical course, cytogenetic, and molecular characteristics as well as with treatment response and outcome. Investigators also seek to delineate the similarities and distinctions among IDH mutation variants at IDH1-R132, IDH2-R140 and IDH2-R172, both clinically and molecularly (including cytogenetics, immunophenotyping, mutation co-occurrence patterns).


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Screening of IDH1 and IDH2 Gene Mutations in Adult Acute Myeloid Leukemia for Possible Targeted Therapy
Actual Study Start Date : March 29, 2017
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : July 1, 2019





Primary Outcome Measures :
  1. Incidence of IDH1 and IDH2 mutation [ Time Frame: 2017/03/07 - 2019/03/01 ]
    Peripheral blood or marrow blood will be obtained from routine practice blood/marrow sampling specimens (no extra venipuncture or bone marrow aspiration would be required) and sent for routine tests such as cytogenetics, immunophenotyping, and gene mutation analyses.



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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult AML patients (newly diagnosed or relapsed) diagnosed at the National Taiwan University Hospital (NTUH) according to the updated 2016 WHO AML classification criteria.
Criteria

Inclusion criteria:

  1. Patients ≥20 Years with Diagnosed Acute Myeloid Leukemia
  2. Willing to provide voluntary written informed consent before study related procedures

Exclusion criteria:

  1. Not acute myeloid leukemia patients
  2. Patients <20 Years with Diagnosed Acute Myeloid Leukemia

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): NCT03499912


Contacts
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Contact: Wen-Chien Chou 0972651701 wchou@ntu.edu.tw
Contact: Ming-Kai Chuang 0972652258 mingkai@ntuh.gov.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Wen-Chien Chou    0972651701    wchou@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Wen-Chien Chou National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03499912     History of Changes
Other Study ID Numbers: 201701030RIPC
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: March 2018

Keywords provided by National Taiwan University Hospital:
Acute myeloid leukemia
IDH1
IDH2
Genetic mutations
Prognosis

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