NCT03537560

Brief Summary

  1. 1.Detection of IDH2 mutations in AML patients to define it incidence and correlation with clinical characteristics, relapse-free and overall survival.
  2. 2.Identify AML patients who are potential candidates for IDH2 inhibitor treatment.
  3. 3.Monitoring minimal residual disease (MRD) following therapy to evaluate its possible role in the strategy of MRD-directed therapy in the future in patients carrying IDH2 mutations at initial diagnosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
334

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

6.4 years

First QC Date

May 15, 2018

Last Update Submit

August 29, 2023

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Detection of IDH2 mutations

    The mononuclear cells will be extracted from bone marrow samples at the initial diagnosis. The mutational analysis of exon 4 of IDH2 gene will be performed by PCR amplication followed by pyrosequencing to detect IDH2-R140 and R172 mutations and mutant levels.

    1 month

Secondary Outcomes (1)

  • Follow-up detection of IDH2 mutations

    24 months

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with AML newly diagnosed and followed in Chang Gung Memorial Hospital.

You may qualify if:

  • Patients diagnosed with AML, age ≥ 20 years, and are willing to sign the informed consent

You may not qualify if:

  • Not AML patients
  • Patients diagnosed with AML but age \< 20 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital-Linkou

Taoyuan District, State, 33305, Taiwan

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Lee-Yung Shih, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 15, 2018

First Posted

May 25, 2018

Study Start

March 1, 2017

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

August 31, 2023

Record last verified: 2023-08

Locations

TW(1)