Clinical trial · Observational
The Mutation Profile and Prognosis in AML With IDH1/2 Mutation
The Mutation Profile and Prognosis in Acute Myeloid Leukemia With IDH1/2 Mutation
NCT07004816CI-TRIAL-00097406terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Adapted the plan
Summary
Brief summary (as posted)
Investigators have a prospective clinical cohort including 500 adult AML patients. And investigators have stored leukemia sample from these patients. In this program investigators will do mutation profile in these patients. Also, investigators will elucidate the incidence of IDH1/2 mutations in adult AML in China and elucidate the prognostic effect of IDH1/2 mutation in AML.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Uncover mutation profiles | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- AML patients
- description
- Uncover mutation profiles of newly-diagnosed AML patients
- interventionNames
- Other: Uncover mutation profiles
Primary outcomes (1)
- measure
- Incidence
- timeFrame
- Before treatment
- description
- Incidence is defined as the incidence of patients who carries IDH1/2 mutations
Secondary outcomes (2)
- measure
- Relapse-Free Survival(RFS)
- timeFrame
- Up to 3 years
- description
- RFS is defined as the time from the date of complete remission (CR) after entry in this trial until the date of documented relapse or death for subjects who achieve CR.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age of less than 60 years old; 2. Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes). 3. Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent. Exclusion Criteria: 1. Patients with other blood diseases(for example, haemophiliacs) are excluded. 2. With mutation of breakpoint cluster region-Abelson(BCR-ABL) fusion gene and in need of tyrosine kinase inhibitors therapy; 3. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients; 4. Had other malignant tumor in need of treatment; 5. Patients with other factors which were considered unsuitable to participate in the study by the investigators.
References
Publications (0)
Data not yet available
No reference posted for this study.