Clinical trial · Observational
Cancer-associated Gene Mutations in CML Treatment With TKIs by NGS
Integrative Genomic Analysis Reveals Cancer-associated Gene Mutations in Chronic Myeloid Leukemia Patients With Tyrosine Kinase Inhibitor Resistance or Intolerance
NCT04274231CI-TRIAL-00057722unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
We performed targeted-capture sequencing of 127 known and putative cancer-related genes of patients who best effect to TKIs ,or intolerance to TKIs,or resistance to TKIs by next-generation sequencing (NGS) .
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 |
|---|---|---|---|
| Different Gene Between Different TKIs Effection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| different effection | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- TKI best effect group
- description
- TKI best effect was defined achieve complete cytogenetic response (CCyR)after 3 months of treatment and the level of BCR/ABL\<10% after 3 months of treatment,the level of BCR/ABL\<1% .
- interventionNames
- Genetic: different effection
- label
- TKI resistance group
- description
- TKI resistance was defined as the lack of a complete hematologic response (CHR) after 3 months of TKI treatment, the lack of any cytogenetic response after 6 months of treatment, the lack of major cytogenetic response (MCyR) (Ph-positive cells \> 35%) after 12 months of treatment, an increase of white blood cell (WBC) count in at least two consecutive samplings (with a doubling of the count from the nadir to ≥ 20×109/L or an absolute increase of ≥ 50×109/L), or a relapse after a CHR or MCyR.
- interventionNames
- Genetic: different effection
- label
- TKI intolerance group
- description
- TKI intolerance was defined as at least grade 3 nonhematologic toxicity or grade 4 hematologic toxicity persisting for more than 7 days, related to TKIs at any dose.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Chronic myeloid leukemia-Chronic phase(CML-CP) patients treated with receiveTyrosine kinase inhibitor -TKI(including imatinib, dasatinib and nilotinib) for more than 1 years 2. best effect to TKIs ,or intolerance to TKIs,or resistance to TKIs according to Q-pcr detected BCR/ABL(IS) in peripheral blood and hematologic response and cytogenetic response 3. Informed consent of the patient or his legal representative Exclusion Criteria: 1. Patients had history of CML-AP or CML-BC 2. CML Patients who have received allogeneic hematopoietic stem cell transplantation 3. CML Patients who have received immunotherapy (except interferon, including car-t and other cellular immunotherapy) 4. Woman who is pregnant or nursing
References
Publications (0)
Data not yet available
No reference posted for this study.