Cancer-associated Gene Mutations in CML Treatment With TKIs by NGS
NCT ID: NCT04274231
Last Updated: 2022-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2020-02-16
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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TKI best effect group
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% .
different effection
Analysis of the reasons for treatment
TKI resistance group
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.
different effection
Analysis of the reasons for treatment
TKI intolerance group
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.
different effection
Analysis of the reasons for treatment
Interventions
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different effection
Analysis of the reasons for treatment
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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xuna
doctor
Principal Investigators
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H Nanfang
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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NanfangH
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CML-NGS
Identifier Type: -
Identifier Source: org_study_id
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