Cancer-associated Gene Mutations in CML Treatment With TKIs by NGS

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Different Gene Between Different TKIs Effection

Treatments: Genetic: different effection

Study type: Observational

Funder types: Other

Identifiers

NCT04274231

CML-NGS

Details and patient eligibility

About

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) .

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 3 patient groups

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% .

Treatment:

Genetic: different effection

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.

Treatment:

Genetic: different effection

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.

Treatment:

Genetic: different effection