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

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) .

Study Overview

• Status: Recruiting
• Conditions: Different Gene Between Different TKIs Effection
• Intervention / Treatment: Genetic: different effection

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: xu na, doctor; Phone Number: 8618620698390; Email: sprenaa@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • NanfangH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Best effect to TKI group Intolerance to TKI group Resistance to TKI group

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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% .	Genetic: 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.	Genetic: 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.	Genetic: different effection; Analysis of the reasons for treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cancer-associated gene mutations in CML treatment with TKIs by NGS	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)	1 year after TKI treatment

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Investigators: Principal Investigator: H Nanfang, Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 16, 2020
• First Submitted That Met QC Criteria: February 16, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 9, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CML-NGS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No