Withdrawal or Reduction TKIs in CML-CP
A Multicenter, Open-access Study of CML-CP Patients Treated With Effective TKIs at Least 5 Years and MR4.5(BCR/ABLIS<0.0032%) Maintenance More Than 18 Months Who Treatment With Half TKIs or Discontinue
1 other identifier
observational
100
1 country
1
Brief Summary
Compare MMR on 12 month treated with half TKIs(including imatinib, dasatinib, and nilotinib) or TKIs withdrawal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 23, 2019
CompletedFirst Submitted
Initial submission to the registry
October 26, 2019
CompletedFirst Posted
Study publicly available on registry
October 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedSeptember 5, 2021
September 1, 2021
2 years
October 26, 2019
September 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
MMR(BCR/ABL IS<0.01) on 12 moth
Half dose TKIs or discontinue TKIs treatment
12 moth
Study Arms (2)
Withdrawal TKIs
halve TKIs
Interventions
Eligibility Criteria
Diagnosed CML chronic phase,Age 18-70 years old,gender is not limited
You may qualify if:
- Age 18-70 years old, gender is not limited;
- Diagnosed CML chronic phase and effective TKI(including imatinib, dasatinib, and nilotinib) was continued for more than 5 years
- Q-PCR monitored BCR/ABLIS duration \< 0.0032% in the last 18 months
- Informed consent of the patient or his legal representative
You may not qualify if:
- Patients had history of CML-AP or CML-BC
- CML patients with previous or current ABL kinase mutations
- CML Patients who have received allogeneic hematopoietic stem cell transplantation
- CML Patients who have received immunotherapy (except interferon, including car-t and other cellular immunotherapy)
- Woman who is pregnant or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NanfangH
Guangzhou, Guangdong, 510515, China
Related Publications (1)
Luo J, Du X, Lou J, Wu J, Ma L, Huang J, Wang L, Tu C, Liu Z, Chen L, Tan Y, Luo D, Liang H, Yin C, Cao R, Zhou X, Liu Q, Liu X, Xu N. De-escalation or discontinuation of tyrosine kinase inhibitor in patients with chronic myeloid leukemia: A multicentral, open-label, prospective trial in China. EJHaem. 2022 Sep 19;3(4):1220-1230. doi: 10.1002/jha2.550. eCollection 2022 Nov.
PMID: 36467815DERIVED
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate chief physician
Study Record Dates
First Submitted
October 26, 2019
First Posted
October 29, 2019
Study Start
October 23, 2019
Primary Completion
October 31, 2021
Study Completion
December 31, 2021
Last Updated
September 5, 2021
Record last verified: 2021-09