Withdrawal or Reduction TKIs in CML-CP

• Sponsor: Nanfang Hospital of Southern Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04143087
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 26.3
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

Compare MMR on 12 month treated with half TKIs(including imatinib, dasatinib, and nilotinib) or TKIs withdrawal.

Condition or Disease	Intervention/Treatment	Phase
MMR on 12 Month	Drug: withdrawal TKIs or halve TKIs

Detailed Description

1. Chronic myeloid leukemia-Chronic phase(CML-CP) patients treated with receive effective Tyrosine kinase inhibitor -TKI(including imatinib, dasatinib and nilotinib) for more than 5 years, and patients with BCR/ABLIS continuous negative in the last 18 months were randomly admitted to maintain the original effective TKI by half or stop taking .

2. Q-pcr detected BCR/ABLIS in peripheral blood once every month, once every two months after half a year, and continuously monitored for 12 months.

3. If the patients detected molecular recurrence (loss of MMR, BCR/ABLIS > 0.1%), the original dose of TKI should be administered again.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: 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
• Actual Study Start Date: Oct 23, 2019
• Anticipated Primary Completion Date: Oct 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Withdrawal TKIs	Drug: withdrawal TKIs or halve TKIs; Stop TKIs or treated by half TKIs
halve TKIs	Drug: withdrawal TKIs or halve TKIs; Stop TKIs or treated by half TKIs

Outcome Measures

Primary Outcome Measures

1. MMR(BCR/ABL IS<0.01) on 12 moth [12 moth]

   Half dose TKIs or discontinue TKIs treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age 18-70 years old, gender is not limited;

2. Diagnosed CML chronic phase and effective TKI(including imatinib, dasatinib, and nilotinib) was continued for more than 5 years

3. Q-PCR monitored BCR/ABLIS duration < 0.0032% in the last 18 months

4. Informed consent of the patient or his legal representative

Exclusion Criteria:

1. Patients had history of CML-AP or CML-BC

2. CML patients with previous or current ABL kinase mutations

3. CML Patients who have received allogeneic hematopoietic stem cell transplantation

4. CML Patients who have received immunotherapy (except interferon, including car-t and other cellular immunotherapy)

5. Woman who is pregnant or nursing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NanfangH	Guangzhou	Guangdong	China	510515

Sponsors and Collaborators

• Nanfang Hospital of Southern Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: xuna, Associate chief physician, Nanfang Hospital of Southern Medical University
• ClinicalTrials.gov Identifier: NCT04143087
• Other Study ID Numbers: TKIs-cml-002
• First Posted: Oct 29, 2019
• Last Update Posted: Sep 5, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Sep 5, 2021