A Study on the Withdrawal of Second-generation Tyrosine Kinase Inhibitors After Dose Reduction in Patients With CML

• Sponsor: xuna (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05341050
• Collaborator: (none)
• Enrollment: 260
• Locations: 2
• Anticipated Duration (Months): 50
• Patients Per Site: 130
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

patients with Ph+ CML-CP who have been treated with second-generation TKIs (nilotinib, dasatinib) for at least 3 years and maintains MMR for at least 2 years, continue to be treated with halved dose for 12 months, and then stop for 12 months.

Condition or Disease	Intervention/Treatment	Phase
MMR on 12 Month	Drug: TKI

Detailed Description

1.Patients with Ph+ CML-CP who have been treated with second-generation TKIs (nilotinib, dasatinib) for at least 3 years and maintains MMR for at least 2 years.

2。During the TKI reduction phase, the peripheral blood BCR/ABLIS was detected by Q-PCR every two months and continuously monitored for 12 months. In the TFR period, the peripheral blood BCR/ABLIS was detected once a month for the first 6 months; the peripheral blood BCR/ABLIS was detected once every two months for the next 6 months; after that, the peripheral blood BCR/ABLIS was detected once every three months.

3.If the patients detected molecular recurrence (loss of MMR, BCR/ABL IS>0.1%),the original dose of 2G-TKI should be administered

Study Design

• Study Type: Observational
• Anticipated Enrollment: 260 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: This Study is a Multicenter, Single-arm, Prospective Study to Evaluate the Efficacy and Safety of Drug Discontinuation After Dose Reduction in Ph+CML-CP Patients Threated With 2G-TKI.
• Actual Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: May 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
patients with Ph+ CML-CP	Drug: TKI; halve dose of 2G-TKI for 12 months and then withdrawal for 12 months

Outcome Measures

Primary Outcome Measures

1. MMR(BCR/ABL IS<0.1%) on 24 months [24 months]

   Continue to treat patients at half-dose for 12 months, then stop for 12 months

Secondary Outcome Measures

1. MRFS [24 months]

   Molecular relapse free survival in 24 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female over 18 years

2. Patients diagnosed as Ph+ (or Ph- but PCR-positive for BCR-ABL) CML-CP

3. Patients have received one of the second-generation TKIs (nilotinib, dasatinib) for at least 3 years

4. Patients have maintained MMR (BCR/ABL IS<0.1% or more) at least 2 years

5. in the past 24 months, at least three times recent molecular reactions have confirmed MMR

6. Patients have signed the informed consent

Exclusion Criteria:

1. patients with the presence or history of T315I mutation

2. patients with the presence of rare unquantifiable atypical transcripts

3. Patients with comorbid cardiovascular disease or a history of severe cardiovascular disease

4. patients have history of accelerated or blast phase, or suspected blast disease

5. patients have received allogeneic hematopoietic stem cell transplantation

6. patients have severe abnormal liver and kidney function (ALT > upper limit of normal, AST > 3 times normal upper line, glomerular filtration rate < 50%)

7. patients combined with other tumors or a history of other malignancies ECOG score>3

8. Two-line abnormality in the patient's blood routine examination

9. women is pregnant or nursing

Contacts and Locations

Locations

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

Sponsors and Collaborators

• xuna

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: NCT05341050
• Other Study ID Numbers: TKIs-cml
• First Posted: Apr 22, 2022
• Last Update Posted: Apr 22, 2022
• Last Verified: Apr 1, 2022

• 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 Apr 22, 2022