TKI Discontinuation in CML Patients of China

NCT03251352 | Unknown

• 1 other identifier: 201733572018022
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to describe the maintenance of the molecular remission after tyrosine kinase inhibitor (TKI) disconnection in chronic myeloid leukaemia (CML) patients in China in the real-world clinical practice setting. This is a post-marketing, non-interventional, single-arm, prospective registry study in adult patients with chronic phase (CP) and accelerated phase (AP) in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be undertaking TKI discontinuation under the conditions of informed consent and frequent monitoring according to the clinical guideline.

Conditions

Leukemia; Myelogenous; Chronic; BCR-ABL (Breakpoint Cluster Region-abelson Murine Leukemia); Positive

Keywords

TKI, CML, discontinuation

Outcome Measures

Primary Outcomes (1)

• Molecular Remission Rate

  The molecular remission rate

  at 12 months

Secondary Outcomes (3)

• Adverse Events

  through study completion, an average of 1 year

• Recurrence

  through study completion, an average of 1 year

• QoL

  through study completion, an average of 1 year

Study Arms (1)

TKI Discontinuation Group

The enrolled patients will be undertaking TKI discontinuation under the conditions of informed consent and frequent monitoring according to the clinical guideline.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The targeted population is CML patients under TKI treatment in China.

You may qualify if:

• Adults with CML-CP/AP and willingness of TKI discontinuation;
• With ≥ 5 years frontline imatinib, reached MMR (major molecular response) in 2 years, with ≥ 2 years MR (molecular response) 4.5;
• Reached MMR with frontline imatinib, with ≥ 2 years nilotinib, with ≥ 1 year MR4.5;
• Failure with frontline imatinib, reached MMR in 1 year with nilotinib, with ≥ 2 years MR4.5;
• With ≥ 3 years frontline imatinib, reached MMR in 1 year, with ≥ 2 years MR4.5.

You may not qualify if:

• Diagnosed with CML-BP before TKI treatment;
• With a TKI discontinuation of over 30 days in the first year;
• With a TKI discontinuation of over 30days on average annually;
• Reduced the dosage of TKI treatment without instructions;
• Transferred to the second-generation TKIs after resistance to imatinib.
• Under the treatment of stem cells transplantation

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead

Study Sites (1)

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518035, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Leukemia; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: August 16, 2017
• Study Start: March 1, 2017
• Primary Completion: September 30, 2022
• Study Completion: October 30, 2022
• Last Updated: March 16, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)