National Longitudinal Cohort of Hematological Diseases-Large Granular Lymphocytic Leukemia

Recruiting

• Conditions: T-LGL Leukemia; NK-LGL Leukemia

• Registration Number: NCT07019766
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief Summary

Hematological diseases are disorders of the blood and hematopoietic organs. The current hematological cohorts are mostly based on single-center or multi-center cases, or cohorts with limited sample size in China. There is a lack of comprehensive and large-scale prospective cohort studies in hematology.

The objectives of this study are to investigate the incidence and risk factors of large granular lymphocytic leukemia (LGLL) and to analyze the treatment effectiveness, patient prognosis, and healthcare costs in China.

1. Analyze the demographic and clinical characteristics of patients with LGLL, including sex, age, disease severity, and other relevant factors.

2. Examine disease features of LGLL patients, such as biochemical and hematological indicators, LGL counts, clonality, bone marrow pathology, and cytogenetics

3. Assess treatment patterns and real-world effectiveness in LGLL patients.

4. Evaluate clinical outcomes, including hematologic response, relapse, and mortality

5. Investigate long-term prognosis, including post-discontinuation outcomes and health-related quality of life.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-28
• Study First Submitted QC: 2025-06-05
• Study First Posted: 2025-06-13
• Last Update Submitted: 2025-06-15
• Last Update Posted: 2025-06-17
• Primary Completion: 2070-12-31
• Study Completion: 2070-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 9999

Inclusion Criteria

• Subjects diagnosed with LGLL.
• Subjects treated at the Institute of Hematology and Blood Diseases Hospital from Jan 1, 2000.

Exclusion Criteria

• Subject unlikely to be available for long-term follow-up for any reason (e.g., inability to obtain follow-up data or presence of severe comorbidities).
• Subject with alcohol or drug dependence that may reduce their compliance with the study.
• Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hematologic response	Assessments will be conducted at baseline, 6 months, 12 months, and 24 months after treatment, as well as at study completion, with an average interval of approximately 1 year.	Hematologic response contains improvements in neutrophil count, hemoglobin level, and platelet count

Trial Locations

Locations (1)

Red Blood Cell Diseases Center and Regenerative Medicine Center; 🇨🇳 Tianjin, Tianjin, China