National Longitudinal Cohort of Hematological Diseases-Large Granular Lymphocytic Leukemia

NCT07019766 | Recruiting

• 1 other identifier: IIT2025043
• Study Type: observational
• Target: 9,999
• Locations: 1 country
• Sites: 1

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. 1.Analyze the demographic and clinical characteristics of patients with LGLL, including sex, age, disease severity, and other relevant factors.
2. 2.Examine disease features of LGLL patients, such as biochemical and hematological indicators, LGL counts, clonality, bone marrow pathology, and cytogenetics
3. 3.Assess treatment patterns and real-world effectiveness in LGLL patients.
4. 4.Evaluate clinical outcomes, including hematologic response, relapse, and mortality
5. 5.Investigate long-term prognosis, including post-discontinuation outcomes and health-related quality of life.

Conditions

T-LGL Leukemia; NK-LGL Leukemia

Keywords

Treatment patterns; Hematologic response

Outcome Measures

Primary Outcomes (1)

• Hematologic response

  Hematologic response contains improvements in neutrophil count, hemoglobin level, and platelet count

  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.

Study Arms (1)

NICHE-LGLL

Patients who were diagnosed with LGLL in the investigating hospitals from Jan 1, 2000.

Other: A combined retrospective and prospective observational follow-up

Interventions

A combined retrospective and prospective observational follow-up OTHER

The NICHE-LGLL will collect basic information, diagnostic and treatment information, as well as health costs information of patients from medical records. The study will use questionnaire to measure the exposure of patients, and prospectively follow-up to collect the prognosis information.

NICHE-LGLL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pantients diagnosed as LGLL. Diagnostic criteria for LGLL (Large Granular Lymphocytic Leukemia): Increased number of circulating LGL cells (\>0.5×10\^9/L) identified based on complete blood count and/or a consistent immunophenotypic pattern; Evidence of clonality confirmed by flow cytometry and/or molecular biology techniques; In patients with a low LGL cell count, diagnosis can still be made if there is a characteristic immunophenotype, STAT3 mutation, or bone marrow pathology abnormalities.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Red Blood Cell Diseases Center and Regenerative Medicine Center

Tianjin, Tianjin Municipality, 301617, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Large Granular Lymphocytic

Condition Hierarchy (Ancestors)

Leukemia, T-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Lele Zhang, PhD

CONTACT

‭15811139278‬; zhanglele@ihcams.ac.cn

Study Design

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

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 13, 2025
• Study Start: January 1, 2000
• Primary Completion (Estimated): December 31, 2070
• Study Completion (Estimated): December 31, 2070
• Last Updated: June 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)