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RecruitingNCT07019766NICHE-LGLLUpdated Nov 12, 2026

National Longitudinal Cohort of Hematological Diseases-Large Granular Lymphocytic Leukemia

An observational study in T-LGL Leukemia and NK-LGL Leukemia, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Observational

From the registry’s dates

  • Started Jan 2000; still recruiting 26 years 10 months later.
Updated Nov 12, 20261 site added1 site removedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
9,999
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Leukemia, Large Granular Lymphocytic with a site in China — 9 open to participants now, 9 under way, 1 of them phase 3. Leukemia, Large Granular Lymphocytic · China.

Started
2000
the only one that year
Observational
3 of 10
3 open now
Registered
8th of 10
by date
Lead sponsor
7 of 10
Institute of Hematology & Blood Diseases Hospital, China

Among the 10 studies in Leukemia, Large Granular Lymphocytic with a site in China, this one is the only one that started in 2000, is one of 3 observational ones, and was the 8th registered.

Leukemia, Large Granular Lymphocytic

144 studies on the registry are indexed under Leukemia, Large Granular Lymphocytic; 19 are open to participants now.

Browse Leukemia, Large Granular Lymphocytic studies →

Open to participants now

9 of the 10 studies in Leukemia, Large Granular Lymphocytic with a site in China are open now. Recruiting first, the newest first:

3 more — sign in →

All 9 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 17 Leukemia, Large Granular Lymphocytic studies recruiting now, 13 (76%) set no upper age limit and 3 (18%) stop at 75 or younger; 4 take children under 18; none take healthy volunteers.

This study: all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Leukemia, Large Granular Lymphocytic with a site in China, or all of them as a file.
02

Study 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.
03

Conditions studied

  • T-LGL Leukemia
  • NK-LGL Leukemia

Keywords

  • Treatment patterns
  • Hematologic response
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
9,999 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherA combined retrospective and prospective observational follow-up

    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.

06

What researchers measure

Primary outcomes

  1. Hematologic response

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

    Time frame: 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.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2000 (actual). Primary completion is estimated for Dec 2070, 851 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 28, 2025
First posted
Jun 13, 2025
StartActual
Jan 1, 2000
Primary completionEst.
Dec 31, 2070
CompletionEst.
Dec 31, 2070
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added, 1 site removed
Show site
  • Red Blood Cell Diseases Center and Regenerative Medicine Center · Tianjin, China
Show 1 removed
  • Red Blood Cell Diseases Center and Regenerative Medicine Center · Tianjin, China
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    1 site added, 1 site removed
    Show site
    • Red Blood Cell Diseases Center and Regenerative Medicine Center · Tianjin, China
    Show 1 removed
    • Red Blood Cell Diseases Center and Regenerative Medicine Center · Tianjin, China
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07019766
Responsible party
Sponsor
First posted
Jun 13, 2025
Start date
Jan 1, 2000
Primary completion
Dec 31, 2070 (estimated)
Completion
Dec 31, 2070 (estimated)
Last update
Nov 12, 2026

Study contacts

Lele Zhang, PhD
Contact
zhanglele@ihcams.ac.cn
‭15811139278‬

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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