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T-cell large granular lymphocyte leukemia (T-cell LGL leukemia) is a lymphoproliferative malignancy that arises from the mature T-cell (CD3+) lineage.
Biomarker and diagnostic research for T-cell large granular lymphocyte leukemia has been reported in the published literature.
No approved treatments are currently available for T-cell large granular lymphocyte leukemia. An additional 1 compound holds orphan drug designation.
While no drugs are FDA-approved specifically for T-cell large granular lymphocyte leukemia, some of the following designated compounds may be used off-label in clinical practice. Treatment decisions should be made in consultation with a specialist familiar with this condition.
The following drugs have received orphan drug designation from the FDA for T-cell large granular lymphocyte leukemia. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name | Generic Name | Sponsor | Designated | Exclusivity End | Designation Status |
|---|---|---|---|---|---|
human anti-CD94 IgG1 monoclonal antibody (non-fucosylated) | human anti-CD94 IgG1 monoclonal antibody (non-fucosylated) | Dren Bio, Inc | 2023 | — | Designated |
Gene therapy approaches for T-cell large granular lymphocyte leukemia have been reported in the published literature.
15 trials found
Estimated prevalence: Unknown (Unknown prevalence).
15 clinical trials registered, 11 recruiting. Interventions under study include drug therapy, other interventions, medical devices, and gene therapy. Pipeline includes 4 PHASE2, 4 PHASE1. Research is sponsored by a mix of industry and academic institutions.
NCT ID | Title | Phase | Sponsor | Status |
|---|---|---|---|---|
[NCT05978141](https://clinicaltrials.gov/study/NCT05978141) | A Registry for People With T-cell Lymphoma | — | Memorial Sloan Kettering Cancer Center | RECRUITING |
[NCT01137643](https://clinicaltrials.gov/study/NCT01137643) | Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer | — | UNC Lineberger Comprehensive Cancer Center | RECRUITING |
[NCT02863692](https://clinicaltrials.gov/study/NCT02863692) | Registry of the German CLL Study Group | — | German CLL Study Group | RECRUITING |
[NCT06530550](https://clinicaltrials.gov/study/NCT06530550) | PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas | PHASE2 | Institute of Hematology & Blood Diseases Hospital, China | RECRUITING |
[NCT06530576](https://clinicaltrials.gov/study/NCT06530576) | Thalidomide for the Symptomatic Large Granular Lymphocytic Leukemia | PHASE2 | Institute of Hematology & Blood Diseases Hospital, China | RECRUITING |
23 publications have been identified in PubMed for T-cell large granular lymphocyte leukemia. Research spans Case Report / Case Series (48%), Basic Science / Preclinical (17%), and Review / Meta-Analysis (9%).
Research Type | Count | % of Total |
|---|---|---|
Patient case studies | 11 | 48% |
Laboratory research | 4 | 17% |
Research summaries | 2 | 9% |
Disease patterns and progression | 2 | 9% |
New treatment approaches | 2 | 9% |
Other research | 1 |
Favrin G (2026). [PMID: 42229081](https://pubmed.ncbi.nlm.nih.gov/42229081/). *Leuk Res*. [Other]
Hu N (2026). [PMID: 41577641](https://pubmed.ncbi.nlm.nih.gov/41577641/). *Thoracic cancer*. [Case Report / Case Series]
Upadhyayula BS (2026). [PMID: 41482347](https://pubmed.ncbi.nlm.nih.gov/41482347/). *Cancer genomics & proteomics*. [Basic Science / Preclinical]
Chaggar G (2026). [PMID: 41913969](https://pubmed.ncbi.nlm.nih.gov/41913969/). *Can J Neurol Sci*. [Case Report / Case Series]
Calabretto G (2025). [PMID: 40721648](https://pubmed.ncbi.nlm.nih.gov/40721648/). *Leukemia*. [Basic Science / Preclinical]
Gernert M (2025). [PMID: 39853385](https://pubmed.ncbi.nlm.nih.gov/39853385/). *Zeitschrift fur Rheumatologie*. [Review / Meta-Analysis]
Semenzato G (2025). [PMID: 39363880](https://pubmed.ncbi.nlm.nih.gov/39363880/). *Haematologica*. [Epidemiology / Natural History]
Nigro A (2025). [PMID: 40377873](https://pubmed.ncbi.nlm.nih.gov/40377873/). *Inflammopharmacology*. [Gene Therapy / Novel Therapeutics]
Kotsiafti A (2025). [PMID: 40831436](https://pubmed.ncbi.nlm.nih.gov/40831436/). *International journal of laboratory hematology*. [Case Report / Case Series]
El Asmar S (2025). [PMID: 41025032](https://pubmed.ncbi.nlm.nih.gov/41025032/). *Oxford medical case reports*. [Case Report / Case Series]
Data assembled from 5 of 12 sources · Last updated Sep 19, 2026, 12:51 AM UTC
European rare disease database
Genetic and Rare Diseases Info Center
Common questions about T-cell large granular lymphocyte leukemia
Testing and diagnosis research | 1 | 4% |
AI-curated news mentioning T-cell large granular lymphocyte leukemia
Updated Sep 10, 2026
Recent research shows that bendamustine monotherapy achieves high response rates and inhibits STAT3 in patients with high burden T-cell large granular lymphocytic leukemia. This study highlights the potential of bendamustine as an effective treatment option for this rare leukemia.