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A slow-growing type of leukemia (blood cancer) in which too many lymphocytes are found in the bone marrow and/or blood. The T-cell is specified as the defective cell line.
No approved treatments are currently available for T-cell prolymphocytic leukemia. An additional 1 compound holds orphan drug designation.
While no drugs are FDA-approved specifically for T-cell prolymphocytic 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 prolymphocytic leukemia. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name | Generic Name | Sponsor |
|---|
Estimated prevalence: Unknown (Unknown prevalence).
8 clinical trials registered, 5 recruiting. Interventions under study include drug therapy, other interventions, procedural interventions, and biologic therapy. Pipeline includes 1 PHASE2, 6 PHASE1. Research is sponsored by a mix of industry and academic institutions.
NCT ID | Title | Phase | Sponsor | Status |
|---|---|---|---|---|
[NCT07356245](https://clinicaltrials.gov/study/NCT07356245) |
Data assembled from 5 of 12 sources · Last updated Sep 18, 2026, 8:50 PM UTC
European rare disease database
Genetic and Rare Diseases Info Center
Common questions about T-cell prolymphocytic leukemia
Designated
Exclusivity End |
|---|
Designation Status |
|---|
tinostamustine hydrochloride | tinostamustine hydrochloride | Purdue Pharma L.P. | 2019 | — | Designated |
8 trials found
Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma |
PHASE2 |
Jonathan Brammer |
RECRUITING |
[NCT05010005](https://clinicaltrials.gov/study/NCT05010005) | A Study of Ruxolitinib and Duvelisib in People With Lymphoma | PHASE1 | Memorial Sloan Kettering Cancer Center | RECRUITING |
[NCT07311746](https://clinicaltrials.gov/study/NCT07311746) | Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukemia | PHASE1 | M.D. Anderson Cancer Center | RECRUITING |
[NCT05377827](https://clinicaltrials.gov/study/NCT05377827) | Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies | PHASE1 | Washington University School of Medicine | UNKNOWN |
[NCT06420076](https://clinicaltrials.gov/study/NCT06420076) | Sequential CAR-T Cells Therapy for CD5/CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5/CD7-Specific CAR-T Cells | PHASE1 | Essen Biotech | RECRUITING |
10 publications have been identified in PubMed for T-cell prolymphocytic leukemia. Research spans Basic Science / Preclinical (60%), Review / Meta-Analysis (20%), and Case Report / Case Series (10%).
Research Type | Count | % of Total |
|---|---|---|
Laboratory research | 6 | 60% |
Research summaries | 2 | 20% |
Patient case studies | 1 | 10% |
Disease patterns and progression | 1 | 10% |
Lopez-Sanchez C (2026). [PMID: 41236817](https://pubmed.ncbi.nlm.nih.gov/41236817/). *Leukemia & lymphoma*. [Basic Science / Preclinical]
Martínez-Caro J (2026). [PMID: 41588775](https://pubmed.ncbi.nlm.nih.gov/41588775/). *Journal of veterinary diagnostic investigation : official publication of the American Association of Veterinary Laboratory Diagnosticians, Inc*. [Review / Meta-Analysis]
GONZáLEZ-RODRíGUEZ LM (2025). [PMID: 40109866](https://pubmed.ncbi.nlm.nih.gov/40109866/). *Oncology research*. [Case Report / Case Series]
Kosmaczewska A (2025). [PMID: 41301417](https://pubmed.ncbi.nlm.nih.gov/41301417/). *Biomolecules*. [Basic Science / Preclinical]
Gamal W (2025). [PMID: 39938006](https://pubmed.ncbi.nlm.nih.gov/39938006/). *Blood advances*. [Basic Science / Preclinical]
Wolgast N (2025). [PMID: 41285750](https://pubmed.ncbi.nlm.nih.gov/41285750/). *Blood cancer journal*. [Epidemiology / Natural History]
Hoferkova E (2024). [PMID: 38877102](https://pubmed.ncbi.nlm.nih.gov/38877102/). *Leukemia*. [Basic Science / Preclinical]
van Bruggen JAC (2024). [PMID: 39042920](https://pubmed.ncbi.nlm.nih.gov/39042920/). *Blood advances*. [Basic Science / Preclinical]
AlZahrani A (2024). [PMID: 38149670](https://pubmed.ncbi.nlm.nih.gov/38149670/). *Hematology (Amsterdam, Netherlands)*. [Review / Meta-Analysis]
Smith AL (2024). [PMID: 38775157](https://pubmed.ncbi.nlm.nih.gov/38775157/). *JCI insight*. [Basic Science / Preclinical]