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NCT02846935
p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Refractory/Relapsed Lymphoid Malignancies
EARLY_PHASE1 trial testing Decitabine in T-cell Lymphoma in 7 participants. Completed in 22 January 2018.
22 January 2018
Quick facts
| Lead sponsor | Yogen Saunthararajah |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 7 |
| Start date | 25 April 2017 |
| Primary completion | 22 January 2018 |
| Estimated completion | 22 January 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Decitabine (decitabine) — full drug profile →
- Tetrahydrouridine — full drug profile →
Conditions studied
- T-cell Lymphoma — all drugs for T-cell Lymphoma →
- Aggressive B-cell Lymphoma — all drugs for Aggressive B-cell Lymphoma →
- Non-Hodgkin's Lymphomas — all drugs for Non-Hodgkin's Lymphomas →
- Indolent B-cell Lymphoma — all drugs for Indolent B-cell Lymphoma →
Sponsor
Yogen Saunthararajah — full company profile →
Who can join
18 and older, any sex, with T-cell Lymphoma or Aggressive B-cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate how well the study drug works and safety of oral decitabine in patients with refractory or relapsed lymphoid malignancies. The decitabine is being given at a lower dose than used for its approved use. It is also being given with another drug, tetrahydrouridine (THU), to improve the exposure of lymphoma cells to decitabine.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Metabolism, Biochemical Actions, and Chemical Synthesis of Anticancer Nucleosides, Nucleotides, and Base Analogs.
Shelton J, Lu X, Hollenbaugh JA, Cho JH, et al · · 2016 · cited 219× · PMID 27960273 · DOI 10.1021/acs.chemrev.6b00209 -
A pilot clinical trial of oral tetrahydrouridine/decitabine for noncytotoxic epigenetic therapy of chemoresistant lymphoid malignancies.
Hill B, Jagadeesh D, Pohlman B, Dean R, et al · · 2021 · cited 10× · PMID 33509441 · DOI 10.1053/j.seminhematol.2020.11.008 -
Epigenetic Symphony in Diffuse Large B-Cell Lymphoma: Orchestrating the Tumor Microenvironment.
Caloian AD, Cristian M, Calin E, Pricop AR, et al · · 2025 · cited 7× · PMID 40299416 · DOI 10.3390/biomedicines13040853 -
Epigenetic targets in B- and T-cell lymphomas: latest developments.
Ribeiro ML, Sánchez Vinces S, Mondragon L, Roué G. · · 2023 · cited 3× · PMID 37273421 · DOI 10.1177/20406207231173485
Verify or expand the search:
- PubMed search for NCT02846935
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07177079 — High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML · Phase 1 · recruiting
- NCT07148947 — Pacritinib With Standard of Care Azacitidine or Decitabine as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant · Phase 2 · recruiting
Other recruiting trials for T-cell Lymphoma
Currently open trials in the same condition.
- NCT07388563 — Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma · Phase 1 · recruiting
- NCT07356245 — Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma · Phase 2 · recruiting
- NCT06550427 — Early Assessment of Lymphoma Treatment Response Using Phased Variant Analysis With Next-Generation Sequencing · recruiting
- NCT04234048 — Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma · Phase 1 · recruiting
- NCT06224049 — Treatment of Relapsed or Refractory Epstein-Barr Virus Positive T-cell Lymphoma With hNeo-T · EARLY_PHASE1 · recruiting
Other Yogen Saunthararajah trials
Trials by the same sponsor.
- NCT02847000 — p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Pancreatic Cancer · EARLY_PHASE1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02846935 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Yogen Saunthararajah
- Last refreshed: 7 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02846935.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing