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NCT04121819
AraC for Newly Diagnosed Adult Langerhans Cell Histiocytosis
Phase 2 trial testing Cytarabine in Langerhans Cell Histiocytosis in 40 participants. Status unknown.
31 December 2021
Quick facts
| Lead sponsor | Peking Union Medical College Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 October 2019 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Cytarabine — full drug profile →
Conditions studied
- Langerhans Cell Histiocytosis — all drugs for Langerhans Cell Histiocytosis →
Sponsor
Peking Union Medical College Hospital
Who can join
Adults 18 to 75, any sex, with Langerhans Cell Histiocytosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Langerhans cell histiocytosis (LCH) is a rare, heterogeneous histiocytic disorder occurring in patients of all ages from neonates to the elderly. The current standard treatment protocol for children with de novo multisystem LCH is vinblastine plus prednisone. This regimen has never been proven effective for adults in a prospective study, since the only prospective trial evaluating the efficacy of a vinblastine/prednisone regimen in adults was prematurely closed due to unacceptable toxicities. A retrospective study showed an advantage for cytarabine monotherapy compared with vinblastine/prednisone in bone LCH patients. This phase 2, prospective, single-center study is designed to evaluate the efficacy and safety of cytarabine monotherapy in adults with newly diagnosed MS-LCH or LCH with multifocal single system (SS-m) involvement.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Update on Pulmonary Langerhans Cell Histiocytosis.
Radzikowska E. · · 2020 · cited 21× · PMID 33763431 · DOI 10.3389/fmed.2020.582581 -
Phase 2 study using low dose cytarabine for adult patients with newly diagnosed Langerhans cell histiocytosis.
Chang L, Lang M, Lin H, Cai H, et al · · 2024 · cited 8× · PMID 38388646 · DOI 10.1038/s41375-024-02174-1 -
Adult Langerhans cell histiocytosis presenting with multisystem involvement and sarcomatoid features: a case report.
Aguirre LE, Schwartz I, Chapman J, Larsen MF, et al · · 2020 · cited 2× · PMID 32979930 · DOI 10.1186/s13256-020-02460-3
Verify or expand the search:
- PubMed search for NCT04121819
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Langerhans Cell Histiocytosis
Currently open trials in the same condition.
- NCT07187193 — Efficacy and Safety of Low-Dose Cytarabine Combined With Thalidomide in Adult Patients With Untreated LCH · Phase 2 · recruiting
- NCT05997602 — To Evaluate the Efficacy, Safety, and PK Characteristics of FCN-159 in Pediatric Patients With Refractory/Recurrent LCH · Phase 2 · recruiting
- NCT04773366 — A Prospective Study for the Treatment of Children With Newly Diagnosed LCH Using a Cytarabine Contained Protocol · Phase 3 · recruiting
- NCT03155620 — Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid T · Phase 2 · active not recruiting
Other Peking Union Medical College Hospital trials
Trials by the same sponsor.
- NCT07466251 — PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke · Phase 4 · not yet recruiting
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- NCT07590336 — 68Ga-NYM207 PET/CT Imaging in Hepatocellular Carcinoma · Phase 1, PHASE2 · not yet recruiting
- NCT07515976 — Mapping of Genomic Structural Variations in Major Birth Defects · not yet recruiting
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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 NCT04121819 (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 Peking Union Medical College Hospital
- Last refreshed: 8 June 2021
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/NCT04121819.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing