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NCT02899169: APL16
Treatment of Non-high-risk Acute Promyelocytic Leukemia (APL) With Realgar-Indigo Naturalis Formula (RIF)
Phase 3 trial testing Realgar-Indigo naturalis formula in Acute Promyelocytic Leukemia in 110 participants. Status unknown.
1 September 2022
Quick facts
| Lead sponsor | First Affiliated Hospital Xi'an Jiaotong University |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 110 |
| Start date | 1 September 2016 |
| Primary completion | 1 September 2022 |
| Estimated completion | 1 November 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Realgar-Indigo naturalis formula
- all-trans retinoic acid
- Arsenic trioxide (ARSENIC TRIOXIDE) — full drug profile →
- Hydroxyurea — full drug profile →
Conditions studied
- Acute Promyelocytic Leukemia — all drugs for Acute Promyelocytic Leukemia →
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Who can join
Adults 14 to 70, any sex, with Acute Promyelocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigators design a multicenter randomized controlled trial to prove that RIF plus ATRA is possibly superior to ATO plus ATRA as consolidation and maintenance treatment for the patients with non-high-risk APL.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Advances and challenges in retinoid delivery systems in regenerative and therapeutic medicine.
Ferreira R, Napoli J, Enver T, Bernardino L, et al · · 2020 · cited 81× · PMID 32848154 · DOI 10.1038/s41467-020-18042-2 -
All-trans retinoic acid in hematologic disorders: not just acute promyelocytic leukemia.
Chen Y, Tong X, Lu R, Zhang Z, et al · · 2024 · cited 16× · PMID 39027338 · DOI 10.3389/fphar.2024.1404092 -
Treatment of non-high-risk acute promyelocytic leukemia with realgar-indigo naturalis formula (RIF) and all-trans retinoid acid (ATRA): study protocol for a randomized controlled trial.
Zhang X, Liu L, Yao Y, Gong S, et al · · 2020 · cited 4× · PMID 31898521 · DOI 10.1186/s13063-019-3983-2 -
Arsenic trioxide <i>versus</i> Realgar-Indigo naturalis formula in non-high-risk acute promyelocytic leukemia: a multicenter, randomized trial.
Chen S, Qin W, Lu X, Liu L, et al · · 2025 · PMID 39506905 · DOI 10.3324/haematol.2024.285905
Verify or expand the search:
- PubMed search for NCT02899169
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Realgar-Indigo naturalis formula
Trials testing the same drug.
- NCT05297123 — Treatment of Acute Myeloid Leukemia With Arsenic and All-trans Retinoid Acid · Phase 1 · unknown
Other recruiting trials for Acute Promyelocytic Leukemia
Currently open trials in the same condition.
- NCT05832320 — Optimum Induction Therapy of Low-risk APL · NA · recruiting
- NCT04687176 — Frontline Oral Arsenic Trioxide for APL · Phase 2 · recruiting
- NCT04793919 — Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia · Phase 2 · recruiting
Other First Affiliated Hospital Xi'an Jiaotong University trials
Trials by the same sponsor.
- NCT07389460 — Intravenous rhPro-UK Before Stroke Thrombectomy in the Extended Time Window (BRIDGE-PUK EXTEND) · Phase 3 · not yet recruiting
- NCT07170176 — Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine · NA · recruiting
- NCT07168291 — Novel Bispecific AbTCR (Anti-CD19/CD22)-T Cells in Relapsed or Refractory B-cell Lymphoma · EARLY_PHASE1 · not yet recruiting
- NCT06775782 — Remote Ischemic Conditioning for Acute Moderate Ischemic Stroke Due to Large Artery Atherosclerosis · NA · recruiting
- NCT07266467 — Efficacy and Safety of Leymovir Versus Valganciclovir in Prevention of Cytomegalovirus Infection and Cytomegalovirus Dis · Phase 4 · recruiting
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 NCT02899169 (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 First Affiliated Hospital Xi'an Jiaotong University
- Last refreshed: 8 September 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/NCT02899169.
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