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NCT02899169: APL16

Treatment of Non-high-risk Acute Promyelocytic Leukemia (APL) With Realgar-Indigo Naturalis Formula (RIF)

Status unknown Phase 3 Last updated 8 September 2021
What this trial tests

Phase 3 trial testing Realgar-Indigo naturalis formula in Acute Promyelocytic Leukemia in 110 participants. Status unknown.

Timeline
1 September 2016
Primary endpoint
1 September 2022
1 November 2022

Quick facts

Lead sponsorFirst Affiliated Hospital Xi'an Jiaotong University
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment110
Start date1 September 2016
Primary completion1 September 2022
Estimated completion1 November 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

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):

  1. 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
  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
  3. 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
  4. 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:

Other trials of Realgar-Indigo naturalis formula

Trials testing the same drug.

Other recruiting trials for Acute Promyelocytic Leukemia

Currently open trials in the same condition.

Other First Affiliated Hospital Xi'an Jiaotong University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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