Evidence map›Paper›PMID 30185214›Full record

Trial reportTrials2018

Arsenic trioxide and all-trans retinoic acid (ATRA) treatment for acute promyelocytic leukemia in all risk groups: study protocol for a randomized controlled trial.

Xinxin Zhang, Huiyun Zhang, Limei Chen, Mengchang Wang, Jieying Xi, Xin Liu, Ming Xie, Dengzhe Li, Ekamjyot Singh Gulati, Sha Gong and 1 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Xinxin ZhangDepartment of Hematology, First affiliated hospital of Xi'an Jiaotong University, Yanta West Road, Xi'an, 710061, Shaanxi, China.
Huiyun ZhangDepartment of Hematology, First affiliated hospital of Xi'an Jiaotong University, Yanta West Road, Xi'an, 710061, Shaanxi, China.
Limei ChenDepartment of Hematology, First affiliated hospital of Xi'an Jiaotong University, Yanta West Road, Xi'an, 710061, Shaanxi, China.
Mengchang WangDepartment of Hematology, First affiliated hospital of Xi'an Jiaotong University, Yanta West Road, Xi'an, 710061, Shaanxi, China.
Jieying XiDepartment of Hematology, First affiliated hospital of Xi'an Jiaotong University, Yanta West Road, Xi'an, 710061, Shaanxi, China.
Xin LiuDepartment of Hematology, First affiliated hospital of Xi'an Jiaotong University, Yanta West Road, Xi'an, 710061, Shaanxi, China.
Ming XieDepartment of Hematology, First affiliated hospital of Xi'an Jiaotong University, Yanta West Road, Xi'an, 710061, Shaanxi, China.
Dengzhe LiDepartment of Hematology, First affiliated hospital of Xi'an Jiaotong University, Yanta West Road, Xi'an, 710061, Shaanxi, China.
Ekamjyot Singh GulatiDepartment of Hematology, First affiliated hospital of Xi'an Jiaotong University, Yanta West Road, Xi'an, 710061, Shaanxi, China.
Sha GongDepartment of Hematology, First affiliated hospital of Xi'an Jiaotong University, Yanta West Road, Xi'an, 710061, Shaanxi, China.
Huaiyu WangDepartment of Hematology, First affiliated hospital of Xi'an Jiaotong University, Yanta West Road, Xi'an, 710061, Shaanxi, China. hywang@mail.xitu.edu.cn.ORCID http://orcid.org/0000-0002-6428-081X
First Affiliated Hospital of Xi'an Jiaotong University · CN

Funding

Clinical Research of the First Affiliated Hospital of Xi'an Jiaotong University,China XJTU1AHCR201-012
6 · The paper itself

Abstract

backgroundThe treatment of acute promyelocytic leukemia (APL) has been revolutionized in the past two decades by the advent of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO). It suggests that non-high-risk APL patients can be cured without chemotherapy. However, ATRA plus chemotherapy is still the standard therapy for the high-risk patients. Central nervous system (CNS) relapse remains a significant cause of treatment failure in high-risk patients. However, increasing the ATO concentration in cerebrospinal fluid (CSF) may reduce CNS relapse in high-risk patients. Mannitol can allow ATO to penetrate the blood-brain barrier (BBB) and reach therapeutically effective levels in the CSF. It is used for the treatment of CNS relapse in patients APL. We compare ATRA-ATO with ATRA-ATO plus chemotherapy in both high-risk and non-high-risk patients with APL.

methodsThis study was designed as a multicenter randomized controlled trial. Patients with APL were randomly assigned into two groups: the ATRA-ATO group (experimental group) and the ATRA-ATO plus chemotherapy group (control group). The experimental group receives therapy with ATRA-ATO for induction, consolidation and maintenance therapy. In the high-risk patients, mannitol will be used with ATO in the consolidation and maintenance therapy. Hydroxyurea will be used in patients who developed leukocytosis in the induction therapy. The control group receives therapy with ATRA-ATO plus chemotherapy for induction and consolidation therapy. DISCUSSION: In this study, a randomized clinical trial design is described. It aims to compare the efficacy of ATRA-ATO versus ATRA-ATO plus chemotherapy in all-risk patients with APL.

trial registrationChinese Clinical Trials Registry, ID: ChiCTR-IPR- 15006821 . Registered on 27 July 2015.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsArsenic TrioxideLeukemia, Promyelocytic, AcuteTretinoinAdolescentAdultAgedAged, 80 and overChinaFemaleHumansMaleMiddle AgedResearch DesignRisk AssessmentRisk FactorsArsenic TrioxideTretinoinAcute promyelocytic leukemiaAll-trans retinoic acidArsenic trioxideHydroxyureaMannitol

Identifiers

PMID30185214
PMCPMC6126003
OpenAlexW2890635518

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.