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Oral etoposide combined with realgar natural indigo tablets and all-trans retinoic acid in the treatment of high-risk acute promyelocytic leukemia

Registration number：

ITMCTR2100005369

Date of Last Refreshed on：

2021-12-02

Date of Registration：

2021-12-02

Registration Status：

Prospective registration

Public title：

Oral etoposide combined with realgar natural indigo tablets and all-trans retinoic acid in the treatment of high-risk acute promyelocytic leukemia

English Acronym：

Scientific title：

Oral etoposide combined with realgar natural indigo tablets and all-trans retinoic acid in the treatment of high-risk acute promyelocytic leukemia

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2100053926 ; ChiMCTR2100005369

Applicant：

Wenbing Duan

Study leader：

Hao Jiang

Applicant telephone：

18513599785

Study leader's telephone：

13601164350

Applicant Fax：

Study leader's fax：

Applicant E-mail：

287969762@qq.com

Study leader's E-mail：

2516735116@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

11 Xizhimen Street South, Xicheng District, Beijing, China

Study leader's address：

11 Xizhimen Street South, Xicheng District, Beijing, China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Peking University People's Hospital

Approved by ethic committee：

Approved No. of ethic committee：

2021PHB311-001

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Peking University People's Hospital

Date of approved by ethic committee：

2021/11/18 0:00:00

Contact Name of the ethic committee：

Contact Address of the ethic committee：

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

People's Hospital, Institute of Hematology, Peking University

Primary sponsor's address：

11 Xizhimen Street South, Xicheng District, Beijing, China

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Peking University People's Hospital

Address：

11 Xizhimen Street South, Xicheng District, Beijing, China

Source(s) of funding：

Research and development fund of Peking University People's Hospital（Scientific Research）

Target disease：

high-risk acute promyelocytic leukemia

Target disease code：

Study type：

Interventional study

Study design：

Single arm

Study phase：

Phase I clinical trial

Objectives of Study：

Efficacy and safety of oral etoposide combined with realgar natural indigo tablets and all-trans retinoic acid in the treatment of high-risk acute promyelocytic leukemia（APL）

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1）Newly diagnosed high-risk APL（WHO classification 2016);2) Age from 18-70(18 and 70 are included);3) Without uncontrolled active infection;4) Without organ failure;5) Liver function:serum ALT and AST≤2.5*ULN,serum bilirubin≤2.0*ULN;6) Kidney function:serum Cr≤3.0*ULN

Exclusion criteria：

1) With cerebral hemorrhage; 2) Gestation;3) Suffering from mental illness or other conditions that cannot be carried out according to the scheme;4) Unable to take oral drugs;5) Uncontrolled active infection;6) Organ failure; 7) Allergic to etoposide.

Study execute time：

From 2022-01-01

To      2023-12-31

Recruiting time：

From 2022-01-01

To      2023-12-31

Interventions：

26

Group：

Oral etoposide group

Sample size：

Intervention：

Oral etoposide

Intervention code：

Total sample size ： 26

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

Peking University People's Hospital

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Overall survival rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

safety

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Event free survival rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

cumulative recurrence rate（1year 、2year））

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

remission rate

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

death rate

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

Min age years
Max age years

Recruiting status：

Participant age：

Gender：

Male

Randomization Procedure (please state who generates the random number sequence and by what method)：

Single arm studies

Blinding：

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

2024-12-31

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

1 Case report form (CRF) CRF is in duplicate for the researcher to fill in correctly. Each chosen subject should complete CRF. After reviewing the completed CRFs for their accuracy, main researchers should hand them in to the data administrator for data input and administration. The researcher will keep another copy of CFR. 2 Clinical monitoring and check To be consistent with GCP guideline, the monitor will visit regularly to ensure the research plan, GCP and relevant laws are in conformity with the guideline. The visit includes checking CRFs on-site to see whether they are complete and clear, to check with the raw documents and so forth. 3 Data input and revision Data administrator is responsible for data input and revision. All data will be input into the database, and their logic will be checked. The data administrator will fill in the question answering form for any doubts. 4 Data review and lock in After all the problems are solved and the database is confirmed to be correct, the data administrator will write the data management review report. Main researchers, statisticians and data administrator will hold the data review meeting to confirm the data to be analyzed and lock the reviewed data. The locked data will not be revised. 5 Data storage Data input in CRF should be consistent with the raw documents or directly input into CFR. When CRF is input directly, the parameters of the raw materials should be verified and source information should be recorded. All the raw materials of documents should be reserved until the researcher is notified to destroy them.

Data Managemen Committee：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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