Trial · NCT01191541
Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)
NCT01191541, Phase 4, Completed, Xiaofan Zhu; results first posted 2021-02-21
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL). Trials, record NCT01191541. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01191541
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)
- NCT number
- NCT01191541
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 65 participants, actual
- Lead sponsor
- Xiaofan Zhu
- Conditions
- Leukemia
- Interventions
- DNR:, Ara-c
- First posted
- 2010-08-31
- Last updated
- 2021-08-10
- Results first posted
- 2021-02-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | the Overall Survival of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial | two years | We assessed the OS of APL patients when ATRA and ATO were used. The overall survival (OS) durations was calculated from the date of diagnosis to last follow-up or death. |
| Primary | the Event-free Survival (EFS） of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial | 2 years | We assessed the EFS of APL patients treated with retinoic acid receptor alpha (ATRA) and Arsenic Trioxide (ATO) based trial. Event-free survival (EFS) was defined as time from diagnosis to last follow-up or an event (relapse or death). |
| Secondary | Number of Participants With Side Effects | three years | Also, we compared the side effect and outcome between the two groups.To assessed whether Ara-C could be omitted when ATO and ATRA were used. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | the Overall Survival of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial | two years | There were 65 patients included in our study, including 35 in the DNR group and 30 in the DNR+Ara-C group. | participants | NUMBER |
| PRIMARY | the Event-free Survival (EFS） of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial | 2 years | There were 65 patients included in our study, including 35 in the DNR group and 30 in the DNR+Ara-C group. | participants | NUMBER |
| SECONDARY | Number of Participants With Side Effects | three years | There were 66 patients included in our study. One patient gave up treatment due to the economic reasons. Then the number of the patients were 65, including 35 in the DNR group and 30 in the DNR+Ara-C group. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| the Overall Survival of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial | DNR Group | relapse | 1 | participants | |
| the Overall Survival of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial | DNR+Ara-C Group | relapse | 0 | participants | |
| the Overall Survival of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial | DNR Group | died | 0 | participants | |
| the Overall Survival of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial | DNR+Ara-C Group | died | 0 | participants | |
| the Event-free Survival (EFS） of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial | DNR+Ara-c(Ara-C Group) | relapse | 0 | participants | |
| the Event-free Survival (EFS） of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial | DNR(No Ara-C Group) | relapse | 1 | participants | |
| the Event-free Survival (EFS） of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial | DNR+Ara-c(Ara-C Group) | die | 0 | participants | |
| the Event-free Survival (EFS） of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial | DNR(No Ara-C Group) | die | 0 | participants | |
| Number of Participants With Side Effects | DNR+Ara-c (Ara-C Group) | sepsis | 5 | Participants | |
| Number of Participants With Side Effects | DNR (No Ara-c Group) | sepsis | 1 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| All the Patients | STARTED | Daunorubicin(DNR)+Ara-c (Ara-C Group) | 30 | |
| All the Patients | STARTED | DNR (No Ara-c Group) | 35 | |
| All the Patients | COMPLETED | Daunorubicin(DNR)+Ara-c (Ara-C Group) | 30 | |
| All the Patients | COMPLETED | DNR (No Ara-c Group) | 35 | |
| All the Patients | NOT COMPLETED | Daunorubicin(DNR)+Ara-c (Ara-C Group) | 0 | |
| All the Patients | NOT COMPLETED | DNR (No Ara-c Group) | 0 | |
| the Randomized Patients | STARTED | Daunorubicin(DNR)+Ara-c (Ara-C Group) | 30 | |
| the Randomized Patients | STARTED | DNR (No Ara-c Group) | 35 | |
| the Randomized Patients | COMPLETED | Daunorubicin(DNR)+Ara-c (Ara-C Group) | 30 | |
| the Randomized Patients | COMPLETED | DNR (No Ara-c Group) | 35 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events112
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | extremity oedema | General disorders | All the Patients at Presentation | 0 | 65 | 0 |
| other | extremity oedema | General disorders | the Adverse Events Associated With ATRA | 0 | 65 | 0 |
| other | extremity oedema | General disorders | the Adverse Events Associated With ATO | 9 | 65 | 9 |
| other | extremity oedema | General disorders | Consolidation: IDA | 0 | 65 | 0 |
| other | extremity oedema | General disorders | Consolidation: ATO | 0 | 65 | 0 |
| other | extremity oedema | General disorders | Consolidation: DNR (No Ara-c Group) | 0 | 35 | 0 |
| other | extremity oedema | General disorders | Consolidation: DNR+Ara-c (Ara-C Group) | 0 | 30 | 0 |
| other | extremity oedema | General disorders | Maintenance: ATRA+MTX+6-MP | 0 | 65 | 0 |
| other | nausea | Gastrointestinal disorders | All the Patients at Presentation | 0 | 65 | 0 |
| other | nausea | Gastrointestinal disorders | the Adverse Events Associated With ATRA | 7 | 65 | 7 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All the Patients at Presentation | 0 | 65 |
| Total, all-cause mortality | the Adverse Events Associated With ATRA | 0 | 65 |
| Total, all-cause mortality | the Adverse Events Associated With ATO | 0 | 65 |
| Total, all-cause mortality | Consolidation: IDA | 0 | 65 |
| Total, all-cause mortality | Consolidation: ATO | 0 | 65 |
| Total, all-cause mortality | Consolidation: DNR (No Ara-c Group) | 0 | 35 |
| Total, all-cause mortality | Consolidation: DNR+Ara-c (Ara-C Group) | 0 | 30 |
| Total, all-cause mortality | Maintenance: ATRA+MTX+6-MP | 0 | 65 |
| Total, other adverse events | All the Patients at Presentation | 0 | 65 |
| Total, other adverse events | the Adverse Events Associated With ATRA | 55 | 65 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01191541
GET https://conductscience.org/api/trials/v1/NCT01191541/events?page=2