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Trial · NCT05832320

Optimum Induction Therapy of Low-risk APL

NCT05832320, Not applicable, Unknown, Peking University People's Hospital

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Optimum Induction Therapy of Low-risk APL. Trials, record NCT05832320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05832320

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Optimum Induction Therapy of Low-risk APL
NCT number
NCT05832320
Status
Unknown
Phases
Not applicable
Enrollment
74 participants, estimated
Lead sponsor
Peking University People's Hospital
Conditions
Acute Promyelocytic Leukemia, Induction Therapy, Oral
Interventions
Etoposide, Daunorubicin
First posted
2023-04-27
Last updated
2024-05-10

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryComplete remissionAt the end of induction therapy within 45 days after diagnosis
Haematological CR was defined as a proportion of BM blasts of \<5%, the absence of blasts in Auer rods, the absence of extramedullary disease, an absolute neutrophil count of \>1×10⁹/L and a platelet count of \>100×109/L, with no red-cell transfusions
PrimaryPromyelocytic leukaemia-retinoic acid receptor alpha (PML-RARA) transcript levels of ≥6.5% at the end of induction therapyAt the end of induction therapy within 45 days after diagnosisPML-RARA transcripts using Abelson tyrosine-protein kinase (ABL) as an internal control by quantitative RT-PCR
SecondaryEarly death (ED)During the induction therapy within 30 days after diagnosisDefined as death within 30 days after diagnosis
SecondaryCumulative recurrence rateFrom date of randomization until the date of last documented progression or date of death from any cause, whichever came first, assessed up to 2 yearsA measure of the total relapse that a certain event will happen during a given period of time
Secondary2-year event-free survival rateFrom the time of randomization to the time of last follow-up within 2 years after diagnosis
The EFS was defined as the time from diagnosis to the following events: no haematological CR after induction therapy; no CMR after consolidation therapy, molecular relapse, haematological relapse; death from any cause; or last follow-up.
SecondarySatefy. Common haematological and non-haematological adverse events were monitored twice per week during induction and twice per month during consolidation.From the time of randomization to the time of last follow-up within 2years after diagnosisToxic effects were graded according to the 'WHO classification standard for acute and subacute toxicity of anticancer drugs'.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT05832320

GET https://conductscience.org/api/trials/v1/NCT05832320/registered