A phase I pharmacokinetic evaluation of oral arsenic trioxide in previously untreated patients with acute promyelocytic leukaemia (APML05)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes: Data for 31 Patients with newly diagnosed APL Randomised controlled trial, with patients receiving oral arsenic, vs intravenous arsenic Diagnostic data, treatment data, outcome data Cancer Australia demographic data -Year of birth -Aboriginal or Torres Strait Islander status (or Ethnicity)
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Chemotherapy |

Source Study




Phase 1


Other Collaborative groups,Australasian Leukaemia and Lymphoma Group

Scientific enquiries

Prof Harry Iland

Brief Summary

PURPOSE This study will determine the safety and pharmacokinetics of oral arsenic trioxide (ATO) in consolidation therapy for Acute Promyelocytic Leukaemia (APML) WHO IS IT FOR? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with APML, and are in complete remission following induction with ATRA + ATO, or ATRA + ATO + idarubicin (high risk APML patients). STUDY DETAILS Enrolled participants will have achieved haematological remission following standa ....
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Key Inclusion Criteria

1. Patient has consented to and registered with the National Blood Cancer Registry (NBCR). 2. Morphological diagnosis of APL, either classical FAB-M3 or variant FAB-M3v. 3. Diagnosis of APL has been confirmed by the presence of PML-RARA fusion transcripts in pre-treatment blood or bone marrow. 4. Age greater than or equal to 18 years 5. In haematological complete remission (hCR or hCRi) following induction with ATRA + ATO (standard-risk as per APL0406) or ATRA + ATO + idarubicin (high-risk as pe ....
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Key Exclusion Criteria

Failure to meet the inclusion criteria, or the presence of any of the following, will exclude the participant from enrolment in the study: 1. Participants aged < 18 years. 2. Women who are pregnant or lactating. 3. Has any other clinically important abnormalities or conditions as determined by the investigator that may interfere with his or her participation in the trial or compliance with the trial protocol.

Can healthy volunteers participate?




Sample Size    31

Min. age    18 Years

Max. age    No limit

Sex    Both males and females

Condition category    Acute Promyelocytic Leukaemia

Condition code    Cancer


Intervention code Treatment: Drugs

This is a phase 1 study that looks at the bioavailability of an oral arsenic trioxide (ATO) in consolidation therapy for APML. Following standard induction therapy of All-Trans Retinoic Acid (ATRA, tretinoin) + IV ATO (+ idarubucin for high-risk patient), patients will be registered into the trial after documentation of haemotological complete remission. The study consists of two parts: (i) A 1-sequence, 4 ATO period single arm study over 28 weeks in total. Patients will be given 7 cycles of All ....
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Control group Active

The IV ATO is the control formulation for the oral ATO with each patient in this cross over study.


Outcome: Composite outcomes: (a) To determine the absorption and PK characteristics of an oral capsule formulation of ATO (intrasubject comparison of peak serum level and AUC0-24); (b) To determine the recommended phase 2 dose (RP2D) or oral ATO for use in a subsequent phase 2 study to examine efficacy.
Timepoint: In part (ii), there are two co-primary endpoints. AUC: 0-24. The area under the curve of arsenic concentrations in the blood (micromol/l), from time zero (imme ....

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Study Protocol: Study protocol
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

De-identified IPD data for all data collected during the trial

When will data be available?

Data available 3 months following publication, for an indefinite period

Available to whom?

Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.

Available for what types of analyses?

Any type of analysis Assessed on a case-by-case basis

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see