APML4 A phase II trial in patients with previously untreated acute promyelocytic leukaemia to evaluate the effects of: (i) adding arsenic trioxide to all-trans retinoic acid and idarubicin for remission induction, and (ii) adding arsenic trioxide to all-trans retinoic acid as consolidation

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes: Data on 200 patients with acute non-lymphocytic leukaemia . High dose Ara-C daunorubicin and VP16-213 (HIDAC-37) versus conventional dose and complete remission in adults. Remission duration/survival. Toxicity of two treatment arms. Prognostic variables. Cytogenetics.
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Source Study

Trial acronym

Not available

Trial ID





Phase 2


Charities/Societies/Foundations,Leukaemia Foundation of Australia

Scientific enquiries

Prof A/Prof Harry Iland

Brief Summary

Acute promyelocytic leukemia (APL) is a unique subtype of acute myeloid leukemia that is characterized by distinct clinical and laboratory abnormalities. It is associated with a striking risk of early death due to bleeding. Fortunately, the outcome for patients with APL has improved dramatically following the introduction of all-trans retinoic acid (ATRA) and its combination with chemotherapeutic drugs such as idarubicin. Patients with a white cell count > 10 x 109/L at diagnosis are at particul ....
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Key Inclusion Criteria

1. Morphological diagnosis of APL, either classical FAB-M3 or variant FAB-M3v. The leukaemia must have occurred de novo, with no previous history of preleukaemia, myelodysplasia, or myeloproliferative disorder. 2. Demonstration of PML-RARA fusion transcripts by reverse transcriptase-polymerase chain reaction (RT-PCR). 3. ECOG performance status 0-3. 4. Absence of previous history of serious cardiac, pulmonary, hepatic or renal disease, and absence of history of grand mal seizures. A serum creati ....
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Key Exclusion Criteria

No exclusion criteria

Can healthy volunteers participate?




Sample Size    129

Min. age    1 Years

Max. age    0 Not stated

Sex    Both males and females

Condition category    Acute promyelocytic leukaemia (APL)

Condition code    Cancer


Intervention code Treatment: Drugs

A single arm phase II study of all-trans retinoic acid (ATRA), idarubicin and arsenic trioxide (As2O3) over 36 days as induction therapy for acute promyelocytic leukaemia, followed by two cycles of consolidation with ATRA and As2O3 (over 28 days and 35 days respectively). Prednisone is administered during induction for all patients. Consolidation is followed by 2 years of maintenance therapy with daily 6-mercaptopurine, once weekly methotrexate, and 2 weeks of ATRA every 3 months. Bone marrow sa ....
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Control group Uncontrolled



Outcome: 1. To evaluate in a group of patients with de novo APL the effect of a chemotherapy protocol consisting of arsenic trioxide added to standard induction (ATRA plus intensive idarubicin) and two cycles of consolidation (ATRA plus As2O3) on time to molecular relapse.
Timepoint: -

Outcome: 2. To assess the effect of obligatory use of prednisone (or prednisolone) and aggressive haemostatic support, during induction, on early death rate (defined as death within the first 30 days).
Timepoint: -

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