A phase II trial in patients with acute promyelocytic leukaemia (APML) to evaluate the effects of: all-trans retinoic acid (ATRA) combined with intensive idarubicin during induction and consolidation; subsequent intermittent all-trans retinoic acid; and molecular monitoring for evidence of minimal residual leukaemia and for evidence of incipient relapse, as measured by remission rate, relapse rate and overall survival. (APML03)
Australasian Leukaemia and Lymphoma Group (ALLG)Dataset description
Dataset includes: Data for 107 patients with newly diagnosed APL Treatment involved use of all-trans retinoic acid (ATRA) combined with idarubicin Demographic data Diagnostic data Treatment data Outcome dataSubjects
Chemotherapy |Identifiers
Source Study
Trial acronym
Not available
Trial ID
ACTRN12607000410459
Purpose
Treatment
Phase
Phase 2
Funding
Commercial sector/Industry,Pharmacia
Scientific enquiries
A/Prof A/Prof Harry Iland
Brief Summary
An Italian clinical trials group demonstrated excellent outcomes for the majority of APL patients when intensive idarubicin was added to ATRA for remission induction therapy. Their patients were then treated with conventional consolidation chemotherapy. In the APML3 trial, intensive idarubicin and ATRA are used for both induction and consolidation in order to exploit the unique sensitivity of APL to this combination. In addition, frequent molecular monitoring is used to determine post-remission .... Read more
Key Inclusion Criteria
1. Morphological diagnosis of de novo acute promyelocytic leukaemia 2. Demonstration of PML-RAR fusion transcripts by reverse transcriptase-polymerase chain reaction (RT-PCR) 3. Eastern Cooperative Oncology Group performance status 0-3, and absence of previous history of serious cardiac, pulmonary, hepatic or renal disease. A serum creatinine >200 micro mol/L or serum bilirubin >80µmol/L precludes entry into the study, unless medically correctable. 4. A left ventricular ejection fraction of at l .... Read more
Key Exclusion Criteria
There are no specified exclusion criteria. All patients who met the inclusion criteria were eligible for the trial.
Can healthy volunteers participate?
No
Population
Sample Size 107
Min. age 18 Years
Max. age -2147483648 No limit
Sex Both males and females
Condition category Acute promyelocytic leukaemia
Condition code Cancer
Intervention
Intervention code Treatment: Drugs
Induction therapy: Two cycles of intensive idarubicin 12mg /m2 intravenously (IV) on days 2, 4, 6 and 8, (9mg/m2 for age 61-70, and 6mg/m2 for age > 70), together with continuous ATRA 45mg/m2/day orally starting on day 1 and Prednisone 50mg/day orally. Consolidation: 3 cycles of ATRA (45mg/m2/day orally) for 2 weeks out of every 4-week cycle. Maintenance (for a total of 2 years): ATRA 45mg/m2/d orally for 15 days every 3 months plus 6-mercaptopurine (6MP) 90mg/m^2/d orally plus Methotrexate 15mg .... Read more
Comparison
Control group Uncontrolled
Uncontrolled
Outcomes
Outcome: 1. To maximise the complete remission rate (number of patients achieving remission) by combining all-trans retinoic acid (ATRA) with intensive idarubicin chemotherapy, assessed after induction cycle 1 and after induction cycle 2.Timepoint: Assessed after induction cycle 1 and after induction cycle 2.
Outcome: 2. To minimise the relapse rate by employing a second course of idarubicin followed by intermittent ATRA for eradication of minimal residual leukaemia as measured by the actuarial relapse free survival (measured from date of remission to date of relapse). This is measured annually, starting from one year after closure of trial to study close-out dateTimepoint: This is measured annually, starting from one year after closure of trial to study close-out date
Outcome: 3. To maximise overall survival (measured from day 1 to death) through an intensive program of molecular monitoring for the detection of incipient relapse, combined with an aggressive therapeutic intervention strategy aimed at eradication of low levels of recurrent leukaemia. Overall survival is measured annually, starting from one year after closure of trial to study close-out dateTimepoint: Overall survival is measured annually, starting from one year after closu .... Read more
Will individual participant data (IPD) for this trial be available?
yes
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 sponsor ALLG 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. Proposals will be assessed on a case-by-case basis