Not available
ACTRN12605000070639
Treatment
Phase 2
Charities/Societies/Foundations,Leukaemia Foundation of Australia
Prof A/Prof Harry Iland
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 .... Read more
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 .... Read more
No exclusion criteria
No
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 .... Read more
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: -
yes
De-identified IPD data, for all data collected during the trial
Data available 3 months following publication, for an indefinite period
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.
Any type of analysis Assessed on a case-by-case basis