A phase II trial in patients with acute promyelocytic leukaemia (APML) to evaluate the effects of: all-trans retinoic acid combined with intensive idarubicin during induction and consolidation; subsequent intermittent all-trans retinoic acid; and molecular monitorting for evidence of minimal residual leukaemia and for evidence of incipient relapse.
- Conditions
- Acute promyelocytic leukaemiaCancer - Leukaemia - Acute leukaemia
- Registration Number
- ACTRN12607000410459
- Lead Sponsor
- Australasian Leukaemia and Lymphoma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 107
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 least 50% as demonstrated by gated heart pool scan (preferably) or by cardiac ultrasound.
5. No previous treatment for APL, or history of cancer (other than basal cell skin cancer, or carcinoma of cervix in situ).
6. No contra-indication to use of any of the study drugs.
7. Treatment will be carried out at an affiliated ALLG centre, with approval of the protocol by the Institutional Human Ethics Committee or equivalent.
8. A negative pregnancy test in females of child-bearing age.
9. Written informed consent will be given by each patient.
There are no specified exclusion criteria. All patients who met the inclusion criteria were eligible for the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method