Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
This trial has a randomised design, consisting of two parts. In part 1, patients will receive 7 cycles of All-Trans Retinoic Acid (ATRA, tretinoin) (45mg/m^2, in 2 divided doses) + 4 cycles of IV ATO (0.15mg/kg/day) with the exception of week one of ATO cycle #2, and week one of ATO cycle # 4, when oral tablet ATO (0.15mg/kg/day) will be used. In part 2 of the trial, patients will receive Patients will be given 7 cycles of ATRA (45mg/m^2, in 2 divided doses) + 4 cycles of IV ATO, with the exception of week one of either ATO cycle #1 or ATO cycle #2, and week one of either ATO cycle #3 or ATO cycle #4, when oral tablet ATO will be used (sequence will be determined by randomisation).
Conditions
This trial is treating people with Acute Promyelocytic Leukaemia (APML)
Eligibility
Inclusion
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 per APML4).
6. An ECOG performance status score of 3 or less.
7. Absence of previous history of serious cardiac, pulmonary, hepatic or renal disease.
8. Serum creatinine less than or equal to 200µmol/L (unless medically correctable).
9. Serum bilirubin less than or equal to 50µmol/L (unless medically correctable).
10. ECG showing sinus rhythm and QTc interval (Framingham) < 450msec. Prolongation of QTc due to medication or electrolyte disturbance must be corrected before registration.
11. No contra-indication to use of any of the study drugs.
12. Has provided written informed consent.
13. Females of childbearing potential must have a negative pregnancy test at registration for APML5.
14. Females of childbearing potential and males must use an effective method of contraception or practice absolute abstinence during treatment and for 2 months after treatment discontinuation.
15. Participants must agree not to donate blood, semen or sperm whilst on study treatment and for 2 months after treatment discontinuation.
Exclusion
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.
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Australasian Leukaemia and Lymphoma Group (ALLG)
Scientific Title
A phase I pharmacokinetic evaluation of oral arsenic trioxide in previously untreated patients with acute promyelocytic leukaemia
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