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.

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000410459

Enrollment

107

Registered

2007-08-13

Start date

1997-08-19

Completion date

2002-10-22

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 therapy.

Interventions

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

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to -2147483648 No limit

Healthy volunteers

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 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.

Exclusion criteria

There are no specified exclusion criteria. All patients who met the inclusion criteria were eligible for the trial.

Outcome results