Australasian Leukaemia and Lymphoma Group Acute Myeloid Leukaemia Trial 12 (ALLG M12)

A randomised trial of idarubicin dose escalation in consolidation therapy following intensive induction chemotherapy incorporating high dose cytarabine in patients with untreated adult acute myeloid leukaemia, to evaluate safety and improve remission rate.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000095662

Acronym

ALLG AMLM12

Enrollment

442

Registered

2005-08-05

Start date

2003-07-16

Completion date

2010-04-21

Last updated

2023-07-25

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

Conditions

None listed

Brief summary

Improvements in treatment results for adult acute myeloid leukaemia (AML) over the past 15 years have come mainly from the use of higher dose intensity of existing chemotherapy agents, rather than from the introduction of new classes of anti-leukaemic drugs. Increased dose intensity protocols have included the use of chemo-radiotherapy, Early intensification of treatment using the most effective drugs available for AML is a highly effective strategy, possibly through rapid elimination of potentially drug-resistant cells. Hypothesis; a) That Palifermin, given as three doses of 60 µg/kg per day IV before and three doses after ICE chemotherapy, will reduce the incidence of grades 3 and 4 oral mucositis. b) That an increase in the dose intensity of Idarubicin given early during the initial treatment of AML will result in significantly greater anti-leukaemic activity, and that this dose escalation of Idarubicin in consolidation treatment following induction therapy with high dose Cytarabine will achieve improved leukaemia-free survival.

Interventions

Comparison of two dose levels of Idarubicin in the consolidation phase of chemotherapy for AML. All patients receive the same induction therapy with Idarubicin, high dose cytarabine, and etoposide. Complete responders are then randomised, and receive 2 courses of consolidation therapy with conventional dose cytarabine, etoposide, and Idarubicin at either standard dosage (9mg per square metre daily for 2 days) or in the experimental arm 9mg per square metre daily for 3 days.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

15 Years to 60 Years

Healthy volunteers

Inclusion criteria

1. A morphological diagnosis of AML by WHO criteria, confirmed by special stains, immunophenotyping and cytogenetics. All clinico-pathological subtypes will be eligible, except for AML with t(15;17) or variants, or core-binding factor AML (t(8;21) or inv16 or variants). 2. ECOG performance status 0 to 3 inclusive. 3. Absence of serious cardiac, pulmonary, hepatic or renal disease. A serum creatinine <200 mmol/L and serum bilirubin < 2.5 times the upper limit of normal, unless medically correctable. 4. Normal left ventricular ejection fraction, according to institutional criteria. If the clinical circumstances require that treatment must be given urgently before this can be ascertained, the absence of clinical cardiac impairment is acceptable, provided that a normal left ventricular ejection fraction is confirmed prior to the first consolidation cycle. 5. No previous treatment for AML or history of cancer (other than basal cell skin cancer or carcinoma of the cervix in situ, or other localized cancer treated by surgical excision only more than 5 years earlier without evidence of recurrence in the intervening period ). 6. No contraindication to the use of the study drugs. 7. Treatment must be given at an affiliated ALLG centre, with approval of the protocol by the institutions Human Ethics Committee, or equivalent body. 8. Written informed consent must be obtained from each patient prior to registration and start of treatment.

Exclusion criteria

No exclusion criteria

Outcome results