International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia

Summary

The main purpose of this study is :

1. To establish which number of doses of gemtuzumab ozogamicin (up to a maximum of 3 doses) is tolerated and can be safety delivered in combination with cytarabine plus mitoxantrone or liposomal daunorubicin in induction
2. To compare mitoxantrone (anthracenedione) \& cytarabine with liposomal daunorubicin (anthracycline) \& cytarabine as induction therapy. (Randomisation 1 (R1) closed early to recruitment on 8th September 2017, due to liposomal daunorubicin manufacturing issues resulting in unavailability of the drug.)
3. To compare a single dose of gemtuzumab ozogamicin with the optimum tolerated number of doses of gemtuzumab ozogamicin (identified by the dose-finding study) when combined with induction chemotherapy.
4. To compare two consolidation regimens: high dose cytarabine (HD Ara-C) and fludarabine \& cytarabine (FLA) in standard risk patients.
5. To compare the toxicity and effectiveness of two haemopoietic stem cell transplant (HSCT) conditioning regimens of different intensity: conventional myeloablative conditioning (MAC) with busulfan/cyclophosphamide and reduced intensity conditioning (RIC) with fludarabine/busulfan.

Conditions

• Acute Myeloid Leukaemia

Interventions

DRUG

Gemtuzumab ozogamicin

Antibody-conjugated chemotherapy agent.

DRUG

Liposomal daunorubicin

Anthracycline (Randomisation 1 (R1)) closed early to recruitment on 8th September 2017, due to liposomal daunorubicin manufacturing issues resulting in unavailability of the drug.

DRUG

Mitoxantrone

DNA-reactive agent

DRUG

Fludarabine

A water-soluble fluorinated nucleotide analogue of the antiviral agent vidarabine.

DRUG

Cytarabine

Pyrimidine nucleoside analogue, an antineoplastic agent.

DRUG

Busulfan

Alkylsulfonate

DRUG

Cyclophosphamide

A nitrogen mustard alkylating agent from the oxazaphosphorine group

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris

  collaborator OTHER

• Cancer Research UK

  collaborator OTHER

• National Cancer Institute, France

  collaborator OTHER_GOV

• Pfizer

  collaborator INDUSTRY

• University of Birmingham

  lead OTHER

Principal Investigators

• Brenda Gibson · Royal Hospital for Children Glasgow

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2031-12-31

Completion

2032-12-31

Countries

• Australia
• France
• Ireland
• New Zealand
• Switzerland
• United Kingdom

Study Locations