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JOURNAL ONKOLOGIE – STUDIE
Myechild01

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

Rekrutierend

NCT-Nummer:
NCT02724163

Studienbeginn:
April 2016

Letztes Update:
08.10.2021

Wirkstoff:
Gemtuzumab Ozogamicin, Liposomal daunorubicin, Mitoxantrone, Fludarabine, Cytarabine, Busulfan, Cyclophosphamide

Indikation (Clinical Trials):
Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute

Geschlecht:
Alle

Altersgruppe:
Kinder (0-17)

Phase:
Phase 3

Sponsor:
University of Birmingham

Collaborator:
Assistance Publique - Hôpitaux de Paris, Cancer Research UK, National Cancer Institute, France, Pfizer,

Studienleiter

Brenda Gibson
Principal Investigator
Royal Hospital for Children Glasgow

Kontakt

Studienlocations
(3 von 68)

Centre Hospitalier Universitaire Amiens - Picardie
Amiens
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Centre Hospitalier Universitaire D'angers
Angers
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Centre Hospitalier Regional Universitaire Besancon - Hopital Jean Minjoz
Besançon
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Centre Hospitalier Universitaire De Bordeaux - Hopital Pellegrin
Bordeaux
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Centre Hospitalier Regional Universitaire Brest - Hopital Morvan
Brest
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Centre Hospitalier Universitaire De Caen
Caen
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Centre Hospitalier Universitaire De Clermont-ferrand
Clermont-Ferrand
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Centre Hospitalier Universitaire Dijon Bourgogne - Hopital D'enfants
Dijon
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Centre Hospitalier Universitaire De Grenoble
Grenoble
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Centre Hospitalier Universitaire De Limoges
Limoges
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Centre Hospitalier Regional Universitaire Montpellier - Hopital Arnaud-de-villeneuve
Montpellier
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Centre Hospitalier Universitaire De Nancy
Nancy
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Centre Hospitalier Universitaire De Nantes
Nantes
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Centre Hospitalier Universitaire De NICE
Nice
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Centre Hospitalier Universitaire De Poitiers
Poitiers
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Centre Hospitalier Universitaire De Rennes - Hopital Sud
Rennes
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Centre Hospitalier Universitaire De Rouen
Rouen
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Centre Hospitalier Universitaire Saint-etienne
Saint-Étienne
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Centre Hospitalier Universitaire De Toulouse - Hopital Des Enfants
Toulouse
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Centre Hospitalier Regional Universitaire De Tours - Hopital Clocheville
Tours
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Universitäts-Kinderspital beider
Basel
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Hug Hopitaux Universitaires De Geneve
Geneve
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Centre Hospitalier Universitaire Vaudois Chuv Lausanne
Lausanne
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Luzerner Kantonspital - Kinderspital Luzern
Lucerne
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University Children's Hospital Zurich
Zurich
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Royal Belfast Hospital for Sick Children
BT12 6BE Belfast
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Royal Aberdeen Children's Hospital
AB25 2ZG Aberdeen
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Aberdeen Royal Infirmary, NHS Grampian
AB25 2ZN Aberdeen
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Birmingham Children's Hospital NHS Foundation Trust
B4 6NH Birmingham
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University Hospitals Bristol NHS Foundation Trust
BS1 3NU Bristol
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Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
CB2 0QQ Cambridge
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Cardiff and Vale University Health Board, Noah's Ark Children's Hospital for Wales
CF14 4XW Cardiff
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NHS Lothian, Royal Hospital for Sick Children
EH9 1LF Edinburgh
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NHS Greater Glasgow and Clyde, The Royal Hospital for Children
G51 4TF Glasgow
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Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust
LS9 7TF Leeds
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Alder Hey Children's NHS Foundation Trust
L12 2AP Liverpool
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University College London Hospitals NHS Foundation Trust
NW1 2PG London
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The Royal Marsden NHS Foundation Trust
SW3 6JJ London
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Great Ormond Street Hospital For Children NHS Trust
WC1N 3JH London
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Royal Manchester Childrens' Hospital , Central Manchester University Hospitals NHS Foundation Trust
M13 9WL Manchester
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The Newcastle Upon Tyne Hospitals NHS Foundation Trust
NE7 7DN Newcastle
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Nottingham University Hospitals NHS Trust
NG7 2UH Nottingham
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John Radcliffe Hospital, Oxford Radcliffe Hospitals NHS Trust
OX3 9DU Oxford
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Sheffield Children's NHS Foundation Trust
S10 2TH Sheffield
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Southampton University Hospitals NHS Trust
SO16 6YD Southampton
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Alle anzeigen

Studien-Informationen

Detailed Description:

MyeChild 01 is an international phase III clinical trial in children with acute myeloid

leukaemia (AML); a disease with significant mortality. It will compare two induction

chemotherapy regimens: mitoxantrone and cytarabine (current standard treatment) with

liposomal daunorubicin and cytarabine. This will test liposomal daunorubicin, which is

believed to be less cardiotoxic than similar conventional drugs, although this is unproven.

(Randomisation 1 (R1) closed early to recruitment on 8th September 2017, due to liposomal

daunorubicin manufacturing issues resulting in unavailability of the drug.)

Patients responding well to induction chemotherapy are eligible for a randomisation of two

consolidation regimens: high dose cytarabine (current standard treatment) or fludarabine and

cytarabine (FLA); a regimen commonly used in patients with relapsed disease, testing whether

FLA is more effective in front line therapy than standard consolidation treatment. Patients

with cytogenetic features associated with a higher risk of relapse and those responding

sub-optimally to induction treatment are candidates for haemopoietic stem cell transplant

(HSCT) and are eligible for a randomisation comparing two HSCT conditioning regimens:

myeloablative conditioning (MAC) (current UNited Kingdom (UK) standard) or reduced intensity

conditioning (RIC). HSCT has not consistently shown benefit in high risk patients because the

mortality associated with the procedure has outweighed the advantage from a reduction in

relapse risk. This will test whether reducing the intensity of conditioning improves survival

by reducing transplant related deaths without increasing the relapse rate. The trial

incorporates a dose finding study for gemtuzumab ozogamicin. The aim is to identify the

optimum tolerated number of doses of gemtuzumab ozogamicin (up to a total of 3 doses), which

can be safely combined with either of the induction chemotherapy regimens and then to compare

this number of doses with one dose of gemtuzumab ozogamicin. The intensity of treatment will

be directed by cytogenetics/molecular genetics and response assessed by minimal residual

disease (MRD) levels measured by flow cytometry and molecular methodology.

Ein-/Ausschlusskriterien

Inclusion Criteria:

Inclusion criteria for trial entry

- Diagnosis of acute myeloid leukaemia (AML) /high risk Myelodysplastic syndrome (MDS)

(>10% blasts in the bone marrow)/isolated myeloid sarcoma (MS) (either de novo or

secondary).

- Age <18 years at trial entry.

- No prior chemotherapy or biological therapy for AML/high risk MDS/isolated MS other

than that permitted in the protocol.

- Normal cardiac function defined as fractional shortening ≥28% or ejection fraction

≥55%.

- Fit for protocol chemotherapy.

- Documented negative pregnancy test for female patients of childbearing potential.

- Patient agrees to use effective contraception (patients of child bearing potential).

- Written informed consent from the patient and/or parent/legal guardian.

Inclusion criteria for participation in the gemtuzumab ozogamicin dose finding study:

Centres must be formally activated in order to be take part in the embedded dose escalation

study. Please contact the trial office for further information.

- Patient meets the inclusion criteria for trial entry.

- Age:

- ≥12 months for the major dose finding study

- ≥ 12 weeks and <12 months for the minor dose finding study

- Normal renal function defined as calculated creatinine clearance ≥90ml/min/1.73m2.

- Normal hepatic function defined as total bilirubin ≤2.5 upper limit of normal (ULN)

for age unless it is caused by leukaemic involvement or Gilbert's syndrome or similar

disorder.

- Alanine transaminase (ALT) or aspartate transaminase (AST) ≤10 x ULN for age.

- Written informed consent from the patient and/or parent/legal guardian.

Inclusion criteria for treatment with gemtuzumab ozogamicin for patients not participating

in the gemtuzumab ozogamicin dose finding study or R2.

- Patient meets the inclusion criteria for trial entry (section 4.1.1)

- Age:

- ≥12 months

- ≥ 12 weeks

- ≥28 days and <12 weeks (patients will receive a maximum of one dose of gemtuzumab

ozogamicin)

- Normal renal function, defined as calculated creatinine clearance ≥90 ml/min/1.73m2

- Normal hepatic function, defined as total bilirubin ≤2.5 upper limit of normal (ULN)

for age and not due to leukaemic involvement or Gilbert's syndrome or similar disorder

- ALT or AST ≤10 x ULN for age

- Written informed consent from the patient and/or parent/legal guardian

Inclusion criteria for participation in R2.(once open to randomisation in the applicable

age group)

• Patient meets the inclusion criteria for trial entry

Patient age:

- ≥12 months

- ≥12 weeks (once R2 open in patients aged ≥12 weeks and <12 months)

- Normal renal function defined as calculated creatinine clearance ≥90ml/min/1.73m2.

- Normal hepatic function defined as total bilirubin ≤2.5 ULN for age and not due to

leukaemic involvement or Gilbert's syndrome or similar disorder.

- ALT or AST ≤10 x ULN for age.

- Written informed consent from the patient and/or parent/legal guardian.

Inclusion criteria for participation in R3.

- Patient meets the inclusion criteria for trial entry

- Induction treatment as per MyeChild 01 protocol or treated with 2 courses of

mitoxantrone & cytarabine off trial.

- Minimal residual disease (MRD) response (performed in MyeChild 01 centralised

laboratories, see national MyeChild 01 Laboratory Manual):

- Patients with good risk cytogenetics/molecular genetics and a MRD level <0.1% by

flow after course 2, or a decrease in transcript levels of >3 logs after course 2

for those with an informative molecular marker, but without an informative marker

of sufficient sensitivity for flow MRD monitoring or

- Patients with intermediate risk cytogenetics/molecular genetics with a MRD level

<0.1% by flow after course 1 and course 2, or a decrease in transcript levels of

>3 logs after course 1 and course 2 for those with an informative molecular

marker, but without an informative marker of sufficient sensitivity for flow MRD

monitoring.

- Written informed consent from the patient and/or parent/legal guardian.

Inclusion criteria for participation in R4.

- Patient meets the inclusion criteria for trial entry

- Induction treatment as per MyeChild 01 protocol or treated with 1 or 2 courses of

mitoxantrone & cytarabine ± treatment intensification with fludarabine, cytarabine &

idarubicin (FLA-Ida) off trial.

- Patient is in complete remission (CR) or CR with incomplete blood count recovery (CRi)

defined as <5% blasts confirmed by flow cytometry/ molecular/FISH in a bone marrow

aspirate taken within 6 weeks prior to randomisation to R4.

- Patient meets one of the following criteria and is a candidate for HSCT as per the

protocol:

- High risk after course 1 (all patients with poor risk cytogenetics and patients

with intermediate risk cytogenetics who fail to achieve CR/CRi).

- Intermediate risk cytogenetics with MRD >0.1% after course 1 and 2 measured by

flow. If no flow MRD marker of sufficient sensitivity is identified, a molecular

MRD marker with a sensitivity of >0.1% may be used.

- Good risk cytogenetics with flow MRD >0.1% confirmed by a decrease in molecular

MRD of <3 logs or rising transcript levels after course 3 despite treatment

intensification (FLA-Ida) and after discussion with the Clinical Co-ordinators.

- Availability of a 9-10/10 human leukocyte antigen (HLA) matched family or unrelated

donor or 5-8/8 matched cord blood unit with an adequate cell dose as defined by the

protocol section 17.1.

- Written informed consent from the patient and/or parent/legal guardian.

Exclusion Criteria:

Exclusion criteria for all randomisations

- Acute Promyelocytic Leukaemia.

- Myeloid Leukaemia of Down Syndrome.

- Blast crisis of chronic myeloid leukaemia.

- Relapsed or refractory AML.

- Bone marrow failure syndromes.

- Prior anthracycline exposure which would inhibit the delivery of study anthracyclines.

- Concurrent treatment or administration of any other experimental drug or with any

other biological therapy for AML/high risk MDS/isolated MS.

- Pregnant or lactating females.

Studien-Rationale

Primary outcome:

1. Incidence of dose limiting toxicities (DLTs). (Time Frame - Incidence of DLTs will be evaluated up to day 45 post course 1 and course 2 of induction chemotherapy.)

2. Event Free Survival (EFS). (Time Frame - Event free survival (EFS) will be evaluated as the time from randomisation one to the first event, up to 16 years.):
The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. EFS estimates will be presented at 24 months along with 95% confidence intervals.

3. Event Free Survival (EFS). (Time Frame - Event free survival (EFS) will be evaluated as the time from randomisation two to the first event, up to 16 years..):
The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. EFS estimates will be presented at 24 months along with 95% confidence intervals.

4. Relapse free survival (RFS). (Time Frame - Relapse free survival (RFS) will be evaluated as the time of randomisation three to the first relapse or death from any cause, up to 16 years.):
The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. RFS estimates will be presented at 24 months along with 95% confidence intervals.

5. Early treatment related adverse reactions. (Time Frame - Early treatment related adverse reactions will be evaluated at day 100 post-transplant.):
Early treatment related adverse reactions defined as the incidence by day 100 post-transplant of grade 3-5 toxicity for the following systems using the National Cancer Institute (NCI) Common Terminology Criteria v4: Cardiac (pericardial effusion/Left ventricular systolic dysfunction). Respiratory, thoracic and mediastinal (hypoxia/pneumonitis). Gastrointestinal (GI) (diarrhoea/typhlitis/upper and lower GI haemorrhage). Investigations (bilirubin). Renal and Urinary (acute kidney injury/haematuria). Nervous system (seizure).

6. Relapse free survival (RFS). (Time Frame - Relapse free survival (RFS) will be evaluated as the time of randomisation four to the first relapse or death from any cause, up to 16 years.):
The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. RFS estimates will be presented at 12 months along with 95% confidence intervals.

Secondary outcome:

1. The nature, incidence and severity of adverse events (AEs) (gemtuzumab ozogamicin dose finding study). (Time Frame - Evaluated by day 45 post course 1 and course 2.)

2. Response measured by bone marrow assessment using morphology and minimal residual disease (MRD) assessment (gemtuzumab ozogamicin dose finding study). (Time Frame - Evaluated by day 45 post course 1 and course 2.):
Response is assessed by morphology confirmed by MRD levels measured by flow cytometry, molecular methods or fluorescence in situ hybridisation (FISH) as defined in the protocol, in combination with platelet and neutrophil counts. These results of these assessments will be combined to determine the patient's disease response using the response criteria defined in the protocol.

3. Serum pharmacokinetic (PK) parameters of gemtuzumab ozogamicin: Clearance (CL) (gemtuzumab ozogamicin dose finding study) (Time Frame - Evaluated up to one month after the first dose of gemtuzumab ozogamicin.):
Serum PK parameters will be measured using serial samples taken at multiple timepoints during course 1 and at 1 month post first dose of gemtuzumab ozogamicin as defined in the protocol by dose cohort.

4. Serum pharmacokinetic (PK) parameters of gemtuzumab ozogamicin: Volume of distribution (Vd) (gemtuzumab ozogamicin dose finding study) (Time Frame - Evaluated up to one month after the first dose of gemtuzumab ozogamicin.):
Serum PK parameters will be measured using serial samples taken at multiple timepoints during course 1 and at 1 month post first dose of gemtuzumab ozogamicin as defined in the protocol by dose cohort.

5. Complete remission (CR) (R1 & R2). (Time Frame - Evaluated and presented at the completion of course 1 and 2 of treatment up to a maximum of 45 days post each course of treatment):
Evaluated using remission status at completion of course 1 and course 2.

6. Reasons for failure to achieve CR (R1 & R2). (Time Frame - Evaluated and presented at the completion of course 1 and 2 of treatment, up to a maximum of 45 days post each course of treatment.):
Evaluated as resistant disease, induction death or not evaluable.This will be evaluated at completion of course 1 and 2 of treatment, once patient's blood counts have recovered or reason for non-recovery has been determined.

7. Cumulative Incidence of Relapse (CIR) (all randomisations). (Time Frame - Evaluated as time from randomisation to the relevant question to relapse, up to 16 years.):
The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. CIR estimates will be presented at 24 months along with 95% confidence intervals for randomisations 1, 2 and 3, and at 12 months for randomisation 4.

8. Death in CR (DCR) (R1, R2 & R3). (Time Frame - Evaluated as time from randomisation to relevant question to date of death from any cause in patients who have achieved CR, up to 16 years.):
The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. DCR estimates will be presented at 24 months along with 95% confidence intervals.

9. Event Free Survival (EFS) (R1, R2 & R3). (Time Frame - Evaluated as time from randomisation to the relevant question to the first of failure to achieve CR (recorded as an event on day 1), relapse, secondary malignancy or death from any cause, up to 16 years.):
The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. EFS estimates will be presented at 24 months along with 95% confidence intervals.

10. Overall Survival (OS) (all randomisations). (Time Frame - Evaluated as time from randomisation to the relevant question to death from any cause or date last seen for patients who are alive at the end of the trial, up to 16 years.):
The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. OS estimates will be presented at 24 months along with 95% confidence intervals for randomisations 1, 2 and 3, and at 12 months for randomisation 4.

11. Incidence of toxicities (all randomisations). (Time Frame - Evaluated 30 days after end of trial treatment.)

12. Incidence of cardiotoxicity (R1, R2 & R4 only). (Time Frame - Evaluated 30 days after end of trial treatment.)

13. Incidence of bilirubin of grade 3 of higher (R2 & R4 only). (Time Frame - Evaluated 30 days after end of trial treatment.)

14. Incidence of Veno-Occlusive Disease (R2 & R4 only). (Time Frame - Evaluated 30 days after end of trial treatment.)

15. Minimal Residual Disease (MRD) clearance after course 1 & 2 (R1 & R2 only). (Time Frame - Evaluated and presented at completion of course 1 and 2 of treatment, up to a maximum of 45 days post each course of treatment.):
Evaluated using MRD result at completion of course 1 and 2 once patient's blood counts have recovered or reason for non-recovery has been determined.

16. Time to haematological recovery (all randomisations). (Time Frame - Evaluated by day 45 post course 1 and course 2.):
Evaluated using the date of haematological recovery (platelets to >=80 x 10^9/L, and neutrophils to >=1.0 x 10^9/L). The primary analysis will be carried out once the last patient has a minimum of 1 year follow up. Time to haematological recovery estimates will be presented at 45 days post course 1 and course 2 of treatment along with 95% confidence intervals.

17. Days in hospital after each course of treatment (all randomisations). (Time Frame - Evaluated once all patients have completed trial treatment.):
Total number of days spent in hospital for each course of treatment, collected from date of randomisation until count recovery after final course of treatment, up to a maximum of 45 days post the final course of treatment. This will be summarised per course of treatment.

18. Incidence of mixed chimerism at day 100 post-transplant (R4 only). (Time Frame - Evaluated at day 100 post-transplant.)

19. Treatment Related Mortality (TRM) (R4 only). (Time Frame - Evaluated as time in days between randomisation to R4 and death which is unrelated to the underlying disease and considered related to the transplant procedure.):
The primary analysis will be carried out once the last patient has a minimum of 1 year follow up which is estimated to be 7 years after the start of recruitment. TRM estimates will be presented at 12 months along with 95% confidence intervals.

20. Gonadal function (R4 only). (Time Frame - Evaluated at 1 year post-transplant and at the end of follow-up, which is estimated to be through to study completion, an average timeframe of 10 years.):
The method of assessment will be by scale (Tanner scale) and physiological parameters. This will be evaluated at 1 year post-transplant and at the end of study follow-up.

Studien-Arme

  • Active Comparator: Mitoxantrone
    Course 1 Mitoxantrone: 12 mg/m2 daily by IV infusion over 1 hour on days 1, 2, 3 and 4 (total 4 doses). Cytarabine:100 mg/m2 12 hourly by IV bolus on days 1-10 inclusive (total 20 doses). Course 2 Mitoxantrone: 12 mg/m2 daily by IV infusion over 1 hour on days 1, 2 and 3 (total 3 doses). Cytarabine: 100 mg/m2 12 hourly by IV bolus on days 1-8 inclusive (total 16 doses).
  • Experimental: Liposomal daunorubicin
    Randomisation 1 (R1)) closed early to recruitment on 8th September 2017, due to liposomal daunorubicin manufacturing issues resulting in unavailability of the drug. Course 1 Liposomal daunorubicin: 80 mg/m2 daily by 1 hour IV infusion on days 1, 3 and 5 (total 3 doses). Cytarabine: 100 mg/m2 12 hourly by IV bolus on days 1-10 inclusive (total 20 doses). Course 2 Liposomal daunorubicin: 60 mg/m2 daily by 1 hour IV infusion on days 1, 3 and 5 (total 3 doses). Cytarabine: 100 mg/m2 12 hourly by IV bolus on days 1-8 inclusive (total 16 doses).
  • Experimental: Gemtuzumab Ozogamicin Dose Finding Study
    Cohort 1: 1x3mg/m2 IV infusion over 2hours on day 4. Cohort 2: 2x3mg/m2 IV infusion over 2hours on day 4 and day 7. Cohort 3: 3x3mg/m2 IV infusion over 2hours on days 4, 7 and 10.
  • Active Comparator: High dose cytarabine
    Two courses of Cytarabine: 3 g/m2 12 hourly by IV infusion over 4 hours on days 1, 3 and 5 (total 6 doses).
  • Experimental: Fludarabine & cytarabine
    Two courses of: Fludarabine: 30 mg/m2 daily by IV infusion over 30 minutes on days 1-5 inclusive (total 5 doses). Cytarabine: 2 g/m2 daily by IV infusion over 4 hours on days 1-5 inclusive (total 5 doses).The cytarabine infusion should be started 4 hours after the start of the fludarabine infusion
  • Active Comparator: Myeloablative conditioning
    Busulfan Area Under the Curve (AUC) 70-100mg/L x hr by IV infusion over 3 hours, given 12 hourly on days -10 to -7 (8 doses). Cyclophosphamide 50mg/kg/day by IV infusion over 1 hour, on days -5 to -2 (4 doses).
  • Experimental: Reduced intensity conditioning
    Busulfan AUC60-65mg/L X hr by IV infusion over 3 hours, given 12 hourly on days -5 to -2 (8 doses). Fludarabine 30mg/m2/day by IV infusion over 30 minutes on days -8 to -3 (6 doses).

Geprüfte Regime

  • Gemtuzumab ozogamicin (Mylotarg):
    Antibody-conjugated chemotherapy agent.
  • 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.
  • Mitoxantrone:
    DNA-reactive agent
  • Fludarabine:
    A water-soluble fluorinated nucleotide analogue of the antiviral agent vidarabine.
  • Cytarabine:
    Pyrimidine nucleoside analogue, an antineoplastic agent.
  • Busulfan:
    Alkylsulfonate
  • Cyclophosphamide:
    A nitrogen mustard alkylating agent from the oxazaphosphorine group

Quelle: ClinicalTrials.gov


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