Research study for treatment of children and adolescents with acute myeloid leukaemia 0-18 years

NOPHO-DBH AML 2012 Protocol Research study for treatment of children and adolescents with acute myeloid leukaemia 0-18 years - AML 2012

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002934-35-SE

Enrollment

325

Registered

2012-10-30

Start date

2013-01-22

Completion date

Unknown

Last updated

2019-01-07

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

Conditions

Acute myeloid leukemia MedDRA version: 20.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864

Interventions

Trade Name: Fludarabin Actavis Pharmaceutical Form: Powder for infusion INN or Proposed INN: FLUDARABINE PHOSPHATE CAS Number: 75607-67-9 Concentration unit: mg/ml milligram(s)/millilitre Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) AML as defined by the diagnostic criteria in the protocol 2) Age =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Previous chemotherapy or radiotherapy. This includes patient with secondary AML after previous cancer therapy. They can be treated according to the protocol but will not be included in the study population. Secondary AML has a poorer response to chemotherapy but may benefit from SCT if the procedure can be tolerated. 2) AML secondary to previous bone marrow failure syndrome. 3) Down syndrome (DS). Patients with myeloid leukaemia of Down syndrome are recommended to be treated according to the international ML-DS protocol. Patients with AML and DS older than 5 years who often lack GATA1 mutation and do not have typical myeloid leukaemia of DS may be treated according to the protocol but will not be included in the study population. 4) Acute promyelocytic leukaemia (APL). These patients are recommended treatment according to the international APL Study. 5) Myelodysplastic syndrome (MDS). These patients are recommended treatment according to EWOG-MDS. 6) Juvenile Myelomonocytic Leukaemia (JMML). These patients are recommended treatment according to EWOG-MDS. 7) Known intolerance to any of the chemotherapeutic drugs in the protocol. 8) Fanconi anaemia. 9) Major organ failure precluding administration of planned chemotherapy. 10) Positive pregnancy test . 11) Lactating female or female of childbearing potential not using adequate contraception.

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Aim 1 and 3. At day 22 after course 1. Aim 2 and 3. At day 22 after course 2 and immediately prior to the third course (6-8 weeks from diagnosis) ;Main Objective: The AML 2012 study is a treatment and research protocol with the overall aim of improving prognosis for children and adolescents with AML. This is to be achieved by better risk stratification based on MRD quantification and more intensive induction compared to previous NOPHO protocols. Specific research aims are 1) To investigate if DaunoXome® has a higher efficacy than Mitoxantrone, when given in course 1 for treatment of pediatric AML 2) To investigate if FLADx has a higher efficacy than ADxE when given as the second induction course for treatment of pediatric AML 3) To investigate the correlation between MRD measurement by PCR and flow cytometry and the prognostic impact of MRD with either method after course 1 and 2 respectively. ;Secondary Objective: The protocol will compare the efficacy and toxicity of the treatment between the randomised arms and with the previous NOPHO-AML protocols with the aims of 1) Improving both EFS and OS as compared to NOPHO-AML 93 and 2004. 2) Improving EFS and OS for patients with intermediate response (5-14.9%) blasts after course 1 and patients with t(8;21). 3) Achieving improved anti-leukaemic effect with no increase or a decrease in early toxic deaths and deaths in CR. 4) Comparing outcome in subgroups of patients as defined by characteristics of both patients and disease such as age, FAB type and cytogenetics (e.g. t(8;21, inv(16) and MLL rearrangements). 5) Compare the incidence of severe infections and severe organ toxicity in the treatment arms and with previous protocols ;Primary end point(s): 1) The fraction of patients who achieve an MRD level below 0.1%, as quantified by flow cytometry, after the first induction course. (aim 1) 2) The fraction of patients who achieve an MRD level below 0.1%, as quantified by flow	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Aim 1 and 3. At day 22 after course 1. Aim 2 and 3. At day 22 after course 2 and immediately prior to the third course (6-8 weeks from diagnosis) ;Main Objective: The AML 2012 study is a treatment and research protocol with the overall aim of improving prognosis for children and adolescents with AML. This is to be achieved by better risk stratification based on MRD quantification and more intensive induction compared to previous NOPHO protocols. Specific research aims are 1) To investigate if DaunoXome® has a higher efficacy than Mitoxantrone, when given in course 1 for treatment of pediatric AML 2) To investigate if FLADx has a higher efficacy than ADxE when given as the second induction course for treatment of pediatric AML 3) To investigate the correlation between MRD measurement by PCR and flow cytometry and the prognostic impact of MRD with either method after course 1 and 2 respectively. ;Secondary Objective: The protocol will compare the efficacy and toxicity of the treatment between the randomised arms and with the previous NOPHO-AML protocols with the aims of 1) Improving both EFS and OS as compared to NOPHO-AML 93 and 2004. 2) Improving EFS and OS for patients with intermediate response (5-14.9%) blasts after course 1 and patients with t(8;21). 3) Achieving improved anti-leukaemic effect with no increase or a decrease in early toxic deaths and deaths in CR. 4) Comparing outcome in subgroups of patients as defined by characteristics of both patients and disease such as age, FAB type and cytogenetics (e.g. t(8;21, inv(16) and MLL rearrangements). 5) Compare the incidence of severe infections and severe organ toxicity in the treatment arms and with previous protocols ;Primary end point(s): 1) The fraction of patients who achieve an MRD level below 0.1%, as quantified by flow cytometry, after the first induction course. (aim 1) 2) The fraction of patients who achieve an MRD level below 0.1%, as quantified by flow

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Secondary

Measure	Time frame
Secondary end point(s): 1. Event-free survival and overall survival at five years. 2. The median MRD after course 1 and course 2. 3. The rate of CR after one and two induction courses. 4. Cardiac function after one and five years. 5. Frequency of severe adverse events as defined in 14.2.3, early death and death in CR.;Timepoint(s) of evaluation of this end point: 1) Five years from diagnosis or at time of event. 2) Within 6-8 weeks from diagnosis 3) Within 6-8 weeks from diagnosis 4) One and five years from diagnosis 5) After each course (every 3-4 weeks for five courses) and cumulative within five years	—

Measure

Time frame

Secondary end point(s): 1. Event-free survival and overall survival at five years. 2. The median MRD after course 1 and course 2. 3. The rate of CR after one and two induction courses. 4. Cardiac function after one and five years. 5. Frequency of severe adverse events as defined in 14.2.3, early death and death in CR.;Timepoint(s) of evaluation of this end point: 1) Five years from diagnosis or at time of event. 2) Within 6-8 weeks from diagnosis 3) Within 6-8 weeks from diagnosis 4) One and five years from diagnosis 5) After each course (every 3-4 weeks for five courses) and cumulative within five years

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Countries

Denmark, Finland, Hong Kong, Netherlands, Norway, Spain, Sweden

Contacts

Public ContactBarncancerforskningscentrum

Västra Götaland regionen

jonas.abrahamsson@vgregion.se46313434000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026