AzTrials
AzTrials

LeukemiaPhase 3NCT00002517

Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome

A Phase 3 study testing cytarabine, daunorubicin hydrochloride and dexamethasone in people with Leukemia and Myelodysplastic Syndromes, run by European Organisation for Research and Treatment of Cancer - EORTC at 23 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for acute myeloid leukemia or myelodysplastic syndrome. Read more about this study

Who is it for?
Ages Up to 14 years
Conditions the study is for
Leukemia, Myelodysplastic Syndromes
What is being tested?
cytarabine, daunorubicin hydrochloride and dexamethasone
Type of treatment
Surgery or procedure
How many people
Not given
Where
23 sitesin 3 countries
Study dates
Mar 1993to May 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 14 years
  • All sexes
  • No healthy volunteers
  • Child

DISEASE CHARACTERISTICS:

  • Newly diagnosed acute myeloid leukemia (AML) based on the cytological, cytochemical, and immunological criteria of the FAB classification
  • Must meet 1 of the following criteria:
  • More than 30% blasts in marrow (calculation based on the total number of nucleated cells except lymphocytes and plasmocytes)
  • Presence of granulocytic sarcoma (chloroma)
  • Disease must be associated with at least 1 of the following:
  • More than 3% myeloperoxidase- or Sudan black-positive blasts
  • More than 3% platelet peroxidase-positive blasts
  • More than 20% esterase-positive blasts
  • Immunological markers compatible with a myeloid differentiation, including 1 of the following criteria:
  • Blasts positive for myeloid-associated antigen and negative for B- or T-lymphocyte antigens
  • Blasts positive for at least 2 myeloid antigens (except CD3 and CD8)
  • A cytogenetic abnormality associated with AML OR
  • Newly diagnosed myelodysplastic syndrome (MDS) based on the cytological and cytochemical criteria of the FAB classification
  • Eligible subtypes:
  • Refractory anemia with excess blasts (RAEB)
  • RAEB in transformation
  • Chronic myelomonocytic leukemia
  • No promyelocytic leukemia (M3 or M3v) treated with tretinoin (protocol EORTC-06915)
  • No AML secondary to hematologic or malignant disease other than MDS
  • Registration must occur within 48 hours of diagnosis

PATIENT CHARACTERISTICS:

Age:

  • Under 15

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics
  • No uncontrolled bleeding disorder

Hepatic:

  • Not specified

Renal:

  • No renal failure

Cardiovascular:

  • No congenital heart disease

Other:

  • No encephalopathy
  • No genetic disorders
  • No uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No prior antileukemic therapy

Trial locations and contacts

23 sites in 3 countries.

23 sites in 3 countries

France15 sites

  • Centre Hospitalier Regional et Universitaire d'Angers

    Angers, 49033

  • CHR de Besancon - Hopital Saint-Jacques

    Besançon, 25030

  • CHU de Caen

    Caen, 14033

  • CHR de Grenoble - La Tronche

    Grenoble, 38043

  • Centre Hospitalier Regional de Lille

    Lille, 59037

  • Hopital Debrousse

    Lyon, 69322

  • Hopital Arnaud de Villeneuve

    Montpellier, 34295

  • CHR Hotel Dieu

    Nantes, 44093

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hopital Robert Debre

    Paris, 75019

  • Institut Curie - Section Medicale

    Paris, 75248

  • Hopital Jean Bernard

    Poitiers, 86021

  • Hopital Americain

    Reims, 51092

  • Hopital Universitaire Hautepierre

    Strasbourg, 67098

  • Hopital des Enfants (Purpan Enfants)

    Toulouse, 31026

Other trials in France

Belgium7 sites

  • Algemeen Ziekenhuis Middelheim

    Antwerp, 2020

  • Hopital Universitaire Des Enfants Reine Fabiola

    Brussels, 1020

  • Academisch Ziekenhuis der Vrije Universiteit Brussel

    Brussels, 1090

  • Universitair Ziekenhuis Gent

    Ghent, B-9000

  • U.Z. Gasthuisberg

    Leuven, B-3000

  • Centre Hospitalier Regional de la Citadelle

    Liège, 4000

  • Clinique de l'Esperance

    Montegnée, 4420

Other trials in Belgium

Portugal1 site

  • Hospital Escolar San Joao

    Porto, 4200

Other trials in Portugal

About this study

Official title: IDA VS MTZ IN INDUCTION AND INTENSIFICATION TREATMENT OF AML OR MDS IN CHILDREN, A PHASE III RANDOMIZED STUDY

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for acute myeloid leukemia or myelodysplastic syndrome.

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have newly diagnosed acute myeloid leukemia or myelodysplastic syndrome.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of idarubicin vs mitoxantrone in induction and first intensification in terms of achieving and maintaining complete remissions in children with acute myeloid leukemia or myelodysplastic syndrome.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and disease type (de novo acute myeloid leukemia (AML) vs AML secondary to myelodysplastic syndrome (MDS) vs MDS).

  • Induction: Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive cytarabine (ARA-C) IV continuously on days 1 and 2 and then IV over 30 minutes every 12 hours on days 3-8, mitoxantrone IV on days 3-5, etoposide (VP-16) IV over 1 hour on days 6-8, and ARA-C intrathecally (IT) on days 1 and 8.
  • Arm II: Patients receive ARA-C and VP-16 as in arm I and idarubicin IV on days 3-5.

Patients on both arms with CNS disease at presentation receive ARA-C IT every 3 days until the CSF clears and then weekly until the first intensification. After induction, patients on both arms proceed to first intensification, regardless of response.

  • First intensification: When blood counts recover and within 40 days after initiating induction, patients are randomized to 1 of 2 treatment arms.
  • Arm III: Patients receive high-dose ARA-C IV over 3 hours every 12 hours on days 1-3 (if allogeneic bone marrow transplantation (BMT) is planned) or days 1-4 (if allogeneic BMT is not planned) and mitoxantrone IV on days 7-9.
  • Arm IV: Patients receive high-dose ARA-C as in arm III and idarubicin IV on days 7-9.
  • Patients who achieve complete remission (CR) after first intensification and have an HLA-identical, chronic myelomonocytic leukemia-nonreactive, sibling donor undergo allogeneic BMT. Patients who achieve CR after intensification and have no suitable donor receive intensive chemotherapy as defined below. All patients with chloroma at presentation undergo local radiotherapy beginning after final intensification.
  • Second intensification: When blood counts recover, patients receive daunorubicin IV continuously, ARA-C IV continuously, VP-16 IV continuously, oral thioguanine, and oral dexamethasone on days 1-4 and 11-14 and ARA-C IT on days 1, 4, 11, and 14.
  • Third intensification: When blood counts recover, patients receive high-dose ARA-C IV over 3 hours every 12 hours on days 1-3 and VP-16 IV over 1 hour on days 2-5. When blood counts recover, autologous bone marrow is harvested in the event of subsequent relapse.
  • Maintenance: When blood counts recover, patients receive oral thioguanine daily and ARA-C subcutaneously 4 days a month for 1 year.

PROJECTED ACCRUAL: A total of 310 patients will be accrued for this study within 5 years.

Being tested
cytarabine, daunorubicin hydrochloride, dexamethasone, etoposide, idarubicin
Keywords
childhood myelodysplastic syndromes, untreated childhood acute myeloid leukemia and other myeloid malignancies, childhood acute myeloblastic leukemia without maturation (M1), childhood acute myeloblastic leukemia with maturation (M2), childhood acute myelomonocytic leukemia (M4), childhood acute monoblastic leukemia (M5a), childhood acute monocytic leukemia (M5b), childhood acute erythroleukemia (M6), childhood acute megakaryocytic leukemia (M7), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, childhood acute minimally differentiated myeloid leukemia (M0)
Medical subject headings
Leukemia, Myelodysplastic Syndromes, Anemia, Refractory, with Excess of Blasts, Leukemia, Myelomonocytic, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cytarabineDrug

  • daunorubicin hydrochlorideDrug

  • dexamethasoneDrug

  • etoposideDrug

  • idarubicinDrug

  • mitoxantrone hydrochlorideDrug

  • thioguanineDrug

  • allogeneic bone marrow transplantationProcedure or surgery

  • radiation therapyRadiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMar 1993
  3. Primary completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002517
Sponsor's protocol ID
CDR0000078212
Other IDs
EORTC-58921
Status last verified
Dec 2002
First submitted
1 Nov 1999
Last updated
22 Jun 2010
Results posted
No

Publications

  • Brunet AS, Ploton C, Galambrun C, Pondarre C, Pages MP, Bleyzac N, Freydiere AM, Barbe G, Bertrand Y. Low incidence of sepsis due to viridans streptococci in a ten-year retrospective study of pediatric acute myeloid leukemia. Pediatr Blood Cancer. 2006 Nov;47(6):765-72. doi: 10.1002/pbc.20706.

    PubMed 16333838

  • Entz-Werle N, Suciu S, van der Werff ten Bosch J, Vilmer E, Bertrand Y, Benoit Y, Margueritte G, Plouvier E, Boutard P, Vandecruys E, Ferster A, Lutz P, Uyttebroeck A, Hoyoux C, Thyss A, Rialland X, Norton L, Pages MP, Philippe N, Otten J, Behar C; EORTC Children Leukemia Group. Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogeneic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group report. Leukemia. 2005 Dec;19(12):2072-81. doi: 10.1038/sj.leu.2403932.

    PubMed 16136166

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cytarabine, daunorubicin hydrochloride and dexamethasone in people with Leukemia and Myelodysplastic Syndromes, run by European Organisation for Research and Treatment of Cancer - EORTC at 23 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in France, Belgium, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002517, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2010.

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