Clinical trial · Interventional

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

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

NCT00002517CI-TRIAL-00003586completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS	0.90

Interventions

Interventions (9)

Intervention	Type	Mapped drug	Match
allogeneic bone marrow transplantation	Procedure	—	UNRESOLVED
cytarabine	Drug	Cytarabine	ALIAS
daunorubicin hydrochloride	Drug	Daunorubicin	ALIAS
dexamethasone	Drug	Dexamethasone	ALIAS
etoposide	Drug	Etoposide	ALIAS
idarubicin	Drug	Idarubicin	ALIAS
mitoxantrone hydrochloride	Drug	Mitoxantrone	ALIAS
radiation therapy	Radiation	—	UNRESOLVED

Eligibility

Eligibility (as posted)

Sex: All
Maximum age: 14 Years

Show eligibility criteria text

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

References

Publications (2)

RESULTBrunet 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. PMID 16333838
RESULTEntz-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. PMID 16136166

Registry

Dates and enrollment

Start: Mar 1, 1993
Primary completion: May 1, 2010
Completion: —
First posted: Jan 27, 2003
Last update posted: Jun 22, 2010
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC NETWORK
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)

Data updated 22 days agoSource updated Jun 22, 2010source: clinicaltrials

Locations

Locations by country (23)

Country	Sites	Recruiting
France	15	0
Belgium	7	0