Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT00002517|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 22, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes||Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: idarubicin Drug: mitoxantrone hydrochloride Drug: thioguanine Procedure: allogeneic bone marrow transplantation Radiation: radiation therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||IDA VS MTZ IN INDUCTION AND INTENSIFICATION TREATMENT OF AML OR MDS IN CHILDREN, A PHASE III RANDOMIZED STUDY|
|Study Start Date :||March 1993|
|Actual Primary Completion Date :||May 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002517
|Algemeen Ziekenhuis Middelheim|
|Antwerp, Belgium, 2020|
|Hopital Universitaire Des Enfants Reine Fabiola|
|Brussels, Belgium, 1020|
|Academisch Ziekenhuis der Vrije Universiteit Brussel|
|Brussels, Belgium, 1090|
|Universitair Ziekenhuis Gent|
|Ghent, Belgium, B-9000|
|Leuven, Belgium, B-3000|
|Centre Hospitalier Regional de la Citadelle|
|Liege, Belgium, 4000|
|Clinique de l'Esperance|
|Montegnee, Belgium, 4420|
|Centre Hospitalier Regional et Universitaire d'Angers|
|Angers, France, 49033|
|CHR de Besancon - Hopital Saint-Jacques|
|Besancon, France, 25030|
|CHU de Caen|
|Caen, France, 14033|
|CHR de Grenoble - La Tronche|
|Grenoble, France, 38043|
|Centre Hospitalier Regional de Lille|
|Lille, France, 59037|
|Lyon, France, 69322|
|Hopital Arnaud de Villeneuve|
|Montpellier, France, 34295|
|CHR Hotel Dieu|
|Nantes, France, 44093|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Hopital Robert Debre|
|Paris, France, 75019|
|Institut Curie - Section Medicale|
|Paris, France, 75248|
|Hopital Jean Bernard|
|Poitiers, France, 86021|
|Reims, France, 51092|
|Hopital Universitaire Hautepierre|
|Strasbourg, France, 67098|
|Hopital des Enfants (Purpan Enfants)|
|Toulouse, France, 31026|
|Hospital Escolar San Joao|
|Porto, Portugal, 4200|
|Study Chair:||Catherine Behar, MD||Hopital Americain|