Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome
- Conditions
- LeukemiaMyelodysplastic Syndromes
- Registration Number
- NCT00002517
- Brief 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.
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Centre Hospitalier Regional et Universitaire d'Angers
🇫🇷Angers, France
Algemeen Ziekenhuis Middelheim
🇧🇪Antwerp, Belgium
Hopital Universitaire Des Enfants Reine Fabiola
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Gent
🇧🇪Ghent, Belgium
CHR de Grenoble - La Tronche
🇫🇷Grenoble, France
CHU de Caen
🇫🇷Caen, France
Academisch Ziekenhuis der Vrije Universiteit Brussel
🇧🇪Brussels, Belgium
Centre Hospitalier Regional de la Citadelle
🇧🇪Liege, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Clinique de l'Esperance
🇧🇪Montegnee, Belgium
CHR de Besancon - Hopital Saint-Jacques
🇫🇷Besancon, France
Centre Hospitalier Regional de Lille
🇫🇷Lille, France
Hopital Arnaud de Villeneuve
🇫🇷Montpellier, France
CHR Hotel Dieu
🇫🇷Nantes, France
Hopital Debrousse
🇫🇷Lyon, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Hopital Robert Debre
🇫🇷Paris, France
Hopital Jean Bernard
🇫🇷Poitiers, France
Institut Curie - Section Medicale
🇫🇷Paris, France
Hopital des Enfants (Purpan Enfants)
🇫🇷Toulouse, France
Hopital Americain
🇫🇷Reims, France
Hopital Universitaire Hautepierre
🇫🇷Strasbourg, France
Hospital Escolar San Joao
🇵🇹Porto, Portugal