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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome  Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome
Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome
For Condition: Myeloid Leukemia,Myelodysplastic Syndromes,Refractory Anemia
Status: No longer recruiting
Sponsor(s): EORTC Children's Leukemia Cooperative Group ,
Synopsis: 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.
Details: 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). - 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. - 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. - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /14 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CatherineBehar, Study Chair, Hopital Americain
CHR de Besancon - Hopital Saint-Jacques
Besancon, , 25030
France
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Centre Hospitalier Regional de Lille
Lille, , 59037
France
CHU de Caen
Caen, , 14033
France
Centre Hospitalier Regional et Universitaire d'Angers
Angers, , 49033
France
Hopital Universitaire Hautepierre
Strasbourg, , 67098
France
Hopital Americain
Reims, , 51092
France
Hopital Robert Debre
Paris, , 75019
France
Hopital Debrousse
Lyon, , 69322
France
Centre Hospitalier Regional de la Citadelle
LIEGE, , 4000
Belgium
Algemeen Ziekenhuis Middelheim
Antwerp, , 2020
Belgium
Centre Antoine Lacassagne
Nice, , 06189
France
Hospital Escolar San Joao
Porto, , 4200
Portugal
Hopital Arnaud de Villeneuve
Montpellier, , 34295
France
Clinique de l'Esperance
Montegnee, , 4420
Belgium
Hopital Jean Bernard
Poitiers, , 86021
France
Hopital Universitaire Des Enfants Reine Fabiola
Brussels, , 1020
Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, , 1090
Belgium
Institut Curie - Section Medicale
Paris, , 75248
France
Hopital des Enfants (Purpan Enfants)
Toulouse, , 31026
France
Universitair Ziekenhuis Gent
Ghent, , B-9000
Belgium
CHR Hotel Dieu
Nantes, , 44093
France
CHR de Grenoble - La Tronche
Grenoble, , 38043
France
Additional Information:
Study ID Numbers: CDR0000078212; EORTC-58921
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002517
Other Refractory Anemia Studies:
1. Decitabine Compared With Supportive Care in Treating Patients With Advanced Myelodysplastic Syndromes
2. Daclizumab Compared With Antithymocyte Globulin in Treating Cytopenia in Patients With Myelodysplastic Syndromes
3. Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome
4. Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
5. Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome
Related Studies:
Other Refractory Anemia Clinical Trials
Other Clinical Trials
Other Lille Clinical Trials
Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome
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