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Home > "C" Clinical Trials Conditions > Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia  Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia
Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia
For Condition: adult acute monocytic leukemia,secondary acute myeloid leukemia,adult acute myeloid leukemia
Status: Recruiting
Sponsor(s): EORTC Leukemia Cooperative Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combining combination chemotherapy with monoclonal antibody therapy will kill more cancer cells. PURPOSE: Randomizedphase III trial to determine the effectiveness of combination chemotherapy with or without gemtuzumab ozogamicin in treating patients who have acute myeloid leukemia.
Details: OBJECTIVES: - Determine the antileukemic activity of standard induction chemotherapy with or without gemtuzumab ozogamicin in elderly patients with previously untreated acute myeloid leukemia. - Determine the overall survival of patients treated with these regimens. - Determine the rate of response, disease-free survival, event-free survival, incidence of relapse, and incidence of death of patients treated with these regimens. - Determine the rate, type, and grade of toxicity of these regimens in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to age (61-69 vs 70-75), CD33 positivity (less than 5% vs 5-19% vs 20-80% vs more than 80% vs unknown), initial WBC before hydroxyurea administration if needed (less than 30,000/mm^3 vs at least 30,000/mm^3), and participating center. Patients are randomized to 1 of 2 treatment arms. - Induction (phase I): Patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15. - Induction (phase II/MICE regimen): Beginning between days 50 and 53, patients receive mitoxantrone IV over 30 minutes on days 1, 3, and 5; etoposide IV over 1 hour on days 1-3; and cytarabine IV continuously on days 1-7. Bone marrow evaluation is performed on day 29. Patients with partial remission (PR) receive a second course of MICE chemotherapy regimen. Patients with complete remission (CR) after 1 or 2 courses of MICE regimen proceed to consolidation therapy. Patients with progressive disease go off therapy. - Consolidation: Beginning within 4 weeks of documentation of CR, patients receive gemtuzumab ozogamicin IV over 2 hours on day 0; idarubicin IV on days 1, 3, and 5; etoposide IV over 1 hour on days 1-3; and cytarabine IV continuously on days 1-5. After at least day 30, patients receive a second consolidation course in the absence of disease progression or unacceptable toxicity. - Induction (MICE regimen): Patients receive mitoxantrone, etoposide, and cytarabine as in arm I induction. Bone marrow evaluation is performed on day 29. Patients with PR receive a second course of MICE chemotherapy regimen. Patients with CR after 1 or 2 courses of MICE regimen proceed to consolidation therapy. Patients with progressive disease go off therapy. - Consolidation: Patients receive idarubicin, etoposide, and cytarabine as in arm I consolidation. Patients are followed monthly for 1 year, every 3 months for 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 450 patients (225 per treatment arm) will be accrued for this study within 3.75 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 61 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of acute myeloid leukemia (AML) - Bone marrow blasts at least 20% by bone marrow aspiration or biopsy - FAB subtypes M0-M2 and M4-M7 - No acute promyelocytic leukemia (FAB subtype M3) - Previously untreated primary or secondary AML, including AML after myelodysplastic syndromes - Hydroxyurea and/or corticosteroid therapy for no more than 14 days allowed - No blast crisis of chronic myelogenous leukemia - No AML supervening after other myeloproliferative diseases - No active CNS leukemia PATIENT CHARACTERISTICS: Age - 61 to 75 Performance status - WHO 0-2 Life expectancy - Not specified Hematopoietic - WBC less than 30,000/mm^3 (pretreatment with hydroxyurea for no more than 14 days allowed) Hepatic - Bilirubin no greater than 3 times upper limit of normal (ULN) Renal - Creatinine no greater than 3 times ULN Cardiovascular - No concurrent severe cardiovascular disease - No arrhythmias requiring chronic treatment - No congestive heart failure - No symptomatic ischemic heart disease Pulmonary - No severe pulmonary dysfunction (CTC grade 3-4) Other - HIV negative - No other uncontrolled infection - No other concurrent malignant disease - No severe concurrent neurological or psychiatric disease - No prior alcohol abuse - No psychological, familial, sociological, or geographical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent hematopoietic growth factors (filgrastim [G-CSF] or sargramostim [GM-CSF]) except for life-threatening infection due to neutropenia Chemotherapy - See Disease Characteristics Endocrine therapy - See Disease Characteristics Radiotherapy - Not specified Surgery - Not specified Other - No prior enrollment in this trial
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SergioAmadori, , Ospedale Sant' Eugenio
CHU Liege - Domaine Universitaire du Sart Tilman *Recruiting*
LIEGE, , B-4000
Belgium
Recruiting Contact Person 32-366-7111
Hopital de Jolimont *Recruiting*
Haine-Saint-Paul, , 7100
Belgium
Recruiting Contact Person 32-23-3011
A.Z. St. Jan *Recruiting*
Brugge, , 8000
Belgium
Recruiting Contact Person 32-452-800
Ospedale Sant' Eugenio *Recruiting*
Rome, , 00144
Italy
Recruiting Contact Person 39-06-5914745
Institut Jules Bordet *Recruiting*
Brussels, , 1000
Belgium
Recruiting Contact Person 32-541-3111
Hopital Universitaire Erasme *Recruiting*
Brussels, , 1070
Belgium
Recruiting Contact Person 32-555-3111
Centre Hospitalier Peltzer-La Tourelle *Recruiting*
Verviers, , B-4800
Belgium
Recruiting Contact Person 32-212-111
Leiden University Medical Center *Recruiting*
Leiden, , 2300 CA
Netherlands
Recruiting Contact Person 31-52-6911
Onze Lieve Vrouwe Gasthuis *Recruiting*
Amsterdam, , 1091 HA
Netherlands
Recruiting Contact Person 31-599-9111
Hospital Escolar San Joao *Recruiting*
Porto, , 4200
Portugal
Recruiting Contact Person 22-551-2100
Ruprecht - Karls - Universitaet Heidelberg *Recruiting*
Heidelberg, , D-69117
Germany
Recruiting Contact Person 49-568-011
Additional Information:
Study ID Numbers: CDR0000258151; AML-17,EORTC-06012
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052299
Other Adult Acute Monocytic Leukemia Studies:
1. Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia
2. Combination Chemotherapy With or Without Monoclonal Antibody Therapy Followed by Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia
3. Combination Chemotherapy With or Without Filgrastim and/or Tretinoin in Treating Patients With Acute Myeloid Leukemia
4. Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
5. Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
Related Studies:
Other adult acute monocytic leukemia Clinical Trials
Other Clinical Trials
Other Brussels Clinical Trials
Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia
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