Idarubicin and Ara-C in Combination With Gemtuzumab-Ozogamicin (IAGO) for Young Untreated Patients, Without an HLA Identical Sibling, With High Risk MDS or AML Developing After a Preceding Period With MDS During 6 Months Duration: A Phase II Study
Data Collection
Bone Marrow Diseases+8
+ Disease
+ Hematologic Diseases
Treatment Study
Summary
Study start date: November 1, 2003
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Determine the feasibility of combining gemtuzumab ozogamicin with idarubicin and cytarabine with or without cyclophosphamide with total body irradiation vs busulfan followed by allogeneic stem cell transplantation in patients with previously untreated high-risk myelodysplastic syndromes (MDS) or acute myeloid leukemia secondary to MDS. * Determine the toxicity profile of this regimen in these patients. * Determine the antileukemic/anti-MDS activity of this regimen in these patients. Secondary * Determine the hepatotoxicity of this regimen, in terms of veno-occlusive disease, in these patients. * Determine the severity of pancytopenia and duration of recovery in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups. * Group 1 (for patients with no HLA-matched sibling donor): Patients receive remission-induction chemotherapy comprising idarubicin IV over 5 minutes on days 1, 3, and 5; cytarabine IV continuously over 24 hours on days 1-10; and gemtuzumab ozogamicin IV over 2 hours on day 7. Treatment continues for a second course in the absence of unacceptable toxicity. * Group 2 (for patients with an HLA-matched sibling donor): Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive myeloablative consolidation chemotherapy comprising cyclophosphamide on days -6 and -5 and total body irradiation twice daily on days -4 to -2. * Arm II: Patients receive myeloablative consolidation chemotherapy comprising busulfan on days -8 to -5 and cyclophosphamide on days -4 and -3. Patients in both arms may alternatively undergo T-cell depletion and/or a reduced-intensity conditioning regimen. Approximately 4-8 weeks after completion of consolidation chemotherapy, all patients in group 2 undergo allogeneic bone marrow transplantation or allogeneic peripheral blood stem cell transplantation. Patients in group 2 then proceed to remission-induction chemotherapy as in group 1. Patients achieving complete remission are recommended for consolidation therapy off study. Patients are followed monthly for 6 months, every 2 months for 6 months, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study within 10 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.31 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 16 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following: * High-risk myelodysplastic syndromes (MDS), including any of the following: * Refractory anemia with excess blasts (RAEB) with \> 10% blast cells in the bone marrow * RAEB in transformation * Other forms of MDS with multiple (3 or more) chromosomal abnormalities or chromosome 7 abnormalities AND/OR profound cytopenias, defined as neutrophil count \< 500/mm\^3 and/or platelet count \< 20,000/mm\^3 * Chronic myelomonocytic leukemia with \> 5% blast cells in the bone marrow * Chronic myelomonocytic leukemia with neutrophil count \> 16,000/mm\^3 OR monocyte count \> 2,600/mm\^3 * Secondary acute myeloid leukemia supervening after overt MDS of more than 6 months in duration * Patients with or without an HLA-identical sibling * No active CNS leukemia PATIENT CHARACTERISTICS: Age * 16 to 70 Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No severe cardiovascular disease * No arrhythmias requiring chronic treatment * No congestive heart failure * No symptomatic ischemic heart disease Pulmonary * No severe lung disease Other * Not pregnant or nursing * Fertile patients must use effective contraception * No HIV positivity * No other concurrent malignant disease * No active uncontrolled infection * No history of alcohol abuse (i.e., averaged less than 5 alcoholic consumptions daily for the past year) * No concurrent severe neurological or psychiatric disease * No other psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * More than 6 weeks since prior growth factors Chemotherapy * No prior intensive chemotherapy * More than 6 weeks since prior low-dose chemotherapy or hydroxyurea Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 6 weeks since prior immunosuppressants * No prior participation in this clinical study
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 9 locations
Institut Jules Bordet
Brussels, BelgiumCliniques Universitaires Saint-Luc
Brussels, BelgiumH. Hartziekenhuis - Roeselaere.
Roeselare, Belgium