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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00077116 |
RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells. Giving healthy stem cells from a donor whose blood closely resembles the patient's blood will help the patient's bone marrow make new stem cells that become red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine together with gemtuzumab ozogamicin works in treating patients with previously untreated high-risk myelodysplastic syndrome or acute myeloid leukemia secondary to myelodysplastic syndrome.
Condition | Intervention | Phase |
---|---|---|
Leukemia Myelodysplastic Syndromes |
Drug: busulfan Drug: cyclophosphamide Drug: cytarabine Drug: gemtuzumab ozogamicin Drug: idarubicin Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | 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 |
Estimated Enrollment: | 28 |
Study Start Date: | November 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups.
Group 2 (for patients with an HLA-matched sibling donor): Patients are randomized to 1 of 2 treatment arms.
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.
Ages Eligible for Study: | 16 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
High-risk myelodysplastic syndromes (MDS), including any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Belgium | |
AZ Sint-Jan | |
Brugge, Belgium, 8000 | |
Cliniques Universitaires Saint-Luc | |
Brussels, Belgium, 1200 | |
H. Hartziekenhuis - Roeselaere. | |
Roeselare, Belgium, 8800 | |
Institut Jules Bordet | |
Brussels, Belgium, 1000 | |
Germany | |
Ruprecht - Karls - Universitaet Heidelberg | |
Heidelberg, Germany, D-69117 | |
Netherlands | |
Leiden University Medical Center | |
Leiden, Netherlands, 2300 CA | |
Onze Lieve Vrouwe Gasthuis | |
Amsterdam, Netherlands, 1091 HA | |
Universitair Medisch Centrum St. Radboud - Nijmegen | |
Nijmegen, Netherlands, NL-6500 HB | |
Switzerland | |
Universitaetsspital-Basel | |
Basel, Switzerland, CH-4031 |
Investigator: | Theo De Witte, MD, PhD | Universitair Medisch Centrum St. Radboud - Nijmegen |
Study ID Numbers: | CDR0000349501, EORTC-06013 |
Study First Received: | February 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00077116 |
Health Authority: | United States: Federal Government |
untreated adult acute myeloid leukemia refractory anemia with excess blasts refractory anemia with excess blasts in transformation chronic myelomonocytic leukemia de novo myelodysplastic syndromes secondary myelodysplastic syndromes |
adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with t(15;17)(q22;q12) childhood myelodysplastic syndromes |
Precancerous Conditions Refractory anemia Chronic myelomonocytic leukemia Cyclophosphamide Leukemia, Myeloid, Acute Antibodies, Monoclonal Leukemia Preleukemia Anemia, Refractory Neoplasm Metastasis Acute myeloid leukemia, adult Congenital Abnormalities Acute myelocytic leukemia Cytarabine Immunoglobulins |
Myelodysplastic syndromes Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Myelodysplasia Anemia Acute myelogenous leukemia Leukemia, Myeloid Gemtuzumab Antibodies Idarubicin Busulfan Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Antiviral Agents |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Pathologic Processes Syndrome Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |