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Sponsored by: |
Leukemia Research Fund |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005823 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known if stronger doses of chemotherapy given over a longer period of time are as well tolerated or as effective as less intensive chemotherapy.
PURPOSE: This randomized phase III trial is studying intensive regimens of chemotherapy to see how well they work compared to nonintensive regimens of chemotherapy in treating older patients with acute myeloid leukemia or myelodysplastic syndrome.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: cytarabine Drug: daunorubicin hydrochloride Drug: etoposide Drug: hydroxyurea Drug: idarubicin Drug: mitoxantrone hydrochloride Drug: thioguanine Drug: tretinoin Drug: valspodar |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Trial for Patients With Acute Myeloid Leukemia or High Risk Myelodysplatic Syndrome Aged 60 or Over |
Estimated Enrollment: | 2000 |
Study Start Date: | December 1998 |
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Myelodysplastic syndrome
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United Kingdom, England | |
Queen Elizabeth Hospital at University of Birmingham | |
Birmingham, England, United Kingdom, B15 2RR | |
University College Hospital | |
London, England, United Kingdom, WC1E 6AU | |
United Kingdom, Wales | |
University Hospital of Wales | |
Cardiff, Wales, United Kingdom, CF14 4XN |
Study Chair: | Alan K. Burnett, MD, FRCP | The University of New South Wales |
Study ID Numbers: | CDR0000067831, LRF-AML14, EU-20016, ISRCTN62207270 |
Study First Received: | June 2, 2000 |
Last Updated: | July 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00005823 History of Changes |
Health Authority: | United States: Federal Government |
untreated adult acute myeloid leukemia adult acute erythroid leukemia (M6) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloblastic leukemia with maturation (M2) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) adult acute megakaryoblastic leukemia (M7) refractory anemia with excess blasts refractory anemia with excess blasts in transformation chronic myelomonocytic leukemia secondary acute myeloid leukemia |
de novo myelodysplastic syndromes adult acute monocytic leukemia (M5b) secondary myelodysplastic syndromes adult acute minimally differentiated myeloid leukemia (M0) atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) |
Antimetabolites Leukemia, Monocytic, Acute Daunorubicin Chronic Myelomonocytic Leukemia Immunologic Factors Precancerous Conditions Hydroxyurea Acute Myelomonocytic Leukemia Acute Monoblastic Leukemia Leukemia, Myeloid, Acute Etoposide phosphate Refractory Anemia Anti-Bacterial Agents Leukemia Acute Erythroblastic Leukemia |
Preleukemia Acute Myelocytic Leukemia Anemia, Refractory Acute Myeloid Leukemia, Adult Neoplasm Metastasis Analgesics Congenital Abnormalities Etoposide Cytarabine Myelodysplastic Myeloproliferative Disease Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Thioguanine Myelodysplastic Syndromes |
Antimetabolites Anti-Infective Agents Daunorubicin Antimetabolites, Antineoplastic Immunologic Factors Precancerous Conditions Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hydroxyurea Hematologic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Leukemia, Myeloid, Acute Leukemia Preleukemia |
Pathologic Processes Sensory System Agents Therapeutic Uses Syndrome Analgesics Nucleic Acid Synthesis Inhibitors Cytarabine Antisickling Agents Neoplasms by Histologic Type Disease Hematologic Diseases Myelodysplastic Syndromes Thioguanine Myeloproliferative Disorders Enzyme Inhibitors |