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Sponsored by: |
Swiss Group for Clinical Cancer Research |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00739388 |
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well azacitidine works in treating patients with acute myeloid leukemia who are unsuitable for treatment with intensive chemotherapy.
Condition | Intervention | Phase |
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Leukemia |
Drug: azacitidine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | 5-Azacytidine to Treat Acute Myeloid Leukemia in Elderly or Frail Patients Not Suitable for Intensive Chemotherapy. A Multicenter Phase II Trial. |
Estimated Enrollment: | 43 |
Study Start Date: | July 2008 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive azacitidine subcutaneously on days 1-5. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Must be considered unsuitable for intensive chemotherapy due to ≥ 1 of the following:
PATIENT CHARACTERISTICS:
No serious underlying medical condition in the judgment of the investigator, which could impair the ability of the patient to participate in the trial, including but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Switzerland | |
Centre Hospitalier Universitaire Vaudois | Recruiting |
Lausanne, Switzerland, CH-1011 | |
Contact: Contact Person 41-21-314-4254 | |
Hopitaux Universitaires de Geneve | Recruiting |
Thonex-Geneve, Switzerland, CH-1226 | |
Contact: Contact Person 41-22-372-9870 | |
Inselspital Bern | Recruiting |
Bern, Switzerland, CH-3010 | |
Contact: Contact Person 41-31-632-2111 | |
Universitaetsspital-Basel | Recruiting |
Basel, Switzerland, CH-4031 | |
Contact: Contact Person 41-61-328-6311 | |
Kantonsspital - St. Gallen | Recruiting |
St. Gallen, Switzerland, CH-9007 | |
Contact: Contact Person 41-71-494-1111 | |
UniversitaetsSpital Zuerich | Recruiting |
Zurich, Switzerland, CH-8091 | |
Contact: Contact Person 41-44-255-2214 | |
Kantonspital Aarau | Recruiting |
Aarau, Switzerland, CH-5001 | |
Contact: Contact Person 41-62-838-6053 |
Study Chair: | Jakob Passweg, MD | Hopitaux Universitaires de Geneve |
Investigator: | Sabine Blum, MD | Centre Hospitalier Universitaire Vaudois |
Study ID Numbers: | CDR0000612029, SWS-SAKK-30/07 |
Study First Received: | August 20, 2008 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00739388 History of Changes |
Health Authority: | Unspecified |
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) secondary acute myeloid leukemia untreated adult acute myeloid leukemia 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 monocytic leukemia (M5b) adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) adult acute megakaryoblastic leukemia (M7) |
Antimetabolites Leukemia, Monocytic, Acute Acute Myelomonocytic Leukemia Leukemia, Myeloid Acute Monoblastic Leukemia Leukemia, Myeloid, Acute Leukemia, Myelomonocytic, Acute Leukemia |
Acute Myelocytic Leukemia Acute Erythroblastic Leukemia Leukemia, Erythroblastic, Acute Acute Myeloid Leukemia, Adult Azacitidine Neoplasm Metastasis Congenital Abnormalities Di Guglielmo's Syndrome |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Leukemia, Myeloid |
Leukemia, Myeloid, Acute Pharmacologic Actions Leukemia Neoplasms Therapeutic Uses Azacitidine |