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Sponsored by: |
Jonsson Comprehensive Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00112983 |
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eculizumab may prevent leukemia and stop the destruction of red blood cells in patients with paroxysmal nocturnal hemoglobinuria.
PURPOSE: This randomized phase III trial is studying how well eculizumab works in treating patients with paroxysmal nocturnal hemoglobinuria.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: eculizumab |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | TRIUMPH: A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients |
Study Start Date: | November 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to the number of packed red blood cell (PRBC) units transfused 1 year prior to screening (< 15 units vs 15-25 units vs > 25 units). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline; at weeks 0-4, 12, 20, and 26 during study treatment; then at weeks 1, 2, 4, and 8 after completion of study treatment.
After completion of study treatment, patients are followed at weeks 1, 2, 4, and 8.
PROJECTED ACCRUAL: Approximately 75 patients (37 per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have required ≥ 4 episodes of transfusions for anemia or anemia-related symptoms within the past year
Must have received 1 packed red blood cell transfusion during the study observation period (within 48 hours of the hemoglobin level that precipitated the transfusion) and within 1.5 g/dL of the mean pre-transfusion hemoglobin level over the past year
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
NOTE: **Provided dose is stable for the past 4 weeks and expected to remain stable (or decrease for corticosteroids) during study observation and treatment
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1678 |
Principal Investigator: | Ronald Paquette, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000409569, UCLA-0406101-01, ALEXION-C04-001 |
Study First Received: | June 2, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00112983 |
Health Authority: | United States: Federal Government |
adult acute lymphoblastic leukemia adult acute myeloid leukemia |
Paroxysmal nocturnal hemoglobinuria Leukemia, Lymphoid Leukemia, Myeloid, Acute Acute lymphoblastic leukemia, adult Signs and Symptoms Leukemia Preleukemia Urologic Diseases Hemoglobinuria, Paroxysmal Acute myeloid leukemia, adult Acute myelocytic leukemia Myelodysplastic syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma |
Urination Disorders Hematologic Diseases Myelodysplastic Syndromes Myelodysplasia Anemia Acute myelogenous leukemia Anemia, Hemolytic Leukemia, Myeloid Hemoglobinuria Proteinuria Marchiafava-Micheli disease Bone Marrow Diseases |
Urological Manifestations Neoplasms Neoplasms by Histologic Type |