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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Sanofi-Aventis |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00360438 |
Primary
1. To determine the pharmacokinetic (PK) parameters of rasburicase in adult patients with leukemia and/or lymphoma at high risk or potential risk of tumor lysis syndrome (TLS)
Secondary
Condition | Intervention | Phase |
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Leukemia Lymphoma Tumor Lysis Syndrome |
Drug: Rasburicase |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Pharmacokinetic Evaluation of Rasburicase Dosed for 5 Consecutive Days as Uricolytic Therapy in Adult Patients With Leukemia and/or Lymphoma at High or Potential Risk of Tumor Lysis Syndrome (TLS) |
Estimated Enrollment: | 20 |
Study Start Date: | July 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
The University of Texas M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Saroj Vadhan-Raj, M.D. | M.D. Anderson Cancer Center |
Study ID Numbers: | 2006-0298 |
Study First Received: | August 2, 2006 |
Last Updated: | May 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00360438 |
Health Authority: | United States: Food and Drug Administration |
Leukemia Lymphoma Tumor Lysis Syndrome TLS Rasburicase |
Lymphatic Diseases Leukemia Immunoproliferative Disorders Tumor Lysis Syndrome |
Lymphoproliferative Disorders Rasburicase Lymphoma |
Neoplasms Pathologic Processes Disease Neoplasms by Histologic Type Immune System Diseases |
Therapeutic Uses Syndrome Antirheumatic Agents Gout Suppressants Pharmacologic Actions |