Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
Efficacy and Safety of Two Comparable Single Low Doses of Rasburicase Followed by Allopurinol in Adult Patients With Malignancy
Verified date | December 2017 |
Source | Roswell Park Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized phase II trial studies how well giving rasburicase together with allopurinol works in treating patients with hematologic malignancies. Rasburicase may reduce the level of uric acid in the blood. Allopurinol may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known which dose of rasburicase is more effective in treating hematologic malignancies when given together with or without allopurinol.
Status | Terminated |
Enrollment | 24 |
Est. completion date | May 28, 2016 |
Est. primary completion date | May 28, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) status of 0-3 - Active leukemia and Burkitt leukemia/lymphoma treated in-house that puts them at risk for tumor lysis syndrome (TLS) - Serum uric acid level >= 7.5mg/dL and high risk for TLS as defined by: - A diagnosis of acute myeloid leukemia (AML), or - A diagnosis of blast-phase chronic myeloid leukemia (CML), or - A diagnosis of high-grade myelodysplastic syndrome (MDS) with >= 10% blast bone marrow blast involvement, or - Acute lymphoblastic leukemia (ALL), or - Burkitt leukemia/lymphoma - Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: - History of asthma - History of severe or life threatening atopic allergy - Hypersensitivity to uricases - Known prior sensitivity to allopurinol - Known glucose-6-phosphate dehydrogenase (G6PD) deficiency - Recent prior history of uricolytic therapy defined as therapy within the last 7 days |
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Probability of Obtaining a Uric Acid Level =< 7.5mg/dL | The proportion of patients able to achieve and/or maintain a uric acid level =< 7.5mg/dL for each treatment arm. | Within 24 hours of rasburicase treatment | |
Secondary | Number of Patients Requiring Additional Doses of Rasburicase to Maintain a Uric Acid Level =< 7.5mg/dL | Count of partcicpants requiring additional doses of rasburicase to maintain a uric acid level =< 7.5mg/dL by treatment arm. | Up to day 7 | |
Secondary | Baseline White Blood Cell Count by Response | The mean baseline white blood cell count of patients with a complete response (CR) (patients who achieved uric acid level =< 7.5mg/dL) and no CR (patients with uric acid level > 7.5mg/dL). | Up to day 7 | |
Secondary | Area Under the Plasma Uric Acid Concentration-time Curve (AUC) From Baseline (Day 1) to Day 7 | The mean area under the plasma uric acid concentration-time curve (AUC) from baseline (Day 1) to Day 7 | Up to day 7 | |
Secondary | Safety of Low Single-doses of Rasburicase. | The number of patients with any adverse events . | up to day 7 | |
Secondary | Number of Patients Experiencing a Doubling of Serum Creatinine | Count of participants experiencing a doubling of serum creatinine | up to day 6 |
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