Status:
COMPLETED
Rasburicase in Patients at High Risk for Tumor Lysis Syndrome (TLS) During Cycle-2
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Sanofi
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if using Elitek (rasburicase) for 2 cycles can help to control or prevent TLS better than 1 cycle of rasburicase and 1 cycle of allopurinol. The sa...
Detailed Description
Study Drugs: Rasburicase is designed to help decrease or prevent the high level of uric acid that may occur during the beginning of chemotherapy. A high level of uric acid results from TLS and can le...
Eligibility Criteria
Inclusion
- Patients that are high risk for TLS or potential/intermediate risk for TLS as described below: (a) High risk: Hyperuricemia of malignancy (Uric acid levels \>7.5); or diagnosis of very aggressive lymphoma/leukemia based on Revised European-American Lymphoma (REAL) classification; acute myeloid leukemia, CML in blast crisis; high grade myelodysplastic syndrome only if they have \>10% bone marrow blast involvement and given aggressive treatment similar to acute myeloid leukemia (AML). (b) Potential risk: Diagnosis of aggressive lymphoma/leukemia based on (REAL) classification. Plus one or more of the following criteria: lactate dehydrogenase (LDH) \>/= 2 x upper limit of normal (UNL); Stage III-IV disease; Stage I-II disease with at least 1 lymph node/tumor \> 5 cm in diameter. For patients with potential/intermediate risk for TLS- Only those planned to receive alternating regimens (or non-standard regimens) in 2 cycles (example; R-Hyper-central venous access device (CVAD) alternating with MTX/ARA-C) will be eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3.
- Negative pregnancy test (females of child bearing potential) within \</= 1 week of rasburicase dose and use of efficient contraceptive method (both males and females). Pregnancy test may be performed on serum (HCG) or urine (HCG).
- Signed written informed consent approved by the Institutional Review Board obtained prior to study entry.
Exclusion
- Prior H/O severe allergy or asthma requiring active treatment.
- Patients with mantle cell lymphoma (MCL) with stage 1 or 2 disease.
- Patient receiving any investigational drug for hyperuricemia within 30 days of planned first treatment with rasburicase.
- Pregnancy or lactation.
- Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Known history of hemolysis and/or methemoglobinemia.
- Previous therapy with urate oxidase.
- Conditions unsuitable for participation in the trial in the Investigator's opinion.
- Unwillingness to comply with the requirements of the protocol.
- Use of allopurinol within 72 hours of the study entry.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01200485
Start Date
April 1 2011
End Date
July 1 2016
Last Update
January 31 2020
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030