Rasburicase in Patients at High Risk for Tumor Lysis Syndrome (TLS) During Cycle-2

Completed · Phase 2

Conditions studied: Leukemia, Lymphoma

In brief

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 safety of this treatment will also be studied.

Key facts

Study ID

NCT01200485

Run by

M.D. Anderson Cancer Center

People needed

55

Starts

2011-04-01

Expected to finish

2016-07-01

Last updated by the study team

2020-01-31

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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