CompletedPhase 2

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

United States55 participantsStarted 2011-04

Plain-language 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 safety of this treatment will also be studied.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Number of Participants (Incidence) of LTLS (Laboratory Tumor Lysis Syndrome)

Timeframe: Up to two 3-week cycles, 6 weeks

Number of Cycle 2 Participants Normalizing Uric Acid Levels (UAL) Within 24 Hours of Treatment

Timeframe: Up to 24 hours of cycle 2 dose delivery

Trial details

NCT IDNCT01200485

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-07

Results submitted2017-07-31

View on ClinicalTrials.gov More Leukemia trials