Phase 2
Completed N=55
Rasburicase in Patients at High Risk for Tumor Lysis Syndrome (TLS) During Cycle-2
Source: ClinicalTrials.gov NCT01200485 ↗Enrolled (actual)
55
Serious AEs
5.1%
Results posted
Jan 2020
Primary outcomePrimary: Number of Participants (Incidence) of LTLS (Laboratory Tumor Lysis Syndrome) — 1; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants (Incidence) of LTLS (Laboratory Tumor Lysis Syndrome) |
1; 1 | — |
| PRIMARY Number of Cycle 2 Participants Normalizing Uric Acid Levels (UAL) Within 24 Hours of Treatment |
20; 25 | — |
Eligibility Criteria
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.
- Unwillingness to comply with the requirements of the protocol.
- Use of allopurinol within 72 hours of the study entry.
Data sourced from ClinicalTrials.gov (NCT01200485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.