Overview

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

Status:
Completed

Trial end date:
2016-07-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborator:

Sanofi

Treatments:

Allopurinol
Rasburicase

Criteria

Inclusion Criteria:

1. 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.

2. Eastern Cooperative Oncology Group (ECOG) performance status 0-3.

3. Negative pregnancy test (females of child bearing potential) within rasburicase dose and use of efficient contraceptive method (both males and females).
Pregnancy test may be performed on serum (HCG) or urine (HCG).

4. Signed written informed consent approved by the Institutional Review Board obtained
prior to study entry.

Exclusion Criteria:

1. Prior H/O severe allergy or asthma requiring active treatment.

2. Patients with mantle cell lymphoma (MCL) with stage 1 or 2 disease.

3. Patient receiving any investigational drug for hyperuricemia within 30 days of planned
first treatment with rasburicase.

4. Pregnancy or lactation.

5. Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.

6. Known history of hemolysis and/or methemoglobinemia.

7. Previous therapy with urate oxidase.

8. Conditions unsuitable for participation in the trial in the Investigator's opinion.

9. Unwillingness to comply with the requirements of the protocol.

10. Use of allopurinol within 72 hours of the study entry.