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

Leukemia research study

What is the primary objective of this study?

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 is eligible to participate?

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 </= 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). 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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Leukemia

Lymphoma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:RasburicaseCycle 1: All receive 3 mg/kg by vein on Day 1, plus as needed dosing (until day 5), during Cycle 1. Cycle 2 Arm A: 0.15 mg/kg by vein on Day 1 of Cycle 2, plus as needed dosing (until day 5), during Cycle 2.

Drug:AllopurinolArm B: 300 mg/day by vein over 30 minutes each day on days 1-5 of cycle 2 in 21 day cycle.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Rasburicase AloneCycle 1 - All receive 3 mg/kg IV Day 1.

Arm A (Rasburicase)Randomized Cycle 2, Rasburicase 0.15 mg/kg IV Day 1.

Arm B (Allopurinol)Randomized Cycle 2, Allopurinol 300 mg/day IV Days 1-5 + Rasburicase 0.15 mg/kg IV Day 1 if uric acid blood levels dictate single dose or more.

Study Status

Completed

Start Date: April 2011

Completed Date: July 2016

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Incidence of Laboratory Tumor Lysis Syndrome (LTLS) during cycle-2

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Saroj Vadhan-Raj, MD

Lead Sponsor: M.D. Anderson Cancer Center

Collaborator: Sanofi

More information:https://clinicaltrials.gov/show/NCT01200485

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