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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01200485
First received: September 9, 2010
Last updated: July 14, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Leukemia
Lymphoma
Drug: Rasburicase
Drug: Allopurinol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Study to Evaluate the Efficacy of Rasburicase in Patients at Risk for TLS During Two Cycles of Chemotherapy

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Incidence of Laboratory Tumor Lysis Syndrome (LTLS) during cycle-2 [ Time Frame: Two 3-week cycles ] [ Designated as safety issue: No ]
    Number of patients (incidence) of LTLS in the two arms, as defined by the Cairo-Bishop criteria, during cycle 2.


Enrollment: 55
Study Start Date: April 2011
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rasburicase Alone
Cycle 1 - All receive 3 mg/kg IV Day 1.
Drug: Rasburicase

Cycle 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.

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

Cycle 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.

Experimental: 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.
Drug: Allopurinol
Arm B: 300 mg/day by vein over 30 minutes each day on days 1-5 of cycle 2 in 21 day cycle.
Other Names:
  • Loprin
  • Zurinol
  • Zyloprim

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 </= 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200485

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Sanofi
Investigators
Principal Investigator: Saroj Vadhan-Raj, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01200485     History of Changes
Other Study ID Numbers: 2010-0284  NCI-2012-01889 
Study First Received: September 9, 2010
Last Updated: July 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Supportive Care
Recombinant urate oxidase
Chemotherapy
Tumor Lysis Syndrome (TLS)
Hematologic malignancies
Acute myeloid leukemia

Additional relevant MeSH terms:
Tumor Lysis Syndrome
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Allopurinol
Rasburicase
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 07, 2016