Rasburicase in Patients at High Risk for Tumor Lysis Syndrome (TLS) During Cycle-2
This study is currently recruiting participants.
Verified March 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Sanofi
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01200485
First received: September 9, 2010
Last updated: March 14, 2013
Last verified: March 2013
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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.
| Estimated Enrollment: | 55 |
| Study Start Date: | April 2011 |
| Estimated Primary Completion Date: | April 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rasburicase Alone
Cycle 1 - All receive 0.15 mg/kg IV Day 1.
|
Drug: Rasburicase
0.15 mg/kg by vein over 30 minutes on day 1 of 21 day cycle, additional dose Days 2-5 at physician discretion.
|
|
Experimental: Arm A (Rasburicase)
Randomized Cycle 2, Rasburicase 0.15 mg/kg IV Day 1.
|
Drug: Rasburicase
0.15 mg/kg by vein over 30 minutes on day 1 of 21 day cycle, additional dose Days 2-5 at physician discretion.
|
|
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
300 mg/day by vein over 30 minutes each day on days 1-5 of cycle 2 in 21 day cycle.
Other Names:
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Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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-CVAD alternating with MTX/ARA-C) will be eligible.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200485
Contacts
| Contact: Saroj Vadhan-Raj, MD | 713-792-7966 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Sanofi
Investigators
| Principal Investigator: | Saroj Vadhan-Raj, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01200485 History of Changes |
| Other Study ID Numbers: | 2010-0284 |
| Study First Received: | September 9, 2010 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
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:
|
Leukemia Lymphoma Tumor Lysis Syndrome Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Allopurinol Rasburicase |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Gout Suppressants Antirheumatic Agents Therapeutic Uses Free Radical Scavengers Antioxidants Antimetabolites Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013