NCT00628628

Brief Summary

Primary Objectives: To determine the efficacy of rasburicase administered as a single dose followed by as needed dosing (investigational arm) as compared to fixed dosing for 5 days (standard treatment arm) in the treatment of patients at high risk or potential risk for tumor lysis syndrome. Secondary Objectives:

  1. 1.To evaluate the plasma uric acid area under the curve (AUC) from baseline through 7 days
  2. 2.To evaluate the incidence of renal insufficiency and electrolyte abnormalities.
  3. 3.To determine the safety and immunogenicity of rasburicase.
  4. 4.To evaluate the cost-effectiveness of the experimental treatment (investigational arm).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

August 1, 2013

Completed
Last Updated

August 1, 2013

Status Verified

May 1, 2013

Enrollment Period

4.3 years

First QC Date

February 25, 2008

Results QC Date

May 31, 2013

Last Update Submit

May 31, 2013

Conditions

Tumor Lysis Syndrome

Keywords

Tumor Lysis SyndromeTLShyperuricemiaLeukemiaLymphomaAcute myeloid leukemiaChronic myelocytic leukemiaCMLlactate dehydrogenaseLDHMyelodysplastic SyndromeRasburicaseElitek™

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Plasma Uric Acid (UA) Response

    Plasma UA response is defined as normalization of plasma UA levels within 48 hours after the start of study drug (rasburicase) and maintaining within the normal range after the final drug infusion on day 5. Plasma samples for UA were collected at baseline before rasburicase, 4- and 24-hours post-rasburicase, and daily during treatment.

    First cycle of chemotherapy, up to 5 days

Study Arms (2)

Group A

EXPERIMENTAL

As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.

Drug: As Needed Rasburicase

Group B

EXPERIMENTAL

Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily

Drug: Fixed Dose Rasburicase

Interventions

As Needed RasburicaseDRUG

.15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.

Also known as: Elitek™
Group A
Fixed Dose RasburicaseDRUG

.15 mg/kg IV Over 30 Minutes Daily

Also known as: Elitek™
Group B

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with hematological malignancies (leukemia/lymphoma) at high risk or potential risk for tumor lysis syndrome. High risk: hyperuricemia of malignancy (Uric acid levels \>7.5); diagnosis of very aggressive lymphoma/leukemia based on Revised European-American Lymphoma (REAL) classification; acute myeloid leukemia, chronic myelocytic 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) (continued on #2)
  • (continued from # 1) 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 (ULN); Stage III-IV disease; Stage I-II disease with at least 1 lymph node/tumor \>5cm in diameter.
  • ECOG performance status 0-3
  • Life expectancy \>3 months
  • Negative pregnancy test (females of child bearing potential) within \</=2 weeks 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/Ethics Committee) obtained prior to study entry

You may not qualify if:

  • Patient receiving any investigational drug for hyperuricemia within 30 days of planned first treatment with rasburicase
  • Pregnancy or lactation
  • Known history of significant allergy problem or documented history of asthma or asthmatic bronchitis
  • Known history of glucose-6-phosphate dehydrogenase deficiency
  • Known history of hemolysis and methemoglobinemia
  • Previous therapy with urate oxidase
  • Other 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Vadhan-Raj S, Fayad LE, Fanale MA, Pro B, Rodriguez A, Hagemeister FB, Bueso-Ramos CE, Zhou X, McLaughlin PW, Fowler N, Shah J, Orlowski RZ, Samaniego F, Wang M, Cortes JE, Younes A, Kwak LW, Sarlis NJ, Romaguera JE. A randomized trial of a single-dose rasburicase versus five-daily doses in patients at risk for tumor lysis syndrome. Ann Oncol. 2012 Jun;23(6):1640-5. doi: 10.1093/annonc/mdr490. Epub 2011 Oct 19.

    PMID: 22015451RESULT

Related Links

MeSH Terms

Conditions

Tumor Lysis SyndromeHyperuricemiaLeukemiaLymphomaLeukemia, Myeloid, AcuteLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyelodysplastic Syndromes

Interventions

rasburicase

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease Attributes

Results Point of Contact

Title
Saroj Vadhan-Raj, MD / Professor
Organization
The University of Texas (UT) MD Anderson Cancer Center
CR_Study_Registration@mdanderson.org

Study Officials

  • Saroj Vadhan-Raj, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 5, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

August 1, 2013

Results First Posted

August 1, 2013

Record last verified: 2013-05

Locations

US(1)