NCT00360438

Brief Summary

Primary 1\. To determine the pharmacokinetic (PK) parameters of rasburicase in adult patients with leukemia and/or lymphoma at high risk or potential risk of tumor lysis syndrome (TLS) Secondary

  1. 1.To evaluate plasma uric acid AUC from baseline (within 4 hours prior to first rasburicase treatment) through 48 hours after the last per-protocol planned administration of rasburicase treatment;
  2. 2.To evaluate the safety of rasburicase in adult patients with leukemia and/or lymphoma.
  3. 3.To evaluate incidence, duration, and type of immune responses (IgG, IgE, and neutralizing antibody) to rasburicase.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1 leukemia

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_1 leukemia

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

July 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

9 months

First QC Date

August 2, 2006

Last Update Submit

July 31, 2012

Conditions

LeukemiaLymphomaTumor Lysis Syndrome

Keywords

LeukemiaLymphomaTumor Lysis SyndromeTLSRasburicaseElitek

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of rasburicase in treatment of patients with leukemia and/or lymphoma who are at high or potential risk for TLS.

    4 Years

Study Arms (1)

Rasburicase

EXPERIMENTAL
Drug: Rasburicase

Interventions

RasburicaseDRUG

0.15mg/kg intravenously over 30 minutes once per day for 5 consecutive days.

Also known as: Elitek
Rasburicase

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>/= 18
  • Risk of TLS: A. High risk: hyperuricemia of malignancy; diagnosis of aggressive lymphoma/leukemia based on Revised European-American Lymphoma (REAL) classification; acute myeloid leukemia in blast crisis; high grade myelodysplastic syndrome only if they have \>10% bone marrow blast involvement and given aggressive treatment similar to AML; OR B. Potential risk: diagnosis of aggressive lymphoma/leukemia based on (REAL) classification. Plus one or more of the following criteria: LDH \>/=2 x 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
  • Positive tests for HBs antigen, HCV antibodies, or HIV-1, 2 antibodies
  • Hypersensitivity to uricases or any of the excipients
  • Previous therapy with urate oxidase
  • Other conditions unsuitable for participation in the trial in the Investigator's opinion
  • Unwilling to comply with the requirements of the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaLymphomaTumor Lysis Syndrome

Interventions

rasburicase

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Saroj Vadhan-Raj, M.D.

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2006

First Posted

August 4, 2006

Study Start

July 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

US(1)