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A Multicenter Registry Study of Anti-rasburicase Antibodies in Patients Retreated With Rasburicase (SR29142) in the Context of Relapsing Leukemia/Lymphoma Who Experienced Subsequent Hypersensitivity Reaction(s) or Loss of Uricolytic Activity: An Immuno-Monitoring Observational Study


N/A
2 Years
N/A
Not Enrolling
Both
Tumor Lysis Syndrome

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Trial Information

A Multicenter Registry Study of Anti-rasburicase Antibodies in Patients Retreated With Rasburicase (SR29142) in the Context of Relapsing Leukemia/Lymphoma Who Experienced Subsequent Hypersensitivity Reaction(s) or Loss of Uricolytic Activity: An Immuno-Monitoring Observational Study

Inclusion Criteria


Inclusion criteria:

1. Previous history of rasburicase exposure and history of administration of a repeat
(2nd) series of rasburicase injections (in the context of supportive care for
relapsing leukemia/lymphoma) and subsequent development of either a hypersensitivity
reaction (HSR) or loss of uricolytic activity (defined as failure to achieve uric
acid level of < or = 7.5 mg/dl measured 48 hours after the first rasburicase
injection).

1. A severe hypersensitivity reaction (NCI Grade 3, 4 or 5) is defined as:

Allergic reaction; allergy; anaphylactic shock; bronchospasm; bullous skin
eruption; dermatitis - exfoliative; drug hypersensitivity; dyspnea; hypotension;
hypoxia; rash; rash - erythematous; rash - maculopapular, urticaria;
pyrexia/fever; edema; chest discomfort; hypersensitivity (NOS); pharynx
discomfort; hoarseness; pharyngeal erythema; pruritus; erythema; localized
exfoliation; rash - papular; swelling ┬┐ face/facial; toxic skin eruption; hot
flush; flushing; rash - macular; rash - pruritic; pruritus - allergic.

2. Loss of uricolytic activity can be defined as:

- uric acid levels > 7.5 mg/dl measured 48 hours after the first rasburicase
injection┬┐, which is a time point coincident with administration of the
third dose of rasburicase (within that second course of treatment with this
agent).

2. Patients should have received at least 2 doses of rasburicase during the repeat (2nd)
administration in the event of loss or uricolytic activity. At least 1 dose of
rasburicase should be administered during the repeat (2nd) administration for
diagnosis of HSR.

Exclusion criteria:

1. Concomitant treatment with human IV immunoglobulin (IVIG)

2. Concomitant treatment with TNF-alpha antagonists/inhibitors, i.e. adalimumab,
infliximab, and etanercept

3. Concomitant treatment with Interferon-alpha (IFN-alpha)

4. Unwillingness or inability to comply with the requirements of the protocol.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Prevalence/frequency of presence of anti-rasburicase antibodies in eligible population.

Outcome Time Frame:

Day 1, i.e. within 48 hours of identification /diagnosis of HSR (hypersensitivity reaction) or loss of uricolytic activity

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Institutional Review Board

Study ID:

RASBU_L_02990

NCT ID:

NCT01097369

Start Date:

February 2010

Completion Date:

February 2010

Related Keywords:

  • Tumor Lysis Syndrome
  • Tumor Lysis Syndrome

Name

Location

Investigational Site Number 3Valhalla, New York  10595
Investigational Site Number 4Oklahoma City, Oklahoma  73104
Investigational Site Number 2Memphis, Tennessee  38105
Investigational Site Number 1Houston, Texas  77030