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