Clinical trial NCT01097369: Elitek (Rasburicase) Immuno-Monitoring Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Tumor Lysis Syndrome
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-04-01
Enrollment: 1
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are selected as the clinical manifestations for study inclusion (hypersensitivity reaction or the loss of uricolytic activity) are recognized during clinically-indicated re-challenge with rasburicase.

Brief summary: Primary Objective:

To determine the incidence, titer and type of anti-rasburicase antibodies in the context of hypersensitivity reaction(s) or the loss of uricolytic activity occurring in patients with relapsed leukemia/lymphoma who have been re-treated with rasburicase and have experienced a hypersensitivity reaction or loss of uricolytic activity.


Eligibility 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.

Primary outcomes:
measure: Prevalence/frequency of presence of anti-rasburicase antibodies in eligible population.
timeFrame: Day 1, i.e. within 48 hours of identification /diagnosis of HSR (hypersensitivity reaction) or loss of uricolytic activity
measure: Titer/type of anti-rasburicase antibodies in eligible population.
timeFrame: Day 1, i.e. within 48 hours of identification /diagnosis of HSR (hypersensitivity reaction) or loss of uricolytic activity
Secondary outcomes:
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: Investigational Site Number 3
state: New York
city: Oklahoma City
country: United States
facility: Investigational Site Number 4
state: Oklahoma
city: Memphis
country: United States
facility: Investigational Site Number 2
state: Tennessee
city: Houston
country: United States
facility: Investigational Site Number 1
state: Texas
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: