Elitek (Rasburicase) Immuno-Monitoring Study

Sanofi

Status: Terminated

Conditions: Tumor Lysis Syndrome

Study type: Observational

Funder types: Industry

Identifiers

NCT01097369

RASBU_L_02990

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1 participants in 1 patient group

Anti-rasburicase antibodies