Elitek (Rasburicase) Immuno-Monitoring Study

NCT01097369 | Terminated

• 1 other identifier: RASBU_L_02990
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 4

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.

Conditions

Tumor Lysis Syndrome

Outcome Measures

Primary Outcomes (2)

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

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

• Titer/type of anti-rasburicase antibodies in eligible population.

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

Study Arms (1)

Anti-rasburicase antibodies

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).
• 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.
• 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).
• 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.

You may not qualify if:

• Concomitant treatment with human IV immunoglobulin (IVIG)
• Concomitant treatment with TNF-alpha antagonists/inhibitors, i.e. adalimumab, infliximab, and etanercept
• Concomitant treatment with Interferon-alpha (IFN-alpha)
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (4)

Investigational Site Number 3

Valhalla, New York, 10595, United States

Location

Investigational Site Number 4

Oklahoma City, Oklahoma, 73104, United States

Location

Investigational Site Number 2

Memphis, Tennessee, 38105, United States

Location

Investigational Site Number 1

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Tumor Lysis Syndrome

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: April 1, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: January 31, 2013

Record last verified: 2013-01

Locations

US (4)