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Elitek (Rasburicase) Immuno-Monitoring Study

This study has been terminated.
(business decision due to low subject recruitment)
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01097369
First received: March 31, 2010
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Tumor Lysis Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Drug Information available for: Rasburicase
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Prevalence/frequency of presence of anti-rasburicase antibodies in eligible population. [ Time Frame: Day 1, i.e. within 48 hours of identification /diagnosis of HSR (hypersensitivity reaction) or loss of uricolytic activity ] [ Designated as safety issue: No ]
  • Titer/type of anti-rasburicase antibodies in eligible population. [ Time Frame: Day 1, i.e. within 48 hours of identification /diagnosis of HSR (hypersensitivity reaction) or loss of uricolytic activity ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: February 2010
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Anti-rasburicase antibodies

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097369

Locations
United States, New York
Investigational Site Number 3
Valhalla, New York, United States, 10595
United States, Oklahoma
Investigational Site Number 4
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Investigational Site Number 2
Memphis, Tennessee, United States, 38105
United States, Texas
Investigational Site Number 1
Houston, Texas, United States, 77030
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01097369     History of Changes
Other Study ID Numbers: RASBU_L_02990
Study First Received: March 31, 2010
Last Updated: January 30, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tumor Lysis Syndrome
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Rasburicase
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013