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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Rasburicase
Antirheumatic Agents
Gout Suppressants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014