TerminatedNot Applicable

Elitek (Rasburicase) Immuno-Monitoring Study

Stopped: business decision due to low subject recruitment

United States1 participantsStarted 2010-02

Plain-language 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.

Who can participate

Age range2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. Loss of uricolytic activity can be defined as:
✓. 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

✕. 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.

What they're measuring

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

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

Trial details

NCT IDNCT01097369

SponsorSanofi

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2010-02

View on ClinicalTrials.gov More Tumor Lysis Syndrome trials

Plain-language summary

Who can participate

Age range2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. Loss of uricolytic activity can be defined as:
✓. 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

✕. 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.

What they're measuring

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

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