Erwinia Asparaginase After Allergy to PEG-Asparaginase in Treating Young Patients With Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT00537030|
Recruitment Status : Completed
First Posted : September 28, 2007
Results First Posted : August 22, 2014
Last Update Posted : July 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Adult Acute Lymphoblastic Leukemia Childhood Acute Lymphoblastic Leukemia||Drug: Asparaginase Other: Laboratory Biomarker Analysis Other: Pharmacological Study||Not Applicable|
I. To determine if the 48-hour trough serum asparaginase activity is ? 0.1 IU/mL in young patients with acute lymphoblastic leukemia treated with Erwinia asparaginase after allergy to PEG-asparaginase.
II. To determine the frequency of asparaginase-related toxicity in these patients.
III. To characterize the pharmacokinetics of Erwinia asparaginase in these patients.
I. To compare serum asparaginase activity and serum asparagine concentration between patients treated with Erwinia asparaginase on this trial and historical controls treated with PEG-asparaginase on CCG-1961 and CCG-1962.
II. To determine the 72-hour serum asparaginase activity on days 8 or 11 or 13 based on the starting date of Erwinia asparaginase therapy.
III. To determine the presence of anti-Erwinia asparaginase antibodies in patients treated with a course(s) of Erwinia asparaginase following clinical allergy to PEG-asparaginase (PEG, pegaspargase).
IV. To determine if serum asparagine is adequately depleted on days 12 or 13 in a subset of these patients.
OUTLINE: This is a multicenter study.
Patients receive 6 doses of Erwinia asparaginase intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.
Blood samples are collected periodically for pharmacokinetic, pharmacodynamic, and antibody studies.
After completion of study treatment, patients are followed periodically.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacology and Toxicity of Erwinia Asparaginase (Erwinase?; Crisantaspase; IND 290) Following Allergy to PEG-Asparaginase in Treatment of Children With Acute Lymphoblastic Leukemia (ALL)|
|Actual Study Start Date :||February 11, 2008|
|Actual Primary Completion Date :||February 1, 2011|
Experimental: Treatment (chemotherapy)
Patients receive 6 doses of Erwinia asparaginase IM on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- Percentage of Participants With Trough Serum Asparaginase Activity ≥ 0.1 IU/mL [ Time Frame: 48 hours post administration of Erwinia asparaginase ]Percentage of participants who had trough serum asparaginase activity ≥ 0.1 IU/mL in the blood 48 hours post administration of Erwinia asparaginase
- Determine if Plasma Asparagine is Adequately Depleted [ Time Frame: On days 12 or 13 ]Plasma asparagine depletion will be determined in a subset of 20 patients limited to participating Phase I Institutions.
- Presence of Anti-Erwinia Asparaginase Antibodies in Children Treated With a Course(s) of Erwinase® Following Clinical Allergy to PEG-asparaginase [ Time Frame: At baseline, prior to doses 4, 5, and 6 and on days 15 and 22 ]An ELISA (enzyme-linked immunosorbent assay) method will be used to determine the presence of specific anti-Erwinia and anti-PEG-asparaginase antibodies at baseline, and of specific anti-Erwinia asparaginase antibodies after first and subsequent exposures to Erwinase®. The rate of antibody formation will be described and compared informally to experience in CCG-1962 and 1961. Serum asparaginase activity will be compared during Erwinase® courses as an indication of the neutralizing effect of antibodies on the enzyme effect.
- Percentage of Participants Who Experienced Toxicities [ Time Frame: up to 1 year ]The percentage of participants who experienced toxicities: Allergy rate, Hyperglycemia Rate, Pancreatitis Rate, Hemorrhage/Thrombosis Rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00537030
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|Principal Investigator:||Wanda Salzer||Children's Oncology Group|