Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224)

Stopped early · Phase 1

Conditions studied: Relapsed Acute Lymphoblastic Leukemia, Allergy to PEG e.Coli Asparaginase, Allergy to Native e.Coli Asparaginase

In brief

This is a phase I study using the Erwinia form of asparaginase in place of the E. coli form using a standard re-induction regimen (Vincristine, Dexamethasone, Doxorubicin) for patients with relapsed ALL who have developed an allergy to the E. coli formulation. This study will administer the drug intravenously instead of the usual intramuscular route. The dose of Erwinia will be escalated in the absence of dose limiting toxicity. Patients must have first or second relapse ALL with a history of prior systemic reaction to E. coli asparaginase.

Key facts

Study ID

NCT00928200

Run by

Therapeutic Advances in Childhood Leukemia Consortium

People needed

1

Starts

2009-04-13

Expected to finish

2010-06-04

Last updated by the study team

2019-02-19

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Prior Stroke Patients with a prior history of asparaginase associated stroke are excluded. Patients with a history of other asparaginase related deep-venous thromboses (including intra-cranial thromboses without evidence of stroke or hemorrhage) are eligible.
• Down Syndrome Patients with Down Syndrome will be excluded.
• Prior Pancreatitis Patients with prior history of Grade 2 or greater asparaginase-induced symptomatic pancreatitis will be excluded.
• Renal Function Patients will be excluded if their serum creatinine is > 1.5 x the upper limit of normal for age at the institution's laboratory.
• Liver/Pancreatic Function
• Patients will be excluded if their lab results are as follows:
• Direct bilirubin > 1.5x the institutional ULN for age. A total bilirubin result that is less than 1.5 times the institutional ULN for age may be used for eligibility if a direct bilirubin result is not available.
• SGPT (ALT) > 4 x institutional ULN
• Amylase or Lipase > 2 x institutional ULN
• Cardiac Function Patients will be excluded if their shortening fraction by echocardiogram is less than the institutional normal for age or an ejection fraction by MUGA is less than the institutional normal for age.
• Infection Patients will be excluded if they have an active uncontrolled infection.
• Patients planning on receiving other investigational agents while on this study. (An investigational agent is defined as any drug not currently approved for use in humans.)
• Patients planning on receiving other anti-cancer therapies while on this study.
• Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
• Patients who have started protocol therapy prior to enrollment. Patient may still enroll if IT therapy was given within 72 hours of study enrollment as part of the diagnostic lumbar procedure.

Where it is running

• Childrens Hospital Los Angeles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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