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Compassionate Use of Erwinase For Pediatric Patients With Acute Lymphoblastic Leukemia Or Non Hodgkins Lymphoma


Phase 1
N/A
N/A
Not Enrolling
Both
Acute Lymphoblastic Leukemia, Non Hodgkins Lymphoma

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Trial Information

Compassionate Use of Erwinase For Pediatric Patients With Acute Lymphoblastic Leukemia Or Non Hodgkins Lymphoma


Primary Objective

To provide Erwinase to patients with acute lymphoblastic leukemia (ALL) or non-Hodgkins
lymphoma who are intolerant or have developed hypersensitivity to E. coli asparaginase
and/or PEG-asparaginase.

TREATMENT PLAN

Erwinia L-asparaginase administration will be given according to the protocol or
non-protocol treatment plan under which the patient is currently being treated.

Erwinase will be discontinued in any patient experiencing an allergic reaction or any Grade
3 or higher adverse event believed to be attributable to this agent.


Inclusion Criteria:



- Patients on treatment for acute lymphoblastic leukemia or non-Hodgkins lymphoma
receiving ALL-type therapy who have developed hypersensitivity or intolerance to E.
coli L-asparaginase or PEG-L-asparaginase or both.

- Informed consent explained to and signed by parent/legal guardian, with emphasis that
although approved for use in Europe and Canada, Erwinase is NOT approved by the
United States Food and Drug Administration

Exclusion Criteria:

- Documented history of severe hypersensitivity or intolerance to Erwinase

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

To provide Erwinase to patients with acute lymphoblastic leukemia (ALL) or non-Hodgkins lymphoma who are intolerant or have developed hypersensitivity to E. coli asparaginase and/or PEG-asparaginase

Outcome Time Frame:

June 2009

Safety Issue:

Yes

Principal Investigator

Sima Jeha, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

ERWASE

NCT ID:

NCT00693602

Start Date:

June 2006

Completion Date:

December 2011

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Non Hodgkins Lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794