NCT00506597

Brief Summary

The goal of this clinical research study is to allow doctors to use Erwinia L-Asparaginase (Erwinase®) as a replacement for patients who are allergic to E.coli L-asparaginase or Pegylated E.coli L-asparaginase as part of the treatment for acute lymphoblastic leukemia (ALL) or T or B cell lymphoma. This trial was part of a multi institutional effort by the drug company to make Erwinase available for use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable leukemia

Timeline
Completed

Started May 2007

Typical duration for not_applicable leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

September 11, 2014

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

4.8 years

First QC Date

July 20, 2007

Results QC Date

October 17, 2013

Last Update Submit

September 4, 2014

Conditions

Leukemia

Keywords

Acute Lymphoblastic LeukemiaLeukemiaErwinia L-AsparaginaseErwinase

Outcome Measures

Primary Outcomes (2)

  • Participant Toxicity Data

    Toxicity data collected and reported as adverse events during the study period. See Adverse Event section for reporting.

    3 Years

  • Number of Participants Treated With Erwinase as a Replacement for E.Coli L-asparaginase or Pegylated E.Coli L-asparaginase as Part of the Treatment for Acute Lymphoblastic Leukemia (ALL) or T or B Cell Lymphoma

    Main objective of protocol Erwinase® Master Treatment Protocol (EMTP) was to enable United States (US) participants who were treated for Acute Lymphoblastic Leukemia (ALL) and who were allergic to Escherichia coli derived L-Asparaginase, whatever the formulation, to be treated with Erwinia derived L-Asparaginase (Erwinase®), under Investigational New Drug (IND) 290.

    4 years

Study Arms (1)

Erwinase

EXPERIMENTAL

6 doses of 25,000 Units/m\^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase

Drug: Erwinase

Interventions

ErwinaseDRUG

If allergic to E.Coli Asparaginase = 1 Dose (20,000 Units/m\^2) Daily; If allergic to Pegylated Asparaginase = 6 Doses (25,000 Units/m\^2) Daily Every Other Day. Received as an injection through a needle in vein, under the skin, or in muscle.

Also known as: Erwinia L-Asparaginase
Erwinase

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age: no restrictions
  • Patient must give written informed consent to receive Erwinase® under Investigational New Drug (IND) 290.
  • Patient must be treated for Acute Lymphoblastic Leukemia
  • Patient with either T or B cell lymphoma being treated with Asparaginase.
  • Patient must have either systemic hypersensitivity reactions to native (Elspar®) or pegylated (Oncaspar®) E. coli L-Asparaginase. This includes patients with generalized rash with or without anaphylactic symptoms, but not those with only local pain or redness at the site of injection.
  • Patient with previously documented local or systemic reactions to E. coli derived L-Asparaginase.
  • Patients who are on Elspar® (including those enrolled in a clinical trial randomized to Elspar®) and where Elspar® is not available.

You may not qualify if:

  • Previous allergic reaction to Erwinia L-Asparaginase (Erwinase ®)
  • Previous acute pancreatitis
  • Pregnant or lactating woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Asparaginaseasparaginase erwinia chrysanthemi recombinant

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

AmidohydrolasesHydrolasesEnzymesEnzymes and Coenzymes

Results Point of Contact

Title
Robert J. Wells, MD / Professor
Organization
The University of Texas (UT) MD Anderson Cancer Center
CR_Study_Registration@mdanderson.org

Study Officials

  • Robert J. Wells, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2007

First Posted

July 25, 2007

Study Start

May 1, 2007

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

September 11, 2014

Results First Posted

September 11, 2014

Record last verified: 2014-09

Locations

US(1)