Trial · NCT00506597

Erwinase Study in Patients With Acute Lymphoblastic Leukemia

NCT00506597, Not applicable, Completed, M.D. Anderson Cancer Center; results first posted 2014-09-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Erwinase Study in Patients With Acute Lymphoblastic Leukemia. Trials, record NCT00506597. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00506597

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Erwinase Study in Patients With Acute Lymphoblastic Leukemia
NCT number: NCT00506597
Status: Completed
Phases: Not applicable
Enrollment: 33 participants, actual
Lead sponsor: M.D. Anderson Cancer Center
Conditions: Leukemia
Interventions: Erwinase
First posted: 2007-07-25
Last updated: 2014-09-11
Results first posted: 2014-09-11

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Participant Toxicity Data	3 Years	Toxicity data collected and reported as adverse events during the study period. See Adverse Event section for reporting.
Primary	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	4 years	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Participant Toxicity Data	3 Years
PRIMARY	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	4 years		participants	NUMBER

Source ClinicalTrials.gov

Results by group1

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
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	Erwinase		33		participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Erwinase	33
Overall Study	COMPLETED	Erwinase	33
Overall Study	NOT COMPLETED	Erwinase	0

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Allergic Reaction	Immune system disorders	Erwinase	1	33
other	Fever/Infection	Infections and infestations	Erwinase	1	33
other	Muscle Weakness	Musculoskeletal and connective tissue disorders	Erwinase	1	33
other	Parathesia	Musculoskeletal and connective tissue disorders	Erwinase	1	33
other	Facial Weakness	Musculoskeletal and connective tissue disorders	Erwinase	1	33
other	Headache	General disorders	Erwinase	1	33
other	Prothrombin time (PTT) increased	Blood and lymphatic system disorders	Erwinase	1	33
other	Pancreatitis	Endocrine disorders	Erwinase	1	33
other	Pancytopenia	Blood and lymphatic system disorders	Erwinase	1	33
other	Hypokalemia	Metabolism and nutrition disorders	Erwinase	1	33

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Erwinase
Total, other adverse events	Erwinase	6	33
Total, serious adverse events	Erwinase	7	33

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00506597

GET https://conductscience.org/api/trials/v1/NCT00506597/registered

API reference For AI assistants