Trial Outcomes & Findings for Erwinase Study in Patients With Acute Lymphoblastic Leukemia (NCT NCT00506597)
NCT ID: NCT00506597
Last Updated: 2014-09-11
Results Overview
Toxicity data collected and reported as adverse events during the study period. See Adverse Event section for reporting.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
3 Years
Results posted on
2014-09-11
Participant Flow
The University of Texas (UT) MD Anderson Cancer Center Recruitment Period: May 07, 2007 to November 29, 2011. Recruitment site specifically at MD Anderson Cancer Center medical clinics.
This trial was part of a multi institutional effort by the drug company to make Erwinase available for use. The participants reported were recruited and treated as part of the trial site participation at MD Anderson Cancer Center.
Participant milestones
| Measure |
Erwinase
6 doses of 25,000 Units/m\^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Erwinase Study in Patients With Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Erwinase
n=33 Participants
6 doses of 25,000 Units/m\^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
|
|---|---|
|
Age, Continuous
|
15 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 YearsToxicity data collected and reported as adverse events during the study period. See Adverse Event section for reporting.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 yearsMain 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.
Outcome measures
| Measure |
Erwinase
n=33 Participants
6 doses of 25,000 Units/m\^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
|
|---|---|
|
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
|
33 participants
|
Adverse Events
Erwinase
Serious events: 7 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erwinase
n=33 participants at risk
6 doses of 25,000 Units/m\^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
|
|---|---|
|
Blood and lymphatic system disorders
Hyperglycemia
|
3.0%
1/33 • Adverse event data collected during administration of 6 doses of Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase. Overall study period 3 years and 5 months.
|
|
Blood and lymphatic system disorders
White Blood Count Decreased
|
3.0%
1/33 • Adverse event data collected during administration of 6 doses of Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase. Overall study period 3 years and 5 months.
|
|
Cardiac disorders
Cardiopulmonary Failure
|
3.0%
1/33 • Adverse event data collected during administration of 6 doses of Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase. Overall study period 3 years and 5 months.
|
|
Infections and infestations
Infection
|
12.1%
4/33 • Adverse event data collected during administration of 6 doses of Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase. Overall study period 3 years and 5 months.
|
Other adverse events
| Measure |
Erwinase
n=33 participants at risk
6 doses of 25,000 Units/m\^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
|
|---|---|
|
Immune system disorders
Allergic Reaction
|
3.0%
1/33 • Adverse event data collected during administration of 6 doses of Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase. Overall study period 3 years and 5 months.
|
|
Infections and infestations
Fever/Infection
|
3.0%
1/33 • Adverse event data collected during administration of 6 doses of Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase. Overall study period 3 years and 5 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
3.0%
1/33 • Adverse event data collected during administration of 6 doses of Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase. Overall study period 3 years and 5 months.
|
|
Musculoskeletal and connective tissue disorders
Parathesia
|
3.0%
1/33 • Adverse event data collected during administration of 6 doses of Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase. Overall study period 3 years and 5 months.
|
|
Musculoskeletal and connective tissue disorders
Facial Weakness
|
3.0%
1/33 • Adverse event data collected during administration of 6 doses of Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase. Overall study period 3 years and 5 months.
|
|
General disorders
Headache
|
3.0%
1/33 • Adverse event data collected during administration of 6 doses of Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase. Overall study period 3 years and 5 months.
|
|
Blood and lymphatic system disorders
Prothrombin time (PTT) increased
|
3.0%
1/33 • Adverse event data collected during administration of 6 doses of Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase. Overall study period 3 years and 5 months.
|
|
Endocrine disorders
Pancreatitis
|
3.0%
1/33 • Adverse event data collected during administration of 6 doses of Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase. Overall study period 3 years and 5 months.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
3.0%
1/33 • Adverse event data collected during administration of 6 doses of Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase. Overall study period 3 years and 5 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.0%
1/33 • Adverse event data collected during administration of 6 doses of Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase. Overall study period 3 years and 5 months.
|
Additional Information
Robert J. Wells, MD / Professor
The University of Texas (UT) MD Anderson Cancer Center
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place