Trial Outcomes & Findings for Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224) (NCT NCT00928200)
NCT ID: NCT00928200
Last Updated: 2019-02-19
Results Overview
The MTD in each stratum will be the highest dose at which 1 or fewer of six patients experience DLT during cycle 1 of therapy.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
1 participants
Primary outcome timeframe
Beginning with the first dose of investigational product until 30 days following the last dose of Erwinase
Results posted on
2019-02-19
Participant Flow
Participant milestones
| Measure |
Single Arm
All patients receive Vincristine, Dexamethasone, Doxorubicin, and Cytarabine. Dexrazoxane optional on Day 1. Erwinase is started between Days 3-5 and is given every M-W-F for a total of 10 doses. Patients with CNS 1 or 2 receive Methotrexate intrathecally on Day 15. Patients with CNS 3 receive Triple Intrathecal Therapy (Methotrexate, Cytarabine and Hydrocortisone) on Days 8, 15, and 22.
Erwinase: The dose of Erwinase will be assigned at study entry. The first dose of Erwinase wil be given between Days 3-5 and will continue on a M-W-F schedule for a total of 10 doses.
Erwinase will be administered as a 2-hour intravenous infusion.
Vincristine: 1.5 mg/m2/dose IV push (maximum single dose 2 mg) on Days 1, 8, 15 and 22
Dexamethasone: 10 mg/m2/day divided BID. Give by mouth days 1-14.
Doxorubicin: 60 mg/m2/day IV over 15 minutes on day 1
Cytarabine: Given Intrathecally at the dose defined by age on day 1. 30 mg for age 1-1.99 50 mg for age 2-2.99 70 mg for age 3
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224)
Baseline characteristics by cohort
| Measure |
Single Arm
n=1 Participants
All patients receive Vincristine, Dexamethasone, Doxorubicin, and Cytarabine. Dexrazoxane optional on Day 1. Erwinase is started between Days 3-5 and is given every M-W-F for a total of 10 doses. Patients with CNS 1 or 2 receive Methotrexate intrathecally on Day 15. Patients with CNS 3 receive Triple Intrathecal Therapy (Methotrexate, Cytarabine and Hydrocortisone) on Days 8, 15, and 22.
Erwinase: The dose of Erwinase will be assigned at study entry. The first dose of Erwinase wil be given between Days 3-5 and will continue on a M-W-F schedule for a total of 10 doses.
Erwinase will be administered as a 2-hour intravenous infusion.
Vincristine: 1.5 mg/m2/dose IV push (maximum single dose 2 mg) on Days 1, 8, 15 and 22
Dexamethasone: 10 mg/m2/day divided BID. Give by mouth days 1-14.
Doxorubicin: 60 mg/m2/day IV over 15 minutes on day 1
Cytarabine: Given Intrathecally at the dose defined by age on day 1. 30 mg for age 1-1.99 50 mg for age 2-2.99 70 mg for age 3
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Beginning with the first dose of investigational product until 30 days following the last dose of ErwinaseThe MTD in each stratum will be the highest dose at which 1 or fewer of six patients experience DLT during cycle 1 of therapy.
Outcome measures
| Measure |
Single Arm
n=1 Participants
All patients receive Vincristine, Dexamethasone, Doxorubicin, and Cytarabine. Dexrazoxane optional on Day 1. Erwinase is started between Days 3-5 and is given every M-W-F for a total of 10 doses. Patients with CNS 1 or 2 receive Methotrexate intrathecally on Day 15. Patients with CNS 3 receive Triple Intrathecal Therapy (Methotrexate, Cytarabine and Hydrocortisone) on Days 8, 15, and 22.
Erwinase: The dose of Erwinase will be assigned at study entry. The first dose of Erwinase wil be given between Days 3-5 and will continue on a M-W-F schedule for a total of 10 doses.
Erwinase will be administered as a 2-hour intravenous infusion.
Vincristine: 1.5 mg/m2/dose IV push (maximum single dose 2 mg) on Days 1, 8, 15 and 22
Dexamethasone: 10 mg/m2/day divided BID. Give by mouth days 1-14.
Doxorubicin: 60 mg/m2/day IV over 15 minutes on day 1
Cytarabine: Given Intrathecally at the dose defined by age on day 1. 30 mg for age 1-1.99 50 mg for age 2-2.99 70 mg for age 3
|
|---|---|
|
Occurrence of a Dose-Limiting Toxicity
|
0 Participants
|
SECONDARY outcome
Timeframe: After completion of treatment coursePopulation: Study closed early due to lack of accrual, and insufficient data were collected for performing this analysis.
Disease response evaluated by examination and labs. MRD evaluated from marrow samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PK samples to be collected Pre-Tx, and and Erwinase Doses 3, 6 and 9 and Day 29Population: Study closed early due to lack of accrual and insufficient data were collected to perform this analysis.
Activity levels assessed from PK sampling
Outcome measures
Outcome data not reported
Adverse Events
Single Arm
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm
n=1 participants at risk
All patients receive Vincristine, Dexamethasone, Doxorubicin, and Cytarabine. Dexrazoxane optional on Day 1. Erwinase is started between Days 3-5 and is given every M-W-F for a total of 10 doses. Patients with CNS 1 or 2 receive Methotrexate intrathecally on Day 15. Patients with CNS 3 receive Triple Intrathecal Therapy (Methotrexate, Cytarabine and Hydrocortisone) on Days 8, 15, and 22.
Erwinase: The dose of Erwinase will be assigned at study entry. The first dose of Erwinase wil be given between Days 3-5 and will continue on a M-W-F schedule for a total of 10 doses.
Erwinase will be administered as a 2-hour intravenous infusion.
Vincristine: 1.5 mg/m2/dose IV push (maximum single dose 2 mg) on Days 1, 8, 15 and 22
Dexamethasone: 10 mg/m2/day divided BID. Give by mouth days 1-14.
Doxorubicin: 60 mg/m2/day IV over 15 minutes on day 1
Cytarabine: Given Intrathecally at the dose defined by age on day 1. 30 mg for age 1-1.99 50 mg for age 2-2.99 70 mg for age 3
|
|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
1/1 • 6 months
The definition of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
1/1 • 6 months
The definition of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
Other adverse events
| Measure |
Single Arm
n=1 participants at risk
All patients receive Vincristine, Dexamethasone, Doxorubicin, and Cytarabine. Dexrazoxane optional on Day 1. Erwinase is started between Days 3-5 and is given every M-W-F for a total of 10 doses. Patients with CNS 1 or 2 receive Methotrexate intrathecally on Day 15. Patients with CNS 3 receive Triple Intrathecal Therapy (Methotrexate, Cytarabine and Hydrocortisone) on Days 8, 15, and 22.
Erwinase: The dose of Erwinase will be assigned at study entry. The first dose of Erwinase wil be given between Days 3-5 and will continue on a M-W-F schedule for a total of 10 doses.
Erwinase will be administered as a 2-hour intravenous infusion.
Vincristine: 1.5 mg/m2/dose IV push (maximum single dose 2 mg) on Days 1, 8, 15 and 22
Dexamethasone: 10 mg/m2/day divided BID. Give by mouth days 1-14.
Doxorubicin: 60 mg/m2/day IV over 15 minutes on day 1
Cytarabine: Given Intrathecally at the dose defined by age on day 1. 30 mg for age 1-1.99 50 mg for age 2-2.99 70 mg for age 3
|
|---|---|
|
Nervous system disorders
Agitation
|
100.0%
1/1 • 6 months
The definition of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
1/1 • 6 months
The definition of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Investigations
Blood fibrinogen
|
100.0%
1/1 • 6 months
The definition of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
100.0%
1/1 • 6 months
The definition of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
1/1 • 6 months
The definition of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
100.0%
1/1 • 6 months
The definition of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
1/1 • 6 months
The definition of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
100.0%
1/1 • 6 months
The definition of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
100.0%
1/1 • 6 months
The definition of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Injury, poisoning and procedural complications
Injection site reaction NOS
|
100.0%
1/1 • 6 months
The definition of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Blood and lymphatic system disorders
Leukopenia NOS
|
100.0%
1/1 • 6 months
The definition of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Blood and lymphatic system disorders
Neutrophil count
|
100.0%
1/1 • 6 months
The definition of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
100.0%
1/1 • 6 months
The definition of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
100.0%
1/1 • 6 months
The definition of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Vomiting NOS
|
100.0%
1/1 • 6 months
The definition of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
Additional Information
Peggy Romano, BA, CCRP
Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) / Children's Hospital Los Angeles
Phone: 323-361-5505
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60