Trial Outcomes & Findings for Four Drug Reinduction With Bortezomib for Relapsed or Refractory ALL or LL in Children and Young Adults (NCT NCT02535806)
NCT ID: NCT02535806
Last Updated: 2019-08-13
Results Overview
Toxicities were assessed and graded according to CTCAE v 4.0.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
36 days
Results posted on
2019-08-13
Participant Flow
Participant milestones
| Measure |
Treatment Arm
Velcade will be given IV push on days 1,4,8 and 11 at a dose of 1.3 mg/m2/dose. At least 72 hours must have relapsed between doses.
IT Methotrexate (CNS Negative patients only) on days 1 and 8; age based dosing IT Methotrexate/Hydrocortisone/AraC (CNS positive patients only) on days 1, 8, 15 and 22; age based dosing.
Dexamethasone: Days 1-5 and 15-19; 10mg/m2/dose PO BID. Mitoxantrone: Days 1 and 2; 10mg/m2/dose Vincristine: days 1, 8, 15, and 22 at 1.5 mg/m2 (Maximum dose 2 mg) PEG-asparaginase: Days 3 and 17, 2500 IU/m2/dose
Velcade: 4 doses of study drug will be given.
Methotrexate: Intrathecal dose For CNS negative patients, Day 1 and Day 8
Methotrexate / Hydrocortisone / Cytarabine: Intrathecal dose for CNS positive patients, Day 1, 8, 15, 22
Dexamethasone: Days 1-5 and 15-19
Mitoxantrone: Days 1 and 2
Vincristine: Days 1, 8, 15, 22
Pegaspargase: Days 3 and 17
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Four Drug Reinduction With Bortezomib for Relapsed or Refractory ALL or LL in Children and Young Adults
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=2 Participants
Velcade will be given IV push on days 1,4,8 and 11 at a dose of 1.3 mg/m2/dose. At least 72 hours must have relapsed between doses.
IT Methotrexate (CNS Negative patients only) on days 1 and 8; age based dosing IT Methotrexate/Hydrocortisone/AraC (CNS positive patients only) on days 1, 8, 15 and 22; age based dosing.
Dexamethasone: Days 1-5 and 15-19; 10mg/m2/dose PO BID. Mitoxantrone: Days 1 and 2; 10mg/m2/dose Vincristine: days 1, 8, 15, and 22 at 1.5 mg/m2 (Maximum dose 2 mg) PEG-asparaginase: Days 3 and 17, 2500 IU/m2/dose
Velcade: 4 doses of study drug will be given.
Methotrexate: Intrathecal dose For CNS negative patients, Day 1 and Day 8
Methotrexate / Hydrocortisone / Cytarabine: Intrathecal dose for CNS positive patients, Day 1, 8, 15, 22
Dexamethasone: Days 1-5 and 15-19
Mitoxantrone: Days 1 and 2
Vincristine: Days 1, 8, 15, 22
Pegaspargase: Days 3 and 17
|
|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 daysToxicities were assessed and graded according to CTCAE v 4.0.
Outcome measures
| Measure |
Treatment Arm
n=2 Participants
Velcade will be given IV push on days 1,4,8 and 11 at a dose of 1.3 mg/m2/dose. At least 72 hours must have relapsed between doses.
IT Methotrexate (CNS Negative patients only) on days 1 and 8; age based dosing IT Methotrexate/Hydrocortisone/AraC (CNS positive patients only) on days 1, 8, 15 and 22; age based dosing.
Dexamethasone: Days 1-5 and 15-19; 10mg/m2/dose PO BID. Mitoxantrone: Days 1 and 2; 10mg/m2/dose Vincristine: days 1, 8, 15, and 22 at 1.5 mg/m2 (Maximum dose 2 mg) PEG-asparaginase: Days 3 and 17, 2500 IU/m2/dose
Velcade: 4 doses of study drug will be given.
Methotrexate: Intrathecal dose For CNS negative patients, Day 1 and Day 8
Methotrexate / Hydrocortisone / Cytarabine: Intrathecal dose for CNS positive patients, Day 1, 8, 15, 22
Dexamethasone: Days 1-5 and 15-19
Mitoxantrone: Days 1 and 2
Vincristine: Days 1, 8, 15, 22
Pegaspargase: Days 3 and 17
|
|---|---|
|
Number of Subject With Adverse Events
|
1 Participants
|
SECONDARY outcome
Timeframe: 36 daysNumber of patients with bone marrow blast percentage \<5% after treatment
Outcome measures
| Measure |
Treatment Arm
n=2 Participants
Velcade will be given IV push on days 1,4,8 and 11 at a dose of 1.3 mg/m2/dose. At least 72 hours must have relapsed between doses.
IT Methotrexate (CNS Negative patients only) on days 1 and 8; age based dosing IT Methotrexate/Hydrocortisone/AraC (CNS positive patients only) on days 1, 8, 15 and 22; age based dosing.
Dexamethasone: Days 1-5 and 15-19; 10mg/m2/dose PO BID. Mitoxantrone: Days 1 and 2; 10mg/m2/dose Vincristine: days 1, 8, 15, and 22 at 1.5 mg/m2 (Maximum dose 2 mg) PEG-asparaginase: Days 3 and 17, 2500 IU/m2/dose
Velcade: 4 doses of study drug will be given.
Methotrexate: Intrathecal dose For CNS negative patients, Day 1 and Day 8
Methotrexate / Hydrocortisone / Cytarabine: Intrathecal dose for CNS positive patients, Day 1, 8, 15, 22
Dexamethasone: Days 1-5 and 15-19
Mitoxantrone: Days 1 and 2
Vincristine: Days 1, 8, 15, 22
Pegaspargase: Days 3 and 17
|
|---|---|
|
Remission Rate Seen With Using Bortezomib in Combination With the ALL R3 Re-induction Regimen in Pediatric Patients With Relapsed or Refractory ALL or LL.
|
2 Participants
|
SECONDARY outcome
Timeframe: 36 daysPercent of Cells Positive for Minimal residual disease measured by multiparameter flow cytometry
Outcome measures
| Measure |
Treatment Arm
n=2 Participants
Velcade will be given IV push on days 1,4,8 and 11 at a dose of 1.3 mg/m2/dose. At least 72 hours must have relapsed between doses.
IT Methotrexate (CNS Negative patients only) on days 1 and 8; age based dosing IT Methotrexate/Hydrocortisone/AraC (CNS positive patients only) on days 1, 8, 15 and 22; age based dosing.
Dexamethasone: Days 1-5 and 15-19; 10mg/m2/dose PO BID. Mitoxantrone: Days 1 and 2; 10mg/m2/dose Vincristine: days 1, 8, 15, and 22 at 1.5 mg/m2 (Maximum dose 2 mg) PEG-asparaginase: Days 3 and 17, 2500 IU/m2/dose
Velcade: 4 doses of study drug will be given.
Methotrexate: Intrathecal dose For CNS negative patients, Day 1 and Day 8
Methotrexate / Hydrocortisone / Cytarabine: Intrathecal dose for CNS positive patients, Day 1, 8, 15, 22
Dexamethasone: Days 1-5 and 15-19
Mitoxantrone: Days 1 and 2
Vincristine: Days 1, 8, 15, 22
Pegaspargase: Days 3 and 17
|
|---|---|
|
Post-induction Level of Minimal Residual Disease Seen With Using Bortezomib in Combination With the ALL R3 Re-induction Regimen in Pediatric Patients With Relapsed or Refractory ALL or LL.
|
0.65 Percentage of Cells Positive for MRD
Interval 0.0 to 1.3
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Treatment Arm
n=2 Participants
Velcade will be given IV push on days 1,4,8 and 11 at a dose of 1.3 mg/m2/dose. At least 72 hours must have relapsed between doses.
IT Methotrexate (CNS Negative patients only) on days 1 and 8; age based dosing IT Methotrexate/Hydrocortisone/AraC (CNS positive patients only) on days 1, 8, 15 and 22; age based dosing.
Dexamethasone: Days 1-5 and 15-19; 10mg/m2/dose PO BID. Mitoxantrone: Days 1 and 2; 10mg/m2/dose Vincristine: days 1, 8, 15, and 22 at 1.5 mg/m2 (Maximum dose 2 mg) PEG-asparaginase: Days 3 and 17, 2500 IU/m2/dose
Velcade: 4 doses of study drug will be given.
Methotrexate: Intrathecal dose For CNS negative patients, Day 1 and Day 8
Methotrexate / Hydrocortisone / Cytarabine: Intrathecal dose for CNS positive patients, Day 1, 8, 15, 22
Dexamethasone: Days 1-5 and 15-19
Mitoxantrone: Days 1 and 2
Vincristine: Days 1, 8, 15, 22
Pegaspargase: Days 3 and 17
|
|---|---|
|
2-year Overall Survival Seen With Using Bortezomib in Combination With the ALL R3 Re-induction Regimen in Pediatric Patients With Relapsed or Refractory ALL or LL.
|
1 Participants
|
Adverse Events
Treatment Arm
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Arm
n=2 participants at risk
Velcade will be given IV push on days 1,4,8 and 11 at a dose of 1.3 mg/m2/dose. At least 72 hours must have relapsed between doses.
IT Methotrexate (CNS Negative patients only) on days 1 and 8; age based dosing IT Methotrexate/Hydrocortisone/AraC (CNS positive patients only) on days 1, 8, 15 and 22; age based dosing.
Dexamethasone: Days 1-5 and 15-19; 10mg/m2/dose PO BID. Mitoxantrone: Days 1 and 2; 10mg/m2/dose Vincristine: days 1, 8, 15, and 22 at 1.5 mg/m2 (Maximum dose 2 mg) PEG-asparaginase: Days 3 and 17, 2500 IU/m2/dose
Velcade: 4 doses of study drug will be given.
Methotrexate: Intrathecal dose For CNS negative patients, Day 1 and Day 8
Methotrexate / Hydrocortisone / Cytarabine: Intrathecal dose for CNS positive patients, Day 1, 8, 15, 22
Dexamethasone: Days 1-5 and 15-19
Mitoxantrone: Days 1 and 2
Vincristine: Days 1, 8, 15, 22
Pegaspargase: Days 3 and 17
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
50.0%
1/2 • Number of events 1 • 36 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place