Trial Outcomes & Findings for LSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma (NCT NCT00610883)
NCT ID: NCT00610883
Last Updated: 2023-09-28
Results Overview
The number of patients who achieved a complete remission as a result of treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
330 Days
Results posted on
2023-09-28
Participant Flow
Participant milestones
| Measure |
All Patients
LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma
Baseline characteristics by cohort
| Measure |
All Patients
n=17 Participants
LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
|
|---|---|
|
Age, Customized
Median Age
|
12 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 330 DaysThe number of patients who achieved a complete remission as a result of treatment
Outcome measures
| Measure |
All Patients
n=17 Participants
LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
|
|---|---|
|
Complete Remission
|
10 participants
|
Adverse Events
All Patients
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=17 participants at risk
LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
|
|---|---|
|
Cardiac disorders
Ruptured Necrotic Tumor
|
5.9%
1/17 • Number of events 1
|
Other adverse events
| Measure |
All Patients
n=17 participants at risk
LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
|
|---|---|
|
Blood and lymphatic system disorders
Hematological Toxicity
|
100.0%
17/17 • Number of events 17
|
|
Renal and urinary disorders
Hepatic Toxicity
|
100.0%
17/17 • Number of events 17
|
Additional Information
Dr. Tanya Trippett
Memorial Sloan Kettering Cancer Center
Phone: 212-639-8267
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place