Trial Outcomes & Findings for Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL (NCT NCT00981799)
NCT ID: NCT00981799
Last Updated: 2020-10-01
Results Overview
Patients will be evaluated based on Dose Level and total courses taken at each dose level and for presence of dose limiting toxicities. Not all patients enrolled at each dose level has been assessed to be evaluable for DLTs. Only those that have met criteria for being evaluable for DLT will be counted in the Overall Number of Participants Analyzed.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
23 participants
Primary outcome timeframe
6 months
Results posted on
2020-10-01
Participant Flow
Participant milestones
| Measure |
Nelarabine Dose Level 1
The study will begin at Dose Level 1 at 480 mg/m2 Nelarabine (75% of single agent maximum tolerated dose) and 330 mg/m2 Cyclophospamide and will escalate to the next Dose Level if the maximum tolerated dose (MTD) is not exceeded.
Nelarabine: Dose will be assigned at study entry. Nelarabine will be given IV over
|
Nelarabine Dose Level 2
Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 330 mg/m2 Cyclophosphamide.
|
Nelarabine Dose Level 3
Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 400 mg/m2 Cyclophosphamide
|
Nelarabine Dose Level 0
Patients in this arm will be administered Nelarabine 325 mg/m2 (50% of single agent MTD) and 330 mg/2 Cyclophosphamide. Patients will only enter this arm if the MTD at Dose Level 1 has been exceeded. If the MTD is exceeded at Dose Level 0, the study will be closed.
Nelarabine: Dose will be assigned at study entry. Nelarabine will be given IV over 60 minutes (given at hours 0 to 1) on days 1 through 5.
Etoposide: 100 mg/m2/day IV over 2 hours (given at hours 1 to 3) on days 1 through 5
Cyclophosphamide: Dose will be assigned at study entry, IV as a 30-60 minute infusion (given at hours 3 to 4) on days 1 through 5.
Methotrexate: Give between day 29 and 36 or when ANC\>750 and PLTS\>75,000 - whichever comes first (but not prior to day 22) at the dose defined by age below, ideally in conjunction with BM evaluation.
Given intrathecally at the dose defined by age below. 8 mg for patients age greater than or equal to 1, but \<2 years of age 10 mg for patients age greater than
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
10
|
0
|
|
Overall Study
COMPLETED
|
5
|
6
|
10
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Nelarabine Dose Level 1
The study will begin at Dose Level 1 at 480 mg/m2 Nelarabine (75% of single agent maximum tolerated dose) and 330 mg/m2 Cyclophospamide and will escalate to the next Dose Level if the maximum tolerated dose (MTD) is not exceeded.
Nelarabine: Dose will be assigned at study entry. Nelarabine will be given IV over
|
Nelarabine Dose Level 2
Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 330 mg/m2 Cyclophosphamide.
|
Nelarabine Dose Level 3
Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 400 mg/m2 Cyclophosphamide
|
Nelarabine Dose Level 0
Patients in this arm will be administered Nelarabine 325 mg/m2 (50% of single agent MTD) and 330 mg/2 Cyclophosphamide. Patients will only enter this arm if the MTD at Dose Level 1 has been exceeded. If the MTD is exceeded at Dose Level 0, the study will be closed.
Nelarabine: Dose will be assigned at study entry. Nelarabine will be given IV over 60 minutes (given at hours 0 to 1) on days 1 through 5.
Etoposide: 100 mg/m2/day IV over 2 hours (given at hours 1 to 3) on days 1 through 5
Cyclophosphamide: Dose will be assigned at study entry, IV as a 30-60 minute infusion (given at hours 3 to 4) on days 1 through 5.
Methotrexate: Give between day 29 and 36 or when ANC\>750 and PLTS\>75,000 - whichever comes first (but not prior to day 22) at the dose defined by age below, ideally in conjunction with BM evaluation.
Given intrathecally at the dose defined by age below. 8 mg for patients age greater than or equal to 1, but \<2 years of age 10 mg for patients age greater than
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL
Baseline characteristics by cohort
| Measure |
Nelarabine Dose Level 1
n=6 Participants
The study will begin at Dose Level 1 at 480 mg/m2 Nelarabine (75% of single agent MTD) and 330 mg/m2 Cyclophosphamide. The first 3 patients will be enrolled into Dose Level 1.
If 0/3 experiences dose limiting toxicity (DLT) at a given dose level, then the dose is escalated to the next higher level and 3 more patients are enrolled. If 1/3 experiences DLT at current dose, the up to 3 more patients are accrued at the same dose level. If 2 or more DLTs are observed in a 3-patient or 6-patient cohort at a given dose level, then the MTD has been exceeded, dose escalation will be stopped, and up to 3 additional patients will be enrolled at the next lower dose level (unless 6 patients have already been treated at that prior dose). If the MTD is exceeded at Dose Level 0, the study will be closed.
|
Nelarabine Dose Level 2
n=7 Participants
Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 330 mg/m2 Cyclophosphamide.
This is the second dose level of this dose escalation study. If 1 or fewer patients at Dose Level 1 experiences a DLT, patients will be accrued at Dose Level 2.
If 0/3 experiences dose limiting toxicity (DLT) at a given dose level, then the dose is escalated to the next higher level and 3 more patients are enrolled. If 1/3 experiences DLT at current dose, the up to 3 more patients are accrued at the same dose level. If 2 or more DLTs are observed in a 3-patient or 6-patient cohort at a given dose level, then the MTD has been exceeded, dose escalation will be stopped, and up to 3 additional patients will be enrolled at the next lower dose level (unless 6 patients have already been treated at that prior dose). If the MTD is exceeded at Dose Level 0, the study will be closed.
|
Nelarabine Dose Level 3
n=10 Participants
Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 400 mg/m2 Cyclophosphamide This is the third and final dose level of this dose escalation study. If 1 or fewer patients at Dose Level 2 experiences a DLT, patients will be accrued at Dose Level 3.
If 0/3 experiences dose limiting toxicity (DLT) at a given dose level, then the dose is escalated to the next higher level and 3 more patients are enrolled. If 1/3 experiences DLT at current dose, the up to 3 more patients are accrued at the same dose level. If 2 or more DLTs are observed in a 3-patient or 6-patient cohort at a given dose level, then the MTD has been exceeded, dose escalation will be stopped, and up to 3 additional patients will be enrolled at the next lower dose level (unless 6 patients have already been treated at that prior dose). If the MTD is exceeded at Dose Level 0, the study will be closed.
|
Nelarabine Dose Level 0
Patients in this arm will be administered Nelarabine 325 mg/m2 (50% of single agent MTD) and 330 mg/2 Cyclophosphamide. Patients will only enter this arm if the MTD at Dose Level 1 has been exceeded. If the MTD is exceeded at Dose Level 0, the study will be closed.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
13 years
n=5 Participants
|
7 years
n=7 Participants
|
10.5 years
n=5 Participants
|
—
|
9 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
—
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
—
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
—
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
—
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
—
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: There are 0 patients for Dose Level 0 as no patients met the criteria to be enrolled
Patients will be evaluated based on Dose Level and total courses taken at each dose level and for presence of dose limiting toxicities. Not all patients enrolled at each dose level has been assessed to be evaluable for DLTs. Only those that have met criteria for being evaluable for DLT will be counted in the Overall Number of Participants Analyzed.
Outcome measures
| Measure |
Nelarabine Dose Level 1
n=5 Participants
The study will begin at Dose Level 1 at 480 mg/m2 Nelarabine (75% of single agent maximum tolerated dose) and 330 mg/m2 Cyclophospamide and will escalate to the next Dose Level if the maximum tolerated dose (MTD) is not exceeded.
|
Nelarabine Dose Level 2
n=6 Participants
Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 330 mg/m2 Cyclophosphamide.
|
Nelarabine Dose Level 3
n=10 Participants
Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 400 mg/m2 Cyclophosphamide
|
Nelarabine Dose Level 0
Patients in this arm will be administered Nelarabine 325 mg/m2 (50% of single agent MTD) and 330 mg/2 Cyclophosphamide. Patients will only enter this arm if the MTD at Dose Level 1 has been exceeded. If the MTD is exceeded at Dose Level 0, the study will be closed.
|
|---|---|---|---|---|
|
To Determine the Presence of Dose-limiting Toxicities (DLTs) of Nelarabine, Etoposide and Cyclophosphamide When Given in Combination to Children With T-ALL and Bone Marrow Relapse or T-LL.
# of patients with DLT
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
To Determine the Presence of Dose-limiting Toxicities (DLTs) of Nelarabine, Etoposide and Cyclophosphamide When Given in Combination to Children With T-ALL and Bone Marrow Relapse or T-LL.
# of patients without DLT
|
5 Participants
|
5 Participants
|
8 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1-3 monthsPopulation: No patients met the criteria to be enrolled at Dose Level 0.
Patients will be evaluated at each dose level and for assessment of response to treatment. Not all patients enrolled at each dose level has been assessed to be evaluable for response. Only those that have met criteria for being evaluable for response will be counted in the Overall Number of Participants Analyzed.
Outcome measures
| Measure |
Nelarabine Dose Level 1
n=5 Participants
The study will begin at Dose Level 1 at 480 mg/m2 Nelarabine (75% of single agent maximum tolerated dose) and 330 mg/m2 Cyclophospamide and will escalate to the next Dose Level if the maximum tolerated dose (MTD) is not exceeded.
|
Nelarabine Dose Level 2
n=6 Participants
Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 330 mg/m2 Cyclophosphamide.
|
Nelarabine Dose Level 3
n=10 Participants
Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 400 mg/m2 Cyclophosphamide
|
Nelarabine Dose Level 0
Patients in this arm will be administered Nelarabine 325 mg/m2 (50% of single agent MTD) and 330 mg/2 Cyclophosphamide. Patients will only enter this arm if the MTD at Dose Level 1 has been exceeded. If the MTD is exceeded at Dose Level 0, the study will be closed.
|
|---|---|---|---|---|
|
To Determine the Complete Remission Rate After 1 and 2 Courses of This Therapy in Children With T-ALL and Bone Marrow Relapse or T-LL.
# of patients not with complete remission
|
3 Participants
|
4 Participants
|
9 Participants
|
0 Participants
|
|
To Determine the Complete Remission Rate After 1 and 2 Courses of This Therapy in Children With T-ALL and Bone Marrow Relapse or T-LL.
# of patients with complete remission
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Nelarabine Dose Level 1
Serious events: 1 serious events
Other events: 6 other events
Deaths: 4 deaths
Nelarabine Dose Level 2
Serious events: 5 serious events
Other events: 7 other events
Deaths: 7 deaths
Nelarabine Dose Level 3
Serious events: 7 serious events
Other events: 10 other events
Deaths: 8 deaths
Nelarabine Dose Level 0
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nelarabine Dose Level 1
n=6 participants at risk
The study will begin at Dose Level 1 at 480 mg/m2 Nelarabine (75% of single agent maximum tolerated dose) and 330 mg/m2 Cyclophospamide and will escalate to the next Dose Level if the maximum tolerated dose (MTD) is not exceeded. The first 3 patients will be enrolled into Dose Level 1.
|
Nelarabine Dose Level 2
n=7 participants at risk
Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 330 mg/m2 Cyclophosphamide.
|
Nelarabine Dose Level 3
n=10 participants at risk
Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 400 mg/m2 Cyclophosphamide
|
Nelarabine Dose Level 0
Patients in this arm will be administered Nelarabine 325 mg/m2 (50% of single agent MTD) and 330 mg/2 Cyclophosphamide. Patients will only enter this arm if the MTD at Dose Level 1 has been exceeded. If the MTD is exceeded at Dose Level 0, the study will be closed.
|
|---|---|---|---|---|
|
Cardiac disorders
HLH-Syndrome-Other
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
10.0%
1/10 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Nervous system disorders
Neuropathy- Peripheral Motor
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
20.0%
2/10 • Number of events 2 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Nervous system disorders
Neuropathy- Peripheral Sensory
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
10.0%
1/10 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Infection, Parainfluenza
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
10.0%
1/10 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
20.0%
2/10 • Number of events 2 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Herpes Zoster Infection
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
10.0%
1/10 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Oral Mucositis
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
10.0%
1/10 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Infection Oral cavity
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
10.0%
1/10 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
20.0%
2/10 • Number of events 2 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
40.0%
4/10 • Number of events 4 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Infection, vulva
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
10.0%
1/10 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Infection, perianal
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
20.0%
2/10 • Number of events 2 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
10.0%
1/10 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
catheter infection
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
10.0%
1/10 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Infection
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Hypoalbuminemia
|
16.7%
1/6 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
16.7%
1/6 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Endocrine disorders
hyponatremia
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Investigations
elevated bilirubin
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
GI bleed
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Immune system disorders
Sepsis
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
Other adverse events
| Measure |
Nelarabine Dose Level 1
n=6 participants at risk
The study will begin at Dose Level 1 at 480 mg/m2 Nelarabine (75% of single agent maximum tolerated dose) and 330 mg/m2 Cyclophospamide and will escalate to the next Dose Level if the maximum tolerated dose (MTD) is not exceeded. The first 3 patients will be enrolled into Dose Level 1.
|
Nelarabine Dose Level 2
n=7 participants at risk
Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 330 mg/m2 Cyclophosphamide.
|
Nelarabine Dose Level 3
n=10 participants at risk
Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 400 mg/m2 Cyclophosphamide
|
Nelarabine Dose Level 0
Patients in this arm will be administered Nelarabine 325 mg/m2 (50% of single agent MTD) and 330 mg/2 Cyclophosphamide. Patients will only enter this arm if the MTD at Dose Level 1 has been exceeded. If the MTD is exceeded at Dose Level 0, the study will be closed.
|
|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
20.0%
2/10 • Number of events 4 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Ear and labyrinth disorders
Epistaxis
|
16.7%
1/6 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
16.7%
1/6 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
42.9%
3/7 • Number of events 3 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
30.0%
3/10 • Number of events 3 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Hemoglobin
|
66.7%
4/6 • Number of events 4 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
42.9%
3/7 • Number of events 3 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
100.0%
10/10 • Number of events 10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
16.7%
1/6 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
20.0%
2/10 • Number of events 2 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Hypocalcemia
|
50.0%
3/6 • Number of events 3 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
10.0%
1/10 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Hypokalemia
|
50.0%
3/6 • Number of events 3 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
28.6%
2/7 • Number of events 2 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
30.0%
3/10 • Number of events 3 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Infection
|
16.7%
1/6 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
20.0%
2/10 • Number of events 3 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Leukopenia NOS
|
50.0%
3/6 • Number of events 3 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
71.4%
5/7 • Number of events 6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
50.0%
5/10 • Number of events 5 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, lower extremity
|
16.7%
1/6 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Neutrophil count
|
16.7%
1/6 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
85.7%
6/7 • Number of events 7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
40.0%
4/10 • Number of events 4 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
General disorders
Pain NOS
|
16.7%
1/6 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
10.0%
1/10 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Cardiac disorders
Pericardial effusion
|
16.7%
1/6 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
20.0%
2/10 • Number of events 2 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
16.7%
1/6 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Hyperuricemia
|
16.7%
1/6 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.7%
1/6 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
60.0%
6/10 • Number of events 8 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Psychiatric disorders
Anorexia
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
20.0%
2/10 • Number of events 2 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Investigations
aspartate aminotransferase increased
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
28.6%
2/7 • Number of events 2 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
10.0%
1/10 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Investigations
blood bilirubin increased
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
clostridial infection NOS
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
General disorders
constitutional symptoms
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
diarrhea NOS
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
28.6%
2/7 • Number of events 2 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
General disorders
Headache
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Hemorrhage, Upper GI NOS
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Nervous system disorders
hydrocephalus
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Hyperkalemia
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
28.6%
2/7 • Number of events 2 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Hypernatremia
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Hyponatremia
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
hypoxia
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
20.0%
2/10 • Number of events 2 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Infection, blood
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Influenza like illness
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Investigations
lipase increased
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Endocrine disorders
lymphopenia
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
57.1%
4/7 • Number of events 5 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
60.0%
6/10 • Number of events 6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Investigations
metabolic lab -other
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
General disorders
nausea
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
28.6%
2/7 • Number of events 2 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
10.0%
1/10 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
General disorders
Pain other
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
10.0%
1/10 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Nervous system disorders
peripheral sensory neuropathy
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
10.0%
1/10 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Platelet count decrease
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
85.7%
6/7 • Number of events 8 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
100.0%
10/10 • Number of events 11 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary hypertension NOS
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Pyrexia
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
sepsis
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
General disorders
vomiting
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
10.0%
1/10 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
14.3%
1/7 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/10 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
10.0%
1/10 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Immune system disorders
Allergy/Immunology- Other
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
10.0%
1/10 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Catheter-related infection
|
0.00%
0/6 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
0.00%
0/7 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
10.0%
1/10 • Number of events 1 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
—
0/0 • From date of first dose of Nelarabine, Etoposide, and Cyclophosphamide until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 66)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions
|
Additional Information
Clinical Research Coordinator, Consortia
Therapeutic Advancements of Childhood Leukemia and Lymphoma
Phone: 323-361-5312
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60