Trial Outcomes & Findings for T2007-002 Clofarabine, Etoposide, Cyclophosphamide in Relapsed Acute Myelogenous Leukemia (AML) (NCT NCT00939653)
NCT ID: NCT00939653
Last Updated: 2020-02-19
Results Overview
Disease response assessed after chemotherapy from bone marrow aspirates/biopsies and complete blood count.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Between Days 22-36 or on Day 43 and weekly thereafter if peripheral counts haven't recovered
Results posted on
2020-02-19
Participant Flow
Participant milestones
| Measure |
Single Arm - Protocol Chemo Regimen
All patients receive the same treatment regimen consisting of clofarabine, etoposide, cyclophosphamide, cytarabine, and filgrastim.
clofarabine: 40 mg/m2/day IV over 2 hours (given at hours 0 to 2) on days 1 through 5.
etoposide: 100 mg/m2/day IV over 2 hours (given at hours 2 to 4) on days 1 through 5.
cyclophosphamide: 440 mg/m2/day IV as a 30-60 minute infusion (given at hours 4 to 5) on days 1 through 5.
filgrastim: 5 micrograms/kg/day IV or SC will begin on Day 6 and end when the ANC is \> 1000 x 2 days.
cytarabine: Given intrathecally on day 1 at the dose defined by age below. 30 mg for patients age 1-1.99 50 mg for patients age 2-2.99 70 mg for patients \>3 years of age
|
|---|---|
|
Treatment Course 1
STARTED
|
6
|
|
Treatment Course 1
COMPLETED
|
6
|
|
Treatment Course 1
NOT COMPLETED
|
0
|
|
Treatment Course 2
STARTED
|
2
|
|
Treatment Course 2
COMPLETED
|
2
|
|
Treatment Course 2
NOT COMPLETED
|
0
|
|
Treatment Course 3
STARTED
|
0
|
|
Treatment Course 3
COMPLETED
|
0
|
|
Treatment Course 3
NOT COMPLETED
|
0
|
|
Treatment Course 4
STARTED
|
0
|
|
Treatment Course 4
COMPLETED
|
0
|
|
Treatment Course 4
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
T2007-002 Clofarabine, Etoposide, Cyclophosphamide in Relapsed Acute Myelogenous Leukemia (AML)
Baseline characteristics by cohort
| Measure |
Enrolled Patients
n=6 Participants
Baseline measures were collected for all enrolled patients.
|
|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Between Days 22-36 or on Day 43 and weekly thereafter if peripheral counts haven't recoveredPopulation: Patients that completed at least 1 treatment course of study drug.
Disease response assessed after chemotherapy from bone marrow aspirates/biopsies and complete blood count.
Outcome measures
| Measure |
Enrolled Patients
n=6 Participants
All patient that completed at least 1 treatment course.
|
|---|---|
|
Achievement of Complete Remission (CR) at Reinduction
|
1 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study therapy until 30 days after last therapy doseNumber of participants who died.
Outcome measures
| Measure |
Enrolled Patients
n=6 Participants
All patient that completed at least 1 treatment course.
|
|---|---|
|
Death
|
4 Participants
|
Adverse Events
Enrolled Patients
Serious events: 6 serious events
Other events: 6 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Enrolled Patients
n=6 participants at risk
All patients enrolled onto study.
|
|---|---|
|
Vascular disorders
Capillary leak syndrome
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Renal and urinary disorders
Renal failure NOS
|
33.3%
2/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
50.0%
3/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
2/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Infections and infestations
Grade 3 Infection (blood)
|
33.3%
2/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Vascular disorders
Hypotension NOS
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Blood and lymphatic system disorders
Neutrophil Count
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Vascular disorders
Hypertension NOS
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
General disorders
Multi-organ failure
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Infections and infestations
Clostridial infection NOS
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Infections and infestations
Grade 4 Infection
|
33.3%
2/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Infections and infestations
Grade 4 ANC
|
33.3%
2/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
Other adverse events
| Measure |
Enrolled Patients
n=6 participants at risk
All patients enrolled onto study.
|
|---|---|
|
Investigations
aPTT prolonged
|
33.3%
2/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
3/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Investigations
AST increased
|
50.0%
3/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Investigations
Blood amylase increased
|
33.3%
2/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Investigations
Blood bilirubin increased
|
33.3%
2/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow-Other
|
33.3%
2/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative NOS
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Cardiac disorders
Electrocardiogram QT prolonged
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Vascular disorders
Epistaxis
|
33.3%
2/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Investigations
GGT increased
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Vascular disorders
Hematoma
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Blood and lymphatic system disorders
Hemoglobin - low
|
66.7%
4/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Vascular disorders
Hemorrhagic stroke
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Metabolism and nutrition disorders
Hyperglycemia NOS
|
33.3%
2/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Vascular disorders
Hypertension NOS
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
4/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
2/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Metabolism and nutrition disorders
Hypoglycemia NOS
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
83.3%
5/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
2/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
66.7%
4/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Vascular disorders
Hypotension NOS
|
33.3%
2/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Infections and infestations
Infection w/ Gr 3/4 ANC
|
83.3%
5/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Infections and infestations
Infection w/ norm ANC, Blood
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Infections and infestations
Infection w/ unk ANC, Mucosa
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Cardiac disorders
Left ventricular failure
|
33.3%
2/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Blood and lymphatic system disorders
Leukopenia NOS
|
83.3%
5/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Vascular disorders
Mouth hemorrhage
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Blood and lymphatic system disorders
Neutrophil count
|
50.0%
3/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
General disorders
Pain - other
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
83.3%
5/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
50.0%
3/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Psychiatric disorders
Psychosis aggravated
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
2/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Skin and subcutaneous tissue disorders
Urticaria NOS
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
|
Gastrointestinal disorders
Vomiting NOS
|
16.7%
1/6 • From the time of treatment start until 30 days after the last dose of protocol therapy. Specific period of time varies depending on # of courses and conditions for starting next course; collection timeframe is roughly between Days 0 and Day 150.
The definition of adverse event and SAE used for data collection does not differ from that in the clinicaltrials.gov Definitions. Patients were evaluated regularly by the treating physician.
|
Additional Information
Peggy Romano, BA, CCRP
Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) / Children's Hospital Los Angeles
Phone: 323-361-5505
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60