Trial Outcomes & Findings for Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma (NCT NCT01977677)
NCT ID: NCT01977677
Last Updated: 2018-10-23
Results Overview
Dose Limiting Toxicity is defined as defined as any hematologic or on-hematologic adverse events grade 3 or higher using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 with a suspected causal relationship to Plerixafor (including electrocardiogram changes indicative of ischemia, ventricular tachycardia)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to 30 days post plerixafor
Results posted on
2018-10-23
Participant Flow
A total of 30 patients were enrolled at one study center.
A total of 32 subjects were screened. One was a screen failure, one withdrew consent prior to initiating the infusion. Twenty-nine subjects enrolled and completed the 28 day Plerixafor infusion. One subject enrolled but did not complete the infusion due to an unrelated adverse event.
Participant milestones
| Measure |
Escalation: Plerixafor 200 mcg/kg/Day
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 200 mcg/kg/day over 4 weeks.
|
Escalation: Plerixafor 400 mcg/kg/Day
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
|
Expansion: Plerixafor 400 mcg/kg/Day
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
21
|
|
Overall Study
COMPLETED
|
3
|
6
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Escalation: Plerixafor 200 mcg/kg/Day
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 200 mcg/kg/day over 4 weeks.
|
Escalation: Plerixafor 400 mcg/kg/Day
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
|
Expansion: Plerixafor 400 mcg/kg/Day
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
|
|---|---|---|---|
|
Overall Study
Unrelated Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma
Baseline characteristics by cohort
| Measure |
Escalation: Plerixafor 200 mcg/kg/Day
n=3 Participants
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 200 mcg/kg/day over 4 weeks.
|
Escalation: Plerixafor 400 mcg/kg/Day
n=6 Participants
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
|
Expansion: Plerixafor 400 mcg/kg/Day
n=20 Participants
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Age, Continuous
|
64 years
n=99 Participants
|
62 years
n=107 Participants
|
60 years
n=206 Participants
|
60 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
6 participants
n=107 Participants
|
20 participants
n=206 Participants
|
29 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days post plerixaforDose Limiting Toxicity is defined as defined as any hematologic or on-hematologic adverse events grade 3 or higher using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 with a suspected causal relationship to Plerixafor (including electrocardiogram changes indicative of ischemia, ventricular tachycardia)
Outcome measures
| Measure |
Escalation: Plerixafor 200 mcg/kg/Day
n=3 Participants
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 200 mcg/kg/day over 4 weeks.
|
Escalation: Plerixafor 400 mcg/kg/Day
n=6 Participants
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
|
Expansion: Plerixafor 400 mcg/kg/Day
n=21 Participants
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
|
|---|---|---|---|
|
Dose-limiting Toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 months from start of irradiationProgression free survival based on the Response Assessment for Neuro-Oncology (RANO) criteria, using both clinical examinations and MRIs with and without contrast summarized with Kaplan Meier estimates.
Outcome measures
| Measure |
Escalation: Plerixafor 200 mcg/kg/Day
n=3 Participants
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 200 mcg/kg/day over 4 weeks.
|
Escalation: Plerixafor 400 mcg/kg/Day
n=6 Participants
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
|
Expansion: Plerixafor 400 mcg/kg/Day
n=20 Participants
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
|
|---|---|---|---|
|
Participants Alive and Without Disease Progression At 6 Months After the Start of the Irradiation
|
3 Participants
|
5 Participants
|
19 Participants
|
Adverse Events
Escalation: Plerixafor 200 mcg/kg/Day
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Escalation: Plerixafor 400 mcg/kg/Day
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Expansion: Plerixafor 400 mcg/kg/Day
Serious events: 3 serious events
Other events: 21 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Escalation: Plerixafor 200 mcg/kg/Day
n=3 participants at risk
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 200 mcg/kg/day over 4 weeks.
|
Escalation: Plerixafor 400 mcg/kg/Day
n=6 participants at risk
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
|
Expansion: Plerixafor 400 mcg/kg/Day
n=21 participants at risk
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease Progression
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pseudoprogression
|
33.3%
1/3 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/21 • Up to 30 days after Plerixafor Infusion
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hemorrhagic hepatic cyst
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
Other adverse events
| Measure |
Escalation: Plerixafor 200 mcg/kg/Day
n=3 participants at risk
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 200 mcg/kg/day over 4 weeks.
|
Escalation: Plerixafor 400 mcg/kg/Day
n=6 participants at risk
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
|
Expansion: Plerixafor 400 mcg/kg/Day
n=21 participants at risk
One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.
|
|---|---|---|---|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Psychiatric disorders
Bad dreams
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
16.7%
1/6 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
28.6%
6/21 • Number of events 6 • Up to 30 days after Plerixafor Infusion
|
|
General disorders
Gait Disturbance
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
9.5%
2/21 • Number of events 2 • Up to 30 days after Plerixafor Infusion
|
|
General disorders
Pain
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
9.5%
2/21 • Number of events 2 • Up to 30 days after Plerixafor Infusion
|
|
General disorders
Fever
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
General disorders
Localized Edema
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Vascular disorders
Hot Flashes
|
33.3%
1/3 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
33.3%
2/6 • Number of events 2 • Up to 30 days after Plerixafor Infusion
|
23.8%
5/21 • Number of events 5 • Up to 30 days after Plerixafor Infusion
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/21 • Up to 30 days after Plerixafor Infusion
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
16.7%
1/6 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
9.5%
2/21 • Number of events 2 • Up to 30 days after Plerixafor Infusion
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 2 • Up to 30 days after Plerixafor Infusion
|
33.3%
2/6 • Number of events 2 • Up to 30 days after Plerixafor Infusion
|
14.3%
3/21 • Number of events 3 • Up to 30 days after Plerixafor Infusion
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
50.0%
3/6 • Number of events 3 • Up to 30 days after Plerixafor Infusion
|
14.3%
3/21 • Number of events 3 • Up to 30 days after Plerixafor Infusion
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
16.7%
1/6 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
16.7%
1/6 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/21 • Up to 30 days after Plerixafor Infusion
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
16.7%
1/6 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
9.5%
2/21 • Number of events 2 • Up to 30 days after Plerixafor Infusion
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
16.7%
1/6 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/21 • Up to 30 days after Plerixafor Infusion
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
33.3%
2/6 • Number of events 2 • Up to 30 days after Plerixafor Infusion
|
19.0%
4/21 • Number of events 4 • Up to 30 days after Plerixafor Infusion
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
19.0%
4/21 • Number of events 4 • Up to 30 days after Plerixafor Infusion
|
|
Nervous system disorders
Parasthesia
|
33.3%
1/3 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
16.7%
1/6 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/21 • Up to 30 days after Plerixafor Infusion
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
9.5%
2/21 • Number of events 2 • Up to 30 days after Plerixafor Infusion
|
|
Nervous system disorders
Cognitive Disturbance
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Nervous system disorders
Facial Muscle Weakness
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
66.7%
4/6 • Number of events 4 • Up to 30 days after Plerixafor Infusion
|
33.3%
7/21 • Number of events 7 • Up to 30 days after Plerixafor Infusion
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
16.7%
1/6 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/21 • Up to 30 days after Plerixafor Infusion
|
|
Investigations
Cardiac Troponin 1 increased
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Investigations
INR increased
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Skin and subcutaneous tissue disorders
wart like growth
|
33.3%
1/3 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/21 • Up to 30 days after Plerixafor Infusion
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
16.7%
1/6 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Skin and subcutaneous tissue disorders
Bullous Dermatitis
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Eye disorders
Conjunctivitis
|
33.3%
1/3 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
50.0%
3/6 • Number of events 3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/21 • Up to 30 days after Plerixafor Infusion
|
|
Eye disorders
Dry Eyes
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Eye disorders
Eye Pain
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
16.7%
1/6 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/21 • Up to 30 days after Plerixafor Infusion
|
|
Eye disorders
Floaters
|
33.3%
1/3 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/21 • Up to 30 days after Plerixafor Infusion
|
|
Eye disorders
Watering Eyes
|
33.3%
1/3 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/21 • Up to 30 days after Plerixafor Infusion
|
|
Infections and infestations
Bone infection
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Infections and infestations
Thrush
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Infections and infestations
Skin Infection
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
16.7%
1/6 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/21 • Up to 30 days after Plerixafor Infusion
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
9.5%
2/21 • Number of events 2 • Up to 30 days after Plerixafor Infusion
|
|
Immune system disorders
Allergic Reaction
|
33.3%
1/3 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
16.7%
1/6 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/21 • Up to 30 days after Plerixafor Infusion
|
|
Immune system disorders
Enhanced immune response
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
16.7%
1/6 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/21 • Up to 30 days after Plerixafor Infusion
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
33.3%
1/3 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/21 • Up to 30 days after Plerixafor Infusion
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
16.7%
1/6 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/21 • Up to 30 days after Plerixafor Infusion
|
|
Respiratory, thoracic and mediastinal disorders
allergic Rhinitis
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
16.7%
1/6 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/21 • Up to 30 days after Plerixafor Infusion
|
|
Skin and subcutaneous tissue disorders
Allergic dermatitis
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
|
Skin and subcutaneous tissue disorders
Rash Spots on head
|
0.00%
0/3 • Up to 30 days after Plerixafor Infusion
|
0.00%
0/6 • Up to 30 days after Plerixafor Infusion
|
4.8%
1/21 • Number of events 1 • Up to 30 days after Plerixafor Infusion
|
Additional Information
Lawrence Recht, MD, Professor of Neurology
Stanford University School of Medicine
Phone: 650-725-8630
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60