Trial Outcomes & Findings for Intravenous AMD3100 for Collection of Autologous Peripheral Blood Stem Cells in Patients With Lymphoma (NCT NCT00733824)
NCT ID: NCT00733824
Last Updated: 2017-03-09
Results Overview
* MTD: the highest dose level of AMD3100 at which ≤ 1 of 6 participants experience a dose limiting toxicity (DLT). The MTD will be the Phase II dose. * DLT: selected grade III or higher (hematologic, cardiac, pulmonary, hepatobiliary/pancreatic, renal, or CNS) not attributable to any other cause.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
61 participants
Primary outcome timeframe
7 days from first dose of IV AMD3100
Results posted on
2017-03-09
Participant Flow
Participant milestones
| Measure |
Phase I - Cohort 1
* 240 µg/kg SC AMD3100 Day -5
* 10 µg/kg SC G-CSF Day -4 thru Day -1
* 160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
* Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Phase I - Cohort 2
* 240 µg/kg SC AMD3100 Day -5
* 10 µg/kg SC G-CSF Day -4 thru Day -1
* 240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
* Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Phase I - Cohort 3
* 240 µg/kg SC AMD3100 Day -5
* 10 µg/kg SC G-CSF Day -4 thru Day -1
* 320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
* Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Phase I - Cohort 4
240 µg/kg SC AMD3100 Day -5 10 µg/kg SC G-CSF Day -4 thru Day -1 400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1 Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Phase II
* 240 µg/kg SC AMD3100 Day -5
* 10 µg/kg SC G-CSF Day -4 thru Day -1
* MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1
* Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
|---|---|---|---|---|---|
|
Phase I
STARTED
|
10
|
3
|
6
|
6
|
0
|
|
Phase I
COMPLETED
|
9
|
3
|
6
|
6
|
0
|
|
Phase I
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
|
Phase II
STARTED
|
0
|
0
|
0
|
0
|
36
|
|
Phase II
COMPLETED
|
0
|
0
|
0
|
0
|
36
|
|
Phase II
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase I - Cohort 1
* 240 µg/kg SC AMD3100 Day -5
* 10 µg/kg SC G-CSF Day -4 thru Day -1
* 160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
* Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Phase I - Cohort 2
* 240 µg/kg SC AMD3100 Day -5
* 10 µg/kg SC G-CSF Day -4 thru Day -1
* 240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
* Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Phase I - Cohort 3
* 240 µg/kg SC AMD3100 Day -5
* 10 µg/kg SC G-CSF Day -4 thru Day -1
* 320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
* Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Phase I - Cohort 4
240 µg/kg SC AMD3100 Day -5 10 µg/kg SC G-CSF Day -4 thru Day -1 400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1 Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Phase II
* 240 µg/kg SC AMD3100 Day -5
* 10 µg/kg SC G-CSF Day -4 thru Day -1
* MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1
* Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
|---|---|---|---|---|---|
|
Phase I
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Intravenous AMD3100 for Collection of Autologous Peripheral Blood Stem Cells in Patients With Lymphoma
Baseline characteristics by cohort
| Measure |
Cohort 1
n=10 Participants
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Cohort 2
n=3 Participants
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Cohort 3
n=6 Participants
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Cohort 4
n=6 Participants
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Phase II
n=36 Participants
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.5 years
n=5 Participants
|
48 years
n=7 Participants
|
50 years
n=5 Participants
|
47 years
n=4 Participants
|
60 years
n=21 Participants
|
53 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
41 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
36 participants
n=21 Participants
|
61 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 7 days from first dose of IV AMD3100* MTD: the highest dose level of AMD3100 at which ≤ 1 of 6 participants experience a dose limiting toxicity (DLT). The MTD will be the Phase II dose. * DLT: selected grade III or higher (hematologic, cardiac, pulmonary, hepatobiliary/pancreatic, renal, or CNS) not attributable to any other cause.
Outcome measures
| Measure |
Phase 1 (Dose Levels 1-4)
n=25 Participants
|
Cohort 2
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Cohort 3
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Cohort 4
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Phase II
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
AMD3100
G-CSF
Apheresis
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of IV AMD3100 + G-CSF in Mobilization of Peripheral Blood Stem Cell in Patients With Lymphoma (Phase I Only)
|
400 micrograms/kilograms
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 days from first dose of IV AMD3100Dose limiting toxicity: selected grade III or higher (hematologic, cardiac, pulmonary, hepatobiliary/pancreatic, renal, or CNS) not attributable to any other cause.
Outcome measures
| Measure |
Phase 1 (Dose Levels 1-4)
n=10 Participants
|
Cohort 2
n=3 Participants
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Cohort 3
n=6 Participants
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Cohort 4
n=6 Participants
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Phase II
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
AMD3100
G-CSF
Apheresis
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced Dose Limiting Toxicities in Phase I Portion of Study
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: From baseline to Day 1Outcome measures
| Measure |
Phase 1 (Dose Levels 1-4)
n=61 Participants
|
Cohort 2
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Cohort 3
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Cohort 4
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Phase II
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
AMD3100
G-CSF
Apheresis
|
|---|---|---|---|---|---|
|
Kinetics of Stem Cell Mobilization Using IV AMD3100 as Measured by Median Fold Change in the Number of CD34+ Cells After AMD3100 IV Administration
|
2.1 fold change
Interval 0.8 to 7.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Phase 1 (Dose Levels 1-4)
n=25 Participants
|
Cohort 2
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Cohort 3
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Cohort 4
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Phase II
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
AMD3100
G-CSF
Apheresis
|
|---|---|---|---|---|---|
|
Pharmacodynamic Response to a Dose of SC AMD3100 as Measured by Mean Percentage of the Circulating CD34+ Count With the 34+RA-123+/- Phenotype
|
49.0 mean percentage of total CD34+ cells
Standard Deviation 13.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days post transplantOutcome measures
| Measure |
Phase 1 (Dose Levels 1-4)
n=10 Participants
|
Cohort 2
n=3 Participants
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Cohort 3
n=6 Participants
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Cohort 4
n=6 Participants
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Phase II
n=36 Participants
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
AMD3100
G-CSF
Apheresis
|
|---|---|---|---|---|---|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Neutrophils (ANC)
|
3 participants
|
3 participants
|
6 participants
|
6 participants
|
29 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Hemoglobin
|
3 participants
|
2 participants
|
4 participants
|
4 participants
|
20 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Leukocytes (WBC)
|
4 participants
|
3 participants
|
6 participants
|
6 participants
|
32 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Lymphopenia
|
3 participants
|
3 participants
|
3 participants
|
5 participants
|
29 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Platelets
|
5 participants
|
3 participants
|
5 participants
|
6 participants
|
34 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Alkaline phosphtase
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
SGPT (ALT)
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Hypoxia
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Hypotension
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Mucositis
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Infection with neutropenia
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Febrile neutropenia
|
0 participants
|
0 participants
|
0 participants
|
4 participants
|
0 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
INR
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
PTT
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
8 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Bleeding at catheter site
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Hemorrhage - spleen
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Atrial fibrillation
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Diarrhea
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Ileus
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Nausea
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Vomiting
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Hyperbilirubinemia
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Fungal infection
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Opportunistic infection
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Clostridium difficile
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Colitis
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
E. coli infection
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Leptotrichia
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Lung infection (pneumonia)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Staph infection
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Typhlitis
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Glucose - high
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Magnesium - high
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Potassium - low
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Sodium - low
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
6 participants
|
|
Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event
Cough
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
Cohort 1
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase II
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=10 participants at risk
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Cohort 2
n=3 participants at risk
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Cohort 3
n=6 participants at risk
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Cohort 4
n=6 participants at risk
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Phase II
n=36 participants at risk
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
General disorders
Death - disease progression
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
General disorders
Hemorrhage - spleen
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.0%
1/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/36
|
Other adverse events
| Measure |
Cohort 1
n=10 participants at risk
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Cohort 2
n=3 participants at risk
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Cohort 3
n=6 participants at risk
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Cohort 4
n=6 participants at risk
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Phase II
n=36 participants at risk
240 µg/kg SC AMD3100 Day -5
10 µg/kg SC G-CSF Day -4 thru Day -1
MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1
Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
80.0%
8/10
|
0.00%
0/3
|
16.7%
1/6
|
100.0%
6/6
|
50.0%
18/36
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/6
|
19.4%
7/36
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/6
|
5.6%
2/36
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6
|
2.8%
1/36
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
30.0%
3/10
|
33.3%
1/3
|
0.00%
0/6
|
33.3%
2/6
|
38.9%
14/36
|
|
Metabolism and nutrition disorders
Calcium (high)
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
5.6%
2/36
|
|
Metabolism and nutrition disorders
Calcium - low
|
20.0%
2/10
|
0.00%
0/3
|
16.7%
1/6
|
100.0%
6/6
|
11.1%
4/36
|
|
Injury, poisoning and procedural complications
Catheter site - neck pain
|
30.0%
3/10
|
33.3%
1/3
|
16.7%
1/6
|
16.7%
1/6
|
11.1%
4/36
|
|
Cardiac disorders
Chest (tightness, pressure)
|
0.00%
0/10
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/36
|
|
Infections and infestations
Clostridium difficile
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Infections and infestations
Colitis
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
0.00%
0/10
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/36
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
3/10
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6
|
2.8%
1/36
|
|
Investigations
Creatinine
|
10.0%
1/10
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/36
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
General disorders
Diaphoresis
|
10.0%
1/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Gastrointestinal disorders
Abdominal distension/bloating
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
5.6%
2/36
|
|
Gastrointestinal disorders
Abdominal pain
|
60.0%
6/10
|
66.7%
2/3
|
33.3%
2/6
|
33.3%
2/6
|
8.3%
3/36
|
|
Metabolism and nutrition disorders
Albumin - low
|
20.0%
2/10
|
0.00%
0/3
|
0.00%
0/6
|
50.0%
3/6
|
5.6%
2/36
|
|
Investigations
Alkaline phosphatase
|
70.0%
7/10
|
33.3%
1/3
|
83.3%
5/6
|
100.0%
6/6
|
72.2%
26/36
|
|
Immune system disorders
Allergic reaction (platelets)
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
20.0%
2/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
10.0%
1/10
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6
|
2.8%
1/36
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint)
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
2/6
|
19.4%
7/36
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
5.6%
2/36
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.0%
3/10
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/6
|
19.4%
7/36
|
|
Injury, poisoning and procedural complications
Bleeding at catheter site
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Eye disorders
Blurred vision
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
2/6
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.0%
3/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Infections and infestations
E. coli infection
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
General disorders
Edema
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
13.9%
5/36
|
|
General disorders
Fatigue
|
80.0%
8/10
|
100.0%
3/3
|
33.3%
2/6
|
83.3%
5/6
|
22.2%
8/36
|
|
Infections and infestations
Febrile neutropenia
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
66.7%
4/6
|
0.00%
0/36
|
|
General disorders
Fever
|
10.0%
1/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/36
|
|
General disorders
Flu-like syndrome
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Vascular disorders
Flushing
|
0.00%
0/10
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/6
|
5.6%
2/36
|
|
Infections and infestations
Fungal infection
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
General disorders
General body ache
|
0.00%
0/10
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/36
|
|
Metabolism and nutrition disorders
Glucose - high
|
40.0%
4/10
|
0.00%
0/3
|
0.00%
0/6
|
50.0%
3/6
|
8.3%
3/36
|
|
Metabolism and nutrition disorders
Glucose - low
|
10.0%
1/10
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/36
|
|
General disorders
HSV blister - lip
|
10.0%
1/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/36
|
|
Nervous system disorders
Headache
|
50.0%
5/10
|
0.00%
0/3
|
16.7%
1/6
|
16.7%
1/6
|
11.1%
4/36
|
|
Vascular disorders
Hematoma
|
10.0%
1/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/36
|
|
Blood and lymphatic system disorders
Hemoglobin
|
90.0%
9/10
|
66.7%
2/3
|
100.0%
6/6
|
100.0%
6/6
|
75.0%
27/36
|
|
Vascular disorders
Hot flashes
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Investigations
Hyperbilirubinemia
|
10.0%
1/10
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6
|
8.3%
3/36
|
|
Gastrointestinal disorders
Hypersalivation
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Vascular disorders
Hypotension
|
20.0%
2/10
|
33.3%
1/3
|
0.00%
0/6
|
83.3%
5/6
|
8.3%
3/36
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
30.0%
3/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/36
|
|
Investigations
INR
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
50.0%
3/6
|
8.3%
3/36
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Infections and infestations
Infection with neutropenia
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
2/6
|
0.00%
0/36
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/36
|
|
Skin and subcutaneous tissue disorders
Itching
|
10.0%
1/10
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.00%
0/10
|
0.00%
0/3
|
33.3%
2/6
|
0.00%
0/6
|
0.00%
0/36
|
|
Infections and infestations
Leptotrichia infection
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Investigations
Leukocytes (WBC)
|
60.0%
6/10
|
100.0%
3/3
|
100.0%
6/6
|
100.0%
6/6
|
91.7%
33/36
|
|
Infections and infestations
Lung infection (pneumonia)
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Investigations
Lymphopenia
|
60.0%
6/10
|
100.0%
3/3
|
50.0%
3/6
|
83.3%
5/6
|
86.1%
31/36
|
|
Metabolism and nutrition disorders
Magnesium (high)
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Metabolism and nutrition disorders
Magnesium - low
|
20.0%
2/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Gastrointestinal disorders
Mucositis
|
50.0%
5/10
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
Muscle cramping
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
20.0%
2/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
5.6%
2/36
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - left arm
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/36
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10
|
0.00%
0/3
|
66.7%
4/6
|
66.7%
4/6
|
36.1%
13/36
|
|
Investigations
Neutrophils (ANC)
|
30.0%
3/10
|
100.0%
3/3
|
100.0%
6/6
|
100.0%
6/6
|
80.6%
29/36
|
|
Endocrine disorders
Night sweats
|
10.0%
1/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/36
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Infections and infestations
Opportunistic infection w/grade 2 or higher lymphopenia
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Investigations
PTT
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
66.7%
4/6
|
41.7%
15/36
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Investigations
Platelets
|
70.0%
7/10
|
0.00%
0/3
|
83.3%
5/6
|
100.0%
6/6
|
97.2%
35/36
|
|
Metabolism and nutrition disorders
Potassium - low
|
30.0%
3/10
|
0.00%
0/3
|
0.00%
0/6
|
66.7%
4/6
|
5.6%
2/36
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6
|
8.3%
3/36
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.0%
3/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/36
|
|
General disorders
Rigors/chills
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Investigations
SGOT (AST)
|
30.0%
3/10
|
0.00%
0/3
|
16.7%
1/6
|
66.7%
4/6
|
16.7%
6/36
|
|
Investigations
SGPT (ALT)
|
60.0%
6/10
|
0.00%
0/3
|
33.3%
2/6
|
83.3%
5/6
|
13.9%
5/36
|
|
Nervous system disorders
Sensory neuropathy
|
0.00%
0/10
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/6
|
44.4%
16/36
|
|
Infections and infestations
Sinus infection
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Cardiac disorders
Sinus tachycardia
|
30.0%
3/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/36
|
|
Metabolism and nutrition disorders
Sodium - low
|
10.0%
1/10
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
2/6
|
16.7%
6/36
|
|
Infections and infestations
Staph infection
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Nervous system disorders
Tremor
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/36
|
|
Infections and infestations
Typhlitis
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Metabolism and nutrition disorders
Uric acid (high)
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
2.8%
1/36
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
10.0%
1/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/36
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
5/10
|
0.00%
0/3
|
16.7%
1/6
|
33.3%
2/6
|
13.9%
5/36
|
|
Investigations
Weight gain
|
10.0%
1/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/36
|
|
Investigations
Weight loss
|
10.0%
1/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/36
|
|
General disorders
Whole body pain
|
0.00%
0/10
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
3/36
|
Additional Information
Amanda F. Cashen, M.D.
Washington University School of Medicine
Phone: 314-454-8304
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place