Safety and Tolerability of BL-8040 in Healthy Donors as Measured by Number and Grade of Adverse Events (Arm 1 Donors Only)
Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem Cells and Allogeneic Transplantation in Patients With Advanced Hematological Malignancies · Source last updated 2023-11-07
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 5 years
What was measured
-Adverse events will be graded according to the NCI CTCAE version 4.03
Analysis population: This outcome measure is for Donor Arm only.
Groups in this outcome
Arm 1: Donors
-Donors will receive subcutaneous (SC) BL-8040 in the morning (Day 1) followed by leukapheresis approximately 180 minutes (up to 270 minutes) after the injection per institutional protocol. If the donor does not reach the collection goal for mobilization (≥ 5.0 x 10\^6 CD34+ cells/kg), a second leukapheresis will be performed on Day 2 (24 hours ± 2 hours from the BL-8040 injection) in an effort to reach a total of ≥ 5 x 10\^6 CD34+ cells/kg and at least ≥ 2 x 10\^6 CD34+ cells/kg from the combined collections.
Arm 2: Recipients
-All or part of the leukapheresis product will be infused into the recipient per institutional guidelines. The day of the infusion will be considered Day 0; if the infusion occurs over multiple days, the final day of infusion will be considered Day 0
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Arm 1: Donors
25
Arm 2: Recipients
0
Reported measurements
Grade 1/2 anemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
17
Not reported
Not reported
Not reported
Not reported
Grade 1/2 sinus bradycardia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 sinus tachycardia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
2
Not reported
Not reported
Not reported
Not reported
Grade 1/2 eye pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 watering eyes
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 nausea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
5
Not reported
Not reported
Not reported
Not reported
Grade 1/2 oral dysesthesia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
6
Not reported
Not reported
Not reported
Not reported
Grade 1/2 vomiting
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
2
Not reported
Not reported
Not reported
Not reported
Grade 1/2 chills
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 fatigue
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
3
Not reported
Not reported
Not reported
Not reported
Grade 1/2 fever
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 infusion related reaction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 injection site reaction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
20
Not reported
Not reported
Not reported
Not reported
Grade 1/2 localized edema
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 vibration sensation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 allergic reaction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
20
Not reported
Not reported
Not reported
Not reported
Grade 1/2 papulopustular rash
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 bruising
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 hemoglobin increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
6
Not reported
Not reported
Not reported
Not reported
Grade 3 lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 lymphocyte count increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
22
Not reported
Not reported
Not reported
Not reported
Grade 1/2 platelet count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
22
Not reported
Not reported
Not reported
Not reported
Grade 1/2 weight loss
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 white blood cell decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
2
Not reported
Not reported
Not reported
Not reported
Grade 1/2 A1c increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 hyperglycemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
2
Not reported
Not reported
Not reported
Not reported
Grade 1/2 hyperkalemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 hypocalcemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
10
Not reported
Not reported
Not reported
Not reported
Grade 1/2 hypomagnesemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 arthralgia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 bone pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
2
Not reported
Not reported
Not reported
Not reported
Grade 1/2 foot pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 numbness in arms
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 pain in extremity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 dysesthesia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 dizziness
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 dysgeusia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 headache
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
3
Not reported
Not reported
Not reported
Not reported
Grade 1/2 paresthesia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
3
Not reported
Not reported
Not reported
Not reported
Grade 1/2 insomnia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 dyspnea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
1
Not reported
Not reported
Not reported
Not reported
Grade 1/2 hypertension
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
7
Not reported
Not reported
Not reported
Not reported
Grade 3 hypertension
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
4
Not reported
Not reported
Not reported
Not reported
Grade 1/2 hypotension
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm 1: Donors
2
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
17
title
Grade 1/2 anemia
categories
measurements
group Id
OG000
value
1
title
Grade 1/2 sinus bradycardia
categories
measurements
group Id
OG000
value
2
title
Grade 1/2 sinus tachycardia
categories
measurements
group Id
OG000
value
1
title
Grade 1/2 eye pain
categories
measurements
group Id
OG000
value
1
title
Grade 1/2 watering eyes
categories
measurements
group Id
OG000
value
5
title
Grade 1/2 nausea
categories
measurements
group Id
OG000
value
6
title
Grade 1/2 oral dysesthesia
categories
measurements
group Id
OG000
value
2
title
Grade 1/2 vomiting
categories
measurements
group Id
OG000
value
1
title
Grade 1/2 chills
categories
measurements
group Id
OG000
value
3
title
Grade 1/2 fatigue
categories
measurements
group Id
OG000
value
1
title
Grade 1/2 fever
categories
measurements
group Id
OG000
value
1
title
Grade 1/2 infusion related reaction
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
0
units
Participants
description
-Adverse events will be graded according to the NCI CTCAE version 4.03
groups
description
-Donors will receive subcutaneous (SC) BL-8040 in the morning (Day 1) followed by leukapheresis approximately 180 minutes (up to 270 minutes) after the injection per institutional protocol. If the donor does not reach the collection goal for mobilization (≥ 5.0 x 10\^6 CD34+ cells/kg), a second leukapheresis will be performed on Day 2 (24 hours ± 2 hours from the BL-8040 injection) in an effort to reach a total of ≥ 5 x 10\^6 CD34+ cells/kg and at least ≥ 2 x 10\^6 CD34+ cells/kg from the combined collections.
id
OG000
title
Arm 1: Donors
description
-All or part of the leukapheresis product will be infused into the recipient per institutional guidelines. The day of the infusion will be considered Day 0; if the infusion occurs over multiple days, the final day of infusion will be considered Day 0
id
OG001
title
Arm 2: Recipients
param Type
COUNT_OF_PARTICIPANTS
population Description
This outcome measure is for Donor Arm only.
reporting Status
POSTED
time Frame
Up to 5 years
title
Safety and Tolerability of BL-8040 in Healthy Donors as Measured by Number and Grade of Adverse Events (Arm 1 Donors Only)
Triangle