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Safety and Efficacy of BL-8040 for the Mobilization of Donor Hematopoietic Stem Cells and Allogeneic Transplantation in Patients With Advanced Hematological Malignancies

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ClinicalTrials.gov Identifier: NCT02639559
Recruitment Status : Active, not recruiting
First Posted : December 24, 2015
Results First Posted : May 1, 2019
Last Update Posted : April 8, 2021
Sponsor:
Collaborator:
BioLineRx, Ltd.
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia
Non-Hodgkin's Lymphoma
Non-Hodgkin Lymphoma
Hodgkin Disease
Hodgkins Disease
Hodgkin's Disease
Multiple Myeloma
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Interventions Drug: BL-8040
Procedure: Leukapheresis
Procedure: Hematopoietic cell transplant
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: Donors Arm 2: Recipients
Hide Arm/Group 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. -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
Period Title: Overall Study
Started 25 25
Completed 24 22
Not Completed 1 3
Reason Not Completed
Mobilization failure             0             3
Issues with vascular acess             1             0
Arm/Group Title Arm 1: Donors Arm 2: Recipients Total
Hide Arm/Group 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. -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 Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
55
(20 to 69)
58
(26 to 71)
55
(20 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
7
  28.0%
10
  40.0%
17
  34.0%
Male
18
  72.0%
15
  60.0%
33
  66.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Hispanic or Latino
2
   8.0%
2
   8.0%
4
   8.0%
Not Hispanic or Latino
21
  84.0%
23
  92.0%
44
  88.0%
Unknown or Not Reported
2
   8.0%
0
   0.0%
2
   4.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   4.0%
1
   4.0%
2
   4.0%
White
20
  80.0%
22
  88.0%
42
  84.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
  16.0%
2
   8.0%
6
  12.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Number of Donors That Mobilize ≥ 2 x 10^6 CD34+ Cells/kg of Recipients Weight After a Single Injection of BL-8040 After no More Than Two Leukapheresis Collections (Arm 1 - Donors Only)
Hide Description [Not Specified]
Time Frame Up to Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure is for Arm 1 - Donors only.
Arm/Group Title Arm 1: Donors Arm 2: Recipients
Hide Arm/Group 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.
-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
Overall Number of Participants Analyzed 24 0
Measure Type: Count of Participants
Unit of Measure: Participants
22
  91.7%
2.Secondary Outcome
Title Safety and Tolerability of BL-8040 in Healthy Donors as Measured by Number and Grade of Adverse Events (Arm 1 Donors Only)
Hide Description -Adverse events will be graded according to the NCI CTCAE version 4.03
Time Frame Up to 5 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Time to Neutrophil Engraftment Post-transplant in Patients Undergoing Allogeneic Stem Cell Transplant (Arm 2 Recipients Only)
Hide Description -Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/μL following conditioning regimen induced nadir.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
-Donors are not evaluable for this outcome measure.
Arm/Group Title Arm 1: Donors Arm 2: Recipients
Hide Arm/Group 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.
-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
Overall Number of Participants Analyzed 0 22
Median (Full Range)
Unit of Measure: days
13
(11 to 26)
4.Secondary Outcome
Title Time to Platelet Engraftment Post-transplant in Patients Undergoing Allogeneic Stem Cell Transplant (Arm 2 Recipients Only)
Hide Description -Time to platelet engraftment is measured by determining the first of 3 consecutive measurements of platelet count ≥ 20,000/μL without platelet transfusion support for 7 days.
Time Frame Through 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
-Donors are not evaluable for this outcome measure. 1 recipient was not evaluable due to now platelet nadir and 1 recipient was not evaluable due to no engraftment.
Arm/Group Title Arm 1: Donors Arm 2: Recipients
Hide Arm/Group 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.
-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
Overall Number of Participants Analyzed 0 20
Median (Full Range)
Unit of Measure: days
20
(15 to 41)
5.Secondary Outcome
Title Number of Recipients With Primary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With BL-8040 (Arm 2 Recipients Only)
Hide Description [Not Specified]
Time Frame Up to 1 year after transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
-Donors are not evaluable for this outcome measure.
Arm/Group Title Arm 1: Donors Arm 2: Recipients
Hide Arm/Group 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.
-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
Overall Number of Participants Analyzed 0 22
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
6.Secondary Outcome
Title Incidence of Secondary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With BL-8040 (Arm 2 Recipients Only)
Hide Description [Not Specified]
Time Frame Up to 1 year after transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
-Donors are not evaluable for this outcome measure.
Arm/Group Title Arm 1: Donors Arm 2: Recipients
Hide Arm/Group 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.
-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
Overall Number of Participants Analyzed 0 22
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
7.Secondary Outcome
Title Cumulative Incidence of Grade 2-4 Acute Graft Versus Host Disease (GvHD) as Measured by Minnesota Acute GVHD Criteria (Arm 2 Recipients Only)
Hide Description
  • Acute GVHD rate and worst severity is noted
  • 4 organ categories (skin, liver, lower GI, and upper GI)
  • Skin: Grade I: 1-2 , Grade II: 3, Grade III: N/A, Grade IV: 4
  • Liver: Grade I: 0, Grade II: 1, Grade III: 2-4, Grade IV: N/A
  • Lower GI: Grade I: 0, Grade II: 1: Grade II: 2-3: Grade IV: 4
  • Upper GI: Grade I: 0, Grade II: 1, Grade III: N/A, Grade IV: N/A
  • The cumulative incidence of grade 2-4 acute GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death, relapse, and graft failure.
Time Frame Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
-Donors are not evaluable for this outcome measure.
Arm/Group Title Arm 1: Donors Arm 2: Recipients
Hide Arm/Group 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.
-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
Overall Number of Participants Analyzed 0 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.3636
(0.1690 to 0.5623)
8.Secondary Outcome
Title Cumulative Incidence of Chronic GvHD in Patients Who Have Undergone Transplantation of Hematopoietic Cells Mobilized With BL-8040 (Arm 2 Recipients Only)
Hide Description
  • Chronic GVHD rate and severity for the first 365 days after PBSC infusion will be assessed based on the NIH criteria
  • The cumulative incidence of chronic GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death, relapse, and graft failure.
Time Frame From Day 100 through 1 year after transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
-Donors are not evaluable for this outcome measure.
Arm/Group Title Arm 1: Donors Arm 2: Recipients
Hide Arm/Group 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.
-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
Overall Number of Participants Analyzed 0 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.5000
(0.2676 to 0.6946)
9.Secondary Outcome
Title Number of Participants Who Collect 5 x 106 CD34+ Cells/kg of Recipient Weight in a Single Leukapheresis and in 2 Leukapheresis Sessions (Arm 1 Donors Only)
Hide Description [Not Specified]
Time Frame Up to Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
-Recipients are not evaluable for this outcome measure. -Only donors who received 1.25 mg/kg of BL-8040 were evaluable for this outcome measure (the 1st 10 donors received 1.00 mg/kg of BL-8040)
Arm/Group Title Arm 1: Donors Arm 2: Recipients
Hide Arm/Group 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.
-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
Overall Number of Participants Analyzed 9 0
Measure Type: Count of Participants
Unit of Measure: Participants
9
 100.0%
10.Secondary Outcome
Title Incidence of CMV Reactivation After Transplantation of Hematopoietic Cells Mobilized With BL-8040 in CMV Seropositive Recipients
Hide Description -CMV reactivation will be defined as a positive test for CMV viremia as determined by an antigenemia assay or quantitative PCR that results in the administration of antiviral treatment directed against CMV
Time Frame Up to 1 year after transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
-Donors are not evaluable for this outcome measure.
Arm/Group Title Arm 1: Donors Arm 2: Recipients
Hide Arm/Group 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.
-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
Overall Number of Participants Analyzed 0 22
Measure Type: Count of Participants
Unit of Measure: Participants
8
  36.4%
11.Secondary Outcome
Title Cumulative Incidence of Treatment-related Mortality After Transplantation of Hematopoietic Cells Mobilized With BL-8040 (Arm 2 Recipients Only)
Hide Description -Death that results from a transplant procedure related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause
Time Frame Up to 1 year after transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
-Donors are not evaluable for this outcome measure.
Arm/Group Title Arm 1: Donors Arm 2: Recipients
Hide Arm/Group 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.
-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
Overall Number of Participants Analyzed 0 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.2273
(0.0792 to 0.4208)
12.Secondary Outcome
Title Incidence of Disease Relapse/Progression After Transplantation of Hematopoietic Cells Mobilized With BL-8040 (Arm 2 Recipients Only)
Hide Description -Disease relapse occurs in recipients who entered transplant in CR. Progression occurs in recipients with existent disease at transplant who meet criteria for progressive disease post-transplant. A recipient will be considered relapsed when there is a recurrence of the original malignant disease after transplantation. Date of relapse/progression is defined as the date at which the first observation of hematologic, radiographic, or cytogenetic changes which signify progression/relapse is made
Time Frame Up to 3 years after transplantation
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Probability of Event Free Survival After Transplantation of Hematopoietic Cells Mobilized With BL-8040 (Arm 2 Recipients Only)
Hide Description -An event is defined as either graft failure, disease relapse as evidenced by hematologic, radiographic, or cytogenetic changes, or death. The event free survival is the time from Day 0 to occurrence of the first event.
Time Frame Up to 3 years after transplantation
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Probability of Overall Survival After Transplantation of Hematopoietic Cells Mobilized With BL-8040 (Arm 2 Recipients Only)
Hide Description -The time from Day 0 to death
Time Frame Up to 3 years after transplantation
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Median Peripheral Blood CD34+ Cell Count (Arm 1 Donor Only)
Hide Description [Not Specified]
Time Frame At 3-4 hours after BL-8040
Hide Outcome Measure Data
Hide Analysis Population Description
Recipients are not evaluable for this outcome measure.
Arm/Group Title Arm 1: Donors Arm 2: Recipients
Hide Arm/Group 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.
-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
Overall Number of Participants Analyzed 25 0
Median (Full Range)
Unit of Measure: CD34/microliters
15
(1 to 46)
Time Frame -Adverse events for donors were collected from the date the participant signed the consent form through 30 days after the last dose of BL-8040. In addition, any adverse events at least possibly related to BL-8040 that occurs up to 5 years after the BL-8040 dose should be recorded. -Adverse events for recipients were collected from the start of the conditioning regimen until Day +100 post transplant. Only grade 3-5 non-hematologic adverse events will be collected.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: Donors Arm 2: Recipients
Hide Arm/Group 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. -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
All-Cause Mortality
Arm 1: Donors Arm 2: Recipients
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   11/22 (50.00%) 
Hide Serious Adverse Events
Arm 1: Donors Arm 2: Recipients
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   12/22 (54.55%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  0/25 (0.00%)  2/22 (9.09%) 
Gastrointestinal disorders     
Diarrhea  1  0/25 (0.00%)  3/22 (13.64%) 
Mucositis oral  1  0/25 (0.00%)  1/22 (4.55%) 
Nausea  1  0/25 (0.00%)  1/22 (4.55%) 
Vomiting  1  0/25 (0.00%)  1/22 (4.55%) 
General disorders     
Fever  1  0/25 (0.00%)  1/22 (4.55%) 
Generalized weakness  1  0/25 (0.00%)  1/22 (4.55%) 
Infections and infestations     
Sepsis  1  0/25 (0.00%)  2/22 (9.09%) 
Upper respiratory infection  1  0/25 (0.00%)  1/22 (4.55%) 
Injury, poisoning and procedural complications     
Fall  1  0/25 (0.00%)  1/22 (4.55%) 
Nervous system disorders     
Headache  1  0/25 (0.00%)  1/22 (4.55%) 
Psychiatric disorders     
Delirium  1  0/25 (0.00%)  1/22 (4.55%) 
Renal and urinary disorders     
Acute kidney injury  1  0/25 (0.00%)  3/22 (13.64%) 
Reproductive system and breast disorders     
Genital edema  1  0/25 (0.00%)  1/22 (4.55%) 
Testicular pain  1  0/25 (0.00%)  1/22 (4.55%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory failure  1  0/25 (0.00%)  1/22 (4.55%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: Donors Arm 2: Recipients
Affected / at Risk (%) Affected / at Risk (%)
Total   25/25 (100.00%)   22/22 (100.00%) 
Blood and lymphatic system disorders     
Anemia  1  17/25 (68.00%)  0/22 (0.00%) 
Febrile neutropenia  1  0/25 (0.00%)  7/22 (31.82%) 
Cardiac disorders     
Acute systolic heart failure  1  0/25 (0.00%)  1/22 (4.55%) 
Atrial fibrillation  1  1/25 (4.00%)  0/22 (0.00%) 
Chest pain-cardiac  1  0/25 (0.00%)  1/22 (4.55%) 
Sinus brachycardia  1  4/25 (16.00%)  0/22 (0.00%) 
Sinus tachycardia  1  2/25 (8.00%)  0/22 (0.00%) 
Eye disorders     
Eye pain  1  1/25 (4.00%)  0/22 (0.00%) 
Watering eyes  1  1/25 (4.00%)  0/22 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/25 (0.00%)  1/22 (4.55%) 
Colitis  1  0/25 (0.00%)  1/22 (4.55%) 
Diarrhea  1  0/25 (0.00%)  1/22 (4.55%) 
Esophagitis  1  0/25 (0.00%)  1/22 (4.55%) 
Gastrointestinal reflux disease  1  1/25 (4.00%)  0/22 (0.00%) 
Mucositis oral  1  0/25 (0.00%)  7/22 (31.82%) 
Nausea  1  1/25 (4.00%)  2/22 (9.09%) 
Oral dysesthesia  1  6/25 (24.00%)  0/22 (0.00%) 
Toothache  1  1/25 (4.00%)  0/22 (0.00%) 
Vomiting  1  2/25 (8.00%)  0/22 (0.00%) 
General disorders     
Chills  1  1/25 (4.00%)  0/22 (0.00%) 
Edema limbs-anasarca  1  0/25 (0.00%)  1/22 (4.55%) 
Fatigue  1  3/25 (12.00%)  2/22 (9.09%) 
Fever  1  1/25 (4.00%)  0/22 (0.00%) 
Infusion related reaction  1  1/25 (4.00%)  0/22 (0.00%) 
Injection site reaction  1  20/25 (80.00%)  0/22 (0.00%) 
Localized edema  1  1/25 (4.00%)  0/22 (0.00%) 
Pain  1  1/25 (4.00%)  0/22 (0.00%) 
Vibration sensation  1  1/25 (4.00%)  0/22 (0.00%) 
Hepatobiliary disorders     
Hepatic failure  1  0/25 (0.00%)  1/22 (4.55%) 
Immune system disorders     
Allergic reaction  1  20/25 (80.00%)  0/22 (0.00%) 
Infections and infestations     
Bacteremia-Klebsiella pneumoniae  1  0/25 (0.00%)  1/22 (4.55%) 
Bacteremia-VRE  1  0/25 (0.00%)  1/22 (4.55%) 
Catheter related infection  1  0/25 (0.00%)  1/22 (4.55%) 
Clostridium difficile  1  0/25 (0.00%)  2/22 (9.09%) 
Hepatitis B Core Ab positive  1  2/25 (8.00%)  0/22 (0.00%) 
Lung infection  1  0/25 (0.00%)  2/22 (9.09%) 
Mild head cold  1  1/25 (4.00%)  0/22 (0.00%) 
Oral thrush  1  0/25 (0.00%)  1/22 (4.55%) 
Papulopustular rash  1  1/25 (4.00%)  0/22 (0.00%) 
Skin infection  1  0/25 (0.00%)  1/22 (4.55%) 
Urinary tract infection  1  0/25 (0.00%)  2/22 (9.09%) 
Injury, poisoning and procedural complications     
Bruising  1  1/25 (4.00%)  0/22 (0.00%) 
Investigations     
Activated partial thromboplastin time prolonged  1  1/25 (4.00%)  0/22 (0.00%) 
Alanine aminotransferase increased  1  1/25 (4.00%)  2/22 (9.09%) 
Alkaline phosphatase increased  1  1/25 (4.00%)  0/22 (0.00%) 
Aspartate aminotransferase increased  1  0/25 (0.00%)  1/22 (4.55%) 
Blood bilirubin increased  1  0/25 (0.00%)  1/22 (4.55%) 
Cholesterol high  1  6/25 (24.00%)  0/22 (0.00%) 
GGT increased  1  0/25 (0.00%)  1/22 (4.55%) 
Hemoglobin increased  1  2/25 (8.00%)  0/22 (0.00%) 
Lymphocyte count decreased  1  8/25 (32.00%)  0/22 (0.00%) 
Lymphocyte count increased  1  22/25 (88.00%)  0/22 (0.00%) 
Neutrophil count decreased  1  1/25 (4.00%)  0/22 (0.00%) 
Platelet count decreased  1  22/25 (88.00%)  0/22 (0.00%) 
White blood cell decreased  1  2/25 (8.00%)  0/22 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  0/25 (0.00%)  1/22 (4.55%) 
Dehydration  1  0/25 (0.00%)  1/22 (4.55%) 
Hypercalcemia  1  0/25 (0.00%)  1/22 (4.55%) 
Hyperglycemia  1  3/25 (12.00%)  4/22 (18.18%) 
Hyperkalemia  1  1/25 (4.00%)  2/22 (9.09%) 
Hypermagnesemia  1  0/25 (0.00%)  1/22 (4.55%) 
Hypertriglyceridemia  1  4/25 (16.00%)  0/22 (0.00%) 
Hyperuricemia  1  1/25 (4.00%)  2/22 (9.09%) 
Hypocalcemia  1  10/25 (40.00%)  0/22 (0.00%) 
Hypokalemia  1  0/25 (0.00%)  4/22 (18.18%) 
Hypomagnesemia  1  1/25 (4.00%)  0/22 (0.00%) 
Hyponatremia  1  1/25 (4.00%)  1/22 (4.55%) 
Hypophosphatemia  1  0/25 (0.00%)  6/22 (27.27%) 
Type II diabetes  1  1/25 (4.00%)  0/22 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/25 (4.00%)  0/22 (0.00%) 
Back pain  1  0/25 (0.00%)  2/22 (9.09%) 
Bone pain  1  2/25 (8.00%)  0/22 (0.00%) 
Foot pain  1  1/25 (4.00%)  0/22 (0.00%) 
Leg/knee pain  1  1/25 (4.00%)  0/22 (0.00%) 
Pain in extremity  1  1/25 (4.00%)  0/22 (0.00%) 
Nervous system disorders     
Dizziness  1  1/25 (4.00%)  0/22 (0.00%) 
Dysesthesia  1  1/25 (4.00%)  0/22 (0.00%) 
Dysgeusia  1  1/25 (4.00%)  0/22 (0.00%) 
Headache  1  3/25 (12.00%)  3/22 (13.64%) 
Paresthesia  1  3/25 (12.00%)  0/22 (0.00%) 
Syncope  1  1/25 (4.00%)  1/22 (4.55%) 
Psychiatric disorders     
Anxiety  1  1/25 (4.00%)  0/22 (0.00%) 
Insomnia  1  2/25 (8.00%)  0/22 (0.00%) 
Renal and urinary disorders     
Cystitis noninfective  1  0/25 (0.00%)  1/22 (4.55%) 
Renal failure  1  0/25 (0.00%)  1/22 (4.55%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  2/25 (8.00%)  0/22 (0.00%) 
Dyspnea  1  1/25 (4.00%)  0/22 (0.00%) 
Epistaxis  1  0/25 (0.00%)  1/22 (4.55%) 
Hypoxia  1  0/25 (0.00%)  4/22 (18.18%) 
Pneumonitis  1  0/25 (0.00%)  1/22 (4.55%) 
Pulmonary edema  1  0/25 (0.00%)  1/22 (4.55%) 
Respiratory failure  1  0/25 (0.00%)  1/22 (4.55%) 
Sore throat  1  0/25 (0.00%)  1/22 (4.55%) 
Skin and subcutaneous tissue disorders     
Rash maculo-papular  1  1/25 (4.00%)  0/22 (0.00%) 
Scrotal pruritus  1  0/25 (0.00%)  1/22 (4.55%) 
Vascular disorders     
Hypertension  1  16/25 (64.00%)  11/22 (50.00%) 
Hypotension  1  2/25 (8.00%)  1/22 (4.55%) 
Veno-occlusive disease  1  0/25 (0.00%)  1/22 (4.55%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Geoffrey Uy, M.D.
Organization: Washington University School of Medicine
Phone: 314-454-8304
EMail: guy@wustl.edu
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02639559    
Other Study ID Numbers: 201602037
First Submitted: December 17, 2015
First Posted: December 24, 2015
Results First Submitted: April 9, 2019
Results First Posted: May 1, 2019
Last Update Posted: April 8, 2021