Trial Outcomes & Findings for Ph2 NK Cell Enriched DCIs w/wo RLR9 Agonist, DUK-CPG-001 From Donors Following Allogeneic SCT (NCT NCT02452697)
NCT ID: NCT02452697
Last Updated: 2024-02-20
Results Overview
To evaluate the one-year progression-free survival rate in patients receiving NK cell-enriched DLI administered alone from a 7-8/8 HLA-matched related or unrelated donor or 4-6/8 HLA-matched related donor following reduced intensity or non-ablative allogeneic stem cell transplantation and to evaluate the one-year progression-free survival rate in patients receiving NK cell-enriched DLI administered with a Toll-like receptor 9 (TLR9) ligand, DUK-CPG-001, from a 7-8/8 HLA-matched related or unrelated donor or 4-6/8 HLA-matched related donor following reduced intensity or non-ablative allogeneic stem cell transplantation
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2024-02-20
Participant Flow
Participant milestones
| Measure |
Cohort A - NK Cell Enriched-DLI Only
Patients with a 7-8/8 human leukocyte antigen (HLA)-matched related or unrelated donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) only
NK Cell enriched-DLI only: The first NK cell-enriched DLI will be administered one to six months post transplant. The second NK cell-enriched DLI will be administered one to three months post the first infusion, in patients who have ≤ grade II aGVHD at the time of infusion and have not had unacceptable toxicities from the first infusion. Patients will continue on their stable dose of immunosuppressive agents started for therapy of acute GVHD before the NK cell-enriched DLI, and will not taper until at least 6 weeks following the each NK cell-enriched DLI (unless disease progression or patient toxicity from the agents requires earlier taper). The donor NK cells will be infused over 30 minutes intravenously.
If signs of GVHD occur after NK cell-enriched DLI, immunosuppressive agents may be started.
|
Cohort A - NK-DLI + DUK-CPG-001
Patients with a 7-8/8 human leukocyte antigen (HLA)-matched related or unrelated donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) and investigational DUK-CPG-001
NK-DLI + DUK-CPG-001: DUK-CPG-001 was synthesized by Agilent Technologies (Boulder, CO) in 2013. Bulk DUK-CPG-001 has been resuspended in normal saline with a final concentration of 10 mg/mL, aliquoted into 0.75 mL (7.5 mg) per tube and stored at -20oC in the Investigational Chemotherapy Service pharmacy at Duke. DUK-CPG-001 will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI. The drug will be used within 4 hours of thawing.
On the day of NK cell-enriched DLI, for those patients who are randomized to receive DUK-CPG-001, 0.5 mL (5 mg) aliquots of DUK-CPG-001 will be dispensed to nurse. It will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI.
|
Cohort B - NK Cell Enriched-DLI Only
Patients with a 4-6/8 human leukocyte antigen (HLA)-matched related donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) only
NK Cell enriched-DLI only: The first NK cell-enriched DLI will be administered one to six months post transplant. The second NK cell-enriched DLI will be administered one to three months post the first infusion, in patients who have ≤ grade II aGVHD at the time of infusion and have not had unacceptable toxicities from the first infusion. Patients will continue on their stable dose of immunosuppressive agents started for therapy of acute GVHD before the NK cell-enriched DLI, and will not taper until at least 6 weeks following the each NK cell-enriched DLI (unless disease progression or patient toxicity from the agents requires earlier taper). The donor NK cells will be infused over 30 minutes intravenously.
If signs of GVHD occur after NK cell-enriched DLI, immunosuppressive agents may be started.
|
Cohort B - NK-DLI + DUK-CPG-001
Patients with a 4-6/8 human leukocyte antigen (HLA)-matched related donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) and investigational DUK-CPG-001
NK-DLI + DUK-CPG-001: DUK-CPG-001 was synthesized by Agilent Technologies (Boulder, CO) in 2013. Bulk DUK-CPG-001 has been resuspended in normal saline with a final concentration of 10 mg/mL, aliquoted into 0.75 mL (7.5 mg) per tube and stored at -20oC in the Investigational Chemotherapy Service pharmacy at Duke. DUK-CPG-001 will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI. The drug will be used within 4 hours of thawing.
On the day of NK cell-enriched DLI, for those patients who are randomized to receive DUK-CPG-001, 0.5 mL (5 mg) aliquots of DUK-CPG-001 will be dispensed to nurse. It will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
4
|
7
|
|
Overall Study
COMPLETED
|
7
|
5
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
4
|
5
|
Reasons for withdrawal
| Measure |
Cohort A - NK Cell Enriched-DLI Only
Patients with a 7-8/8 human leukocyte antigen (HLA)-matched related or unrelated donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) only
NK Cell enriched-DLI only: The first NK cell-enriched DLI will be administered one to six months post transplant. The second NK cell-enriched DLI will be administered one to three months post the first infusion, in patients who have ≤ grade II aGVHD at the time of infusion and have not had unacceptable toxicities from the first infusion. Patients will continue on their stable dose of immunosuppressive agents started for therapy of acute GVHD before the NK cell-enriched DLI, and will not taper until at least 6 weeks following the each NK cell-enriched DLI (unless disease progression or patient toxicity from the agents requires earlier taper). The donor NK cells will be infused over 30 minutes intravenously.
If signs of GVHD occur after NK cell-enriched DLI, immunosuppressive agents may be started.
|
Cohort A - NK-DLI + DUK-CPG-001
Patients with a 7-8/8 human leukocyte antigen (HLA)-matched related or unrelated donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) and investigational DUK-CPG-001
NK-DLI + DUK-CPG-001: DUK-CPG-001 was synthesized by Agilent Technologies (Boulder, CO) in 2013. Bulk DUK-CPG-001 has been resuspended in normal saline with a final concentration of 10 mg/mL, aliquoted into 0.75 mL (7.5 mg) per tube and stored at -20oC in the Investigational Chemotherapy Service pharmacy at Duke. DUK-CPG-001 will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI. The drug will be used within 4 hours of thawing.
On the day of NK cell-enriched DLI, for those patients who are randomized to receive DUK-CPG-001, 0.5 mL (5 mg) aliquots of DUK-CPG-001 will be dispensed to nurse. It will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI.
|
Cohort B - NK Cell Enriched-DLI Only
Patients with a 4-6/8 human leukocyte antigen (HLA)-matched related donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) only
NK Cell enriched-DLI only: The first NK cell-enriched DLI will be administered one to six months post transplant. The second NK cell-enriched DLI will be administered one to three months post the first infusion, in patients who have ≤ grade II aGVHD at the time of infusion and have not had unacceptable toxicities from the first infusion. Patients will continue on their stable dose of immunosuppressive agents started for therapy of acute GVHD before the NK cell-enriched DLI, and will not taper until at least 6 weeks following the each NK cell-enriched DLI (unless disease progression or patient toxicity from the agents requires earlier taper). The donor NK cells will be infused over 30 minutes intravenously.
If signs of GVHD occur after NK cell-enriched DLI, immunosuppressive agents may be started.
|
Cohort B - NK-DLI + DUK-CPG-001
Patients with a 4-6/8 human leukocyte antigen (HLA)-matched related donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) and investigational DUK-CPG-001
NK-DLI + DUK-CPG-001: DUK-CPG-001 was synthesized by Agilent Technologies (Boulder, CO) in 2013. Bulk DUK-CPG-001 has been resuspended in normal saline with a final concentration of 10 mg/mL, aliquoted into 0.75 mL (7.5 mg) per tube and stored at -20oC in the Investigational Chemotherapy Service pharmacy at Duke. DUK-CPG-001 will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI. The drug will be used within 4 hours of thawing.
On the day of NK cell-enriched DLI, for those patients who are randomized to receive DUK-CPG-001, 0.5 mL (5 mg) aliquots of DUK-CPG-001 will be dispensed to nurse. It will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI.
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
4
|
4
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Overall Study
still in follow-up
|
2
|
2
|
1
|
3
|
Baseline Characteristics
Ph2 NK Cell Enriched DCIs w/wo RLR9 Agonist, DUK-CPG-001 From Donors Following Allogeneic SCT
Baseline characteristics by cohort
| Measure |
Cohort A - NK Cell Enriched-DLI Only
n=14 Participants
Patients with a 7-8/8 human leukocyte antigen (HLA)-matched related or unrelated donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) only
NK Cell enriched-DLI only: The first NK cell-enriched DLI will be administered one to six months post transplant. The second NK cell-enriched DLI will be administered one to three months post the first infusion, in patients who have ≤ grade II aGVHD at the time of infusion and have not had unacceptable toxicities from the first infusion. Patients will continue on their stable dose of immunosuppressive agents started for therapy of acute GVHD before the NK cell-enriched DLI, and will not taper until at least 6 weeks following the each NK cell-enriched DLI (unless disease progression or patient toxicity from the agents requires earlier taper). The donor NK cells will be infused over 30 minutes intravenously.
If signs of GVHD occur after NK cell-enriched DLI, immunosuppressive agents may be started.
|
Cohort A - NK-DLI + DUK-CPG-001
n=11 Participants
Patients with a 7-8/8 human leukocyte antigen (HLA)-matched related or unrelated donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) and investigational DUK-CPG-001
NK-DLI + DUK-CPG-001: DUK-CPG-001 was synthesized by Agilent Technologies (Boulder, CO) in 2013. Bulk DUK-CPG-001 has been resuspended in normal saline with a final concentration of 10 mg/mL, aliquoted into 0.75 mL (7.5 mg) per tube and stored at -20oC in the Investigational Chemotherapy Service pharmacy at Duke. DUK-CPG-001 will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI. The drug will be used within 4 hours of thawing.
On the day of NK cell-enriched DLI, for those patients who are randomized to receive DUK-CPG-001, 0.5 mL (5 mg) aliquots of DUK-CPG-001 will be dispensed to nurse. It will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI.
|
Cohort B - NK Cell Enriched-DLI Only
n=4 Participants
Patients with a 4-6/8 human leukocyte antigen (HLA)-matched related donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) only
NK Cell enriched-DLI only: The first NK cell-enriched DLI will be administered one to six months post transplant. The second NK cell-enriched DLI will be administered one to three months post the first infusion, in patients who have ≤ grade II aGVHD at the time of infusion and have not had unacceptable toxicities from the first infusion. Patients will continue on their stable dose of immunosuppressive agents started for therapy of acute GVHD before the NK cell-enriched DLI, and will not taper until at least 6 weeks following the each NK cell-enriched DLI (unless disease progression or patient toxicity from the agents requires earlier taper). The donor NK cells will be infused over 30 minutes intravenously.
If signs of GVHD occur after NK cell-enriched DLI, immunosuppressive agents may be started.
|
Cohort B - NK-DLI + DUK-CPG-001
n=7 Participants
Patients with a 4-6/8 human leukocyte antigen (HLA)-matched related donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) and investigational DUK-CPG-001
NK-DLI + DUK-CPG-001: DUK-CPG-001 was synthesized by Agilent Technologies (Boulder, CO) in 2013. Bulk DUK-CPG-001 has been resuspended in normal saline with a final concentration of 10 mg/mL, aliquoted into 0.75 mL (7.5 mg) per tube and stored at -20oC in the Investigational Chemotherapy Service pharmacy at Duke. DUK-CPG-001 will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI. The drug will be used within 4 hours of thawing.
On the day of NK cell-enriched DLI, for those patients who are randomized to receive DUK-CPG-001, 0.5 mL (5 mg) aliquots of DUK-CPG-001 will be dispensed to nurse. It will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 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
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
4 participants
n=5 Participants
|
7 participants
n=4 Participants
|
36 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Data not collected on 13 participants.
To evaluate the one-year progression-free survival rate in patients receiving NK cell-enriched DLI administered alone from a 7-8/8 HLA-matched related or unrelated donor or 4-6/8 HLA-matched related donor following reduced intensity or non-ablative allogeneic stem cell transplantation and to evaluate the one-year progression-free survival rate in patients receiving NK cell-enriched DLI administered with a Toll-like receptor 9 (TLR9) ligand, DUK-CPG-001, from a 7-8/8 HLA-matched related or unrelated donor or 4-6/8 HLA-matched related donor following reduced intensity or non-ablative allogeneic stem cell transplantation
Outcome measures
| Measure |
Cohort A - NK Cell Enriched-DLI Only
n=8 Participants
Patients with a 7-8/8 human leukocyte antigen (HLA)-matched related or unrelated donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) only
NK Cell enriched-DLI only: The first NK cell-enriched DLI will be administered one to six months post transplant. The second NK cell-enriched DLI will be administered one to three months post the first infusion, in patients who have ≤ grade II aGVHD at the time of infusion and have not had unacceptable toxicities from the first infusion. Patients will continue on their stable dose of immunosuppressive agents started for therapy of acute GVHD before the NK cell-enriched DLI, and will not taper until at least 6 weeks following the each NK cell-enriched DLI (unless disease progression or patient toxicity from the agents requires earlier taper). The donor NK cells will be infused over 30 minutes intravenously.
If signs of GVHD occur after NK cell-enriched DLI, immunosuppressive agents may be started.
|
Cohort A - NK-DLI + DUK-CPG-001
n=6 Participants
Patients with a 7-8/8 human leukocyte antigen (HLA)-matched related or unrelated donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) and investigational DUK-CPG-001
NK-DLI + DUK-CPG-001: DUK-CPG-001 was synthesized by Agilent Technologies (Boulder, CO) in 2013. Bulk DUK-CPG-001 has been resuspended in normal saline with a final concentration of 10 mg/mL, aliquoted into 0.75 mL (7.5 mg) per tube and stored at -20oC in the Investigational Chemotherapy Service pharmacy at Duke. DUK-CPG-001 will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI. The drug will be used within 4 hours of thawing.
On the day of NK cell-enriched DLI, for those patients who are randomized to receive DUK-CPG-001, 0.5 mL (5 mg) aliquots of DUK-CPG-001 will be dispensed to nurse. It will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI.
|
Cohort B - NK Cell Enriched-DLI Only
n=4 Participants
Patients with a 4-6/8 human leukocyte antigen (HLA)-matched related donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) only
NK Cell enriched-DLI only: The first NK cell-enriched DLI will be administered one to six months post transplant. The second NK cell-enriched DLI will be administered one to three months post the first infusion, in patients who have ≤ grade II aGVHD at the time of infusion and have not had unacceptable toxicities from the first infusion. Patients will continue on their stable dose of immunosuppressive agents started for therapy of acute GVHD before the NK cell-enriched DLI, and will not taper until at least 6 weeks following the each NK cell-enriched DLI (unless disease progression or patient toxicity from the agents requires earlier taper). The donor NK cells will be infused over 30 minutes intravenously.
If signs of GVHD occur after NK cell-enriched DLI, immunosuppressive agents may be started.
|
Cohort B - NK-DLI + DUK-CPG-001
n=5 Participants
Patients with a 4-6/8 human leukocyte antigen (HLA)-matched related donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) and investigational DUK-CPG-001
NK-DLI + DUK-CPG-001: DUK-CPG-001 was synthesized by Agilent Technologies (Boulder, CO) in 2013. Bulk DUK-CPG-001 has been resuspended in normal saline with a final concentration of 10 mg/mL, aliquoted into 0.75 mL (7.5 mg) per tube and stored at -20oC in the Investigational Chemotherapy Service pharmacy at Duke. DUK-CPG-001 will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI. The drug will be used within 4 hours of thawing.
On the day of NK cell-enriched DLI, for those patients who are randomized to receive DUK-CPG-001, 0.5 mL (5 mg) aliquots of DUK-CPG-001 will be dispensed to nurse. It will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI.
|
|---|---|---|---|---|
|
Progression-Free Survival (PFS) Rate
|
0.75 proportion of participants
Interval 0.31 to 0.93
|
1.00 proportion of participants
Interval 1.0 to 1.0
|
0.50 proportion of participants
Interval 0.06 to 0.84
|
0.80 proportion of participants
Interval 0.2 to 0.97
|
PRIMARY outcome
Timeframe: Up to 100 daysPopulation: Data not collected on 13 participants.
Unacceptable toxicity is defined as any of the following related to the DLI procedure: 1. Grade \> III aGVHD of the gut or liver or Grade IV aGVHD of the skin lasting \> 7 days; 2. Grade 4 toxicity from the procedure in the cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic categories that lasts \> 5 days; 3. Treatment-related death caused by the toxicities related to DLI procedure.
Outcome measures
| Measure |
Cohort A - NK Cell Enriched-DLI Only
n=8 Participants
Patients with a 7-8/8 human leukocyte antigen (HLA)-matched related or unrelated donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) only
NK Cell enriched-DLI only: The first NK cell-enriched DLI will be administered one to six months post transplant. The second NK cell-enriched DLI will be administered one to three months post the first infusion, in patients who have ≤ grade II aGVHD at the time of infusion and have not had unacceptable toxicities from the first infusion. Patients will continue on their stable dose of immunosuppressive agents started for therapy of acute GVHD before the NK cell-enriched DLI, and will not taper until at least 6 weeks following the each NK cell-enriched DLI (unless disease progression or patient toxicity from the agents requires earlier taper). The donor NK cells will be infused over 30 minutes intravenously.
If signs of GVHD occur after NK cell-enriched DLI, immunosuppressive agents may be started.
|
Cohort A - NK-DLI + DUK-CPG-001
n=6 Participants
Patients with a 7-8/8 human leukocyte antigen (HLA)-matched related or unrelated donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) and investigational DUK-CPG-001
NK-DLI + DUK-CPG-001: DUK-CPG-001 was synthesized by Agilent Technologies (Boulder, CO) in 2013. Bulk DUK-CPG-001 has been resuspended in normal saline with a final concentration of 10 mg/mL, aliquoted into 0.75 mL (7.5 mg) per tube and stored at -20oC in the Investigational Chemotherapy Service pharmacy at Duke. DUK-CPG-001 will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI. The drug will be used within 4 hours of thawing.
On the day of NK cell-enriched DLI, for those patients who are randomized to receive DUK-CPG-001, 0.5 mL (5 mg) aliquots of DUK-CPG-001 will be dispensed to nurse. It will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI.
|
Cohort B - NK Cell Enriched-DLI Only
n=4 Participants
Patients with a 4-6/8 human leukocyte antigen (HLA)-matched related donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) only
NK Cell enriched-DLI only: The first NK cell-enriched DLI will be administered one to six months post transplant. The second NK cell-enriched DLI will be administered one to three months post the first infusion, in patients who have ≤ grade II aGVHD at the time of infusion and have not had unacceptable toxicities from the first infusion. Patients will continue on their stable dose of immunosuppressive agents started for therapy of acute GVHD before the NK cell-enriched DLI, and will not taper until at least 6 weeks following the each NK cell-enriched DLI (unless disease progression or patient toxicity from the agents requires earlier taper). The donor NK cells will be infused over 30 minutes intravenously.
If signs of GVHD occur after NK cell-enriched DLI, immunosuppressive agents may be started.
|
Cohort B - NK-DLI + DUK-CPG-001
n=5 Participants
Patients with a 4-6/8 human leukocyte antigen (HLA)-matched related donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) and investigational DUK-CPG-001
NK-DLI + DUK-CPG-001: DUK-CPG-001 was synthesized by Agilent Technologies (Boulder, CO) in 2013. Bulk DUK-CPG-001 has been resuspended in normal saline with a final concentration of 10 mg/mL, aliquoted into 0.75 mL (7.5 mg) per tube and stored at -20oC in the Investigational Chemotherapy Service pharmacy at Duke. DUK-CPG-001 will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI. The drug will be used within 4 hours of thawing.
On the day of NK cell-enriched DLI, for those patients who are randomized to receive DUK-CPG-001, 0.5 mL (5 mg) aliquots of DUK-CPG-001 will be dispensed to nurse. It will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI.
|
|---|---|---|---|---|
|
Number of Participants With Unacceptable Toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 100 daysTo evaluate the recovery of immune cell populations pre and post infusion in patients receiving NK cell-enriched DLI administered alone or administered with TLR9 ligand, DUK-CPG-001.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 100 daysPopulation: Analysis of samples was not and never will be conducted, data was not collected for this Outcome Measure.
Pre and post infusion immune function will be reported in patients receiving NK cell-enriched DLI administered alone or administered with TLR9 ligand, DUK-CPG-001.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 100 daysPopulation: Analysis of samples was not and never will be conducted, data was not collected for this Outcome Measure.
Pre and post infusion immune function will be reported in patients receiving NK cell-enriched DLI administered alone or administered with TLR9 ligand, DUK-CPG-001.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 100 daysPopulation: Analysis of samples was not and never will be conducted, data was not collected for this Outcome Measure.
Pre and post infusion immune function will be reported in patients receiving NK cell-enriched DLI administered alone or administered with TLR9 ligand, DUK-CPG-001.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 100 daysPopulation: Analysis of samples was not and never will be conducted, data was not collected for this Outcome Measure.
Pre and post infusion immune function will be reported in patients receiving NK cell-enriched DLI administered alone or administered with TLR9 ligand, DUK-CPG-001.
Outcome measures
Outcome data not reported
Adverse Events
Cohort A - NK Cell Enriched-DLI Only
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Cohort A - NK-DLI + DUK-CPG-001
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort B - NK Cell Enriched-DLI Only
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort B - NK-DLI + DUK-CPG-001
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A - NK Cell Enriched-DLI Only
n=14 participants at risk
Patients with a 7-8/8 human leukocyte antigen (HLA)-matched related or unrelated donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) only
NK Cell enriched-DLI only: The first NK cell-enriched DLI will be administered one to six months post transplant. The second NK cell-enriched DLI will be administered one to three months post the first infusion, in patients who have ≤ grade II aGVHD at the time of infusion and have not had unacceptable toxicities from the first infusion. Patients will continue on their stable dose of immunosuppressive agents started for therapy of acute GVHD before the NK cell-enriched DLI, and will not taper until at least 6 weeks following the each NK cell-enriched DLI (unless disease progression or patient toxicity from the agents requires earlier taper). The donor NK cells will be infused over 30 minutes intravenously.
If signs of GVHD occur after NK cell-enriched DLI, immunosuppressive agents may be started.
|
Cohort A - NK-DLI + DUK-CPG-001
n=11 participants at risk
Patients with a 7-8/8 human leukocyte antigen (HLA)-matched related or unrelated donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) and investigational DUK-CPG-001
NK-DLI + DUK-CPG-001: DUK-CPG-001 was synthesized by Agilent Technologies (Boulder, CO) in 2013. Bulk DUK-CPG-001 has been resuspended in normal saline with a final concentration of 10 mg/mL, aliquoted into 0.75 mL (7.5 mg) per tube and stored at -20oC in the Investigational Chemotherapy Service pharmacy at Duke. DUK-CPG-001 will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI. The drug will be used within 4 hours of thawing.
On the day of NK cell-enriched DLI, for those patients who are randomized to receive DUK-CPG-001, 0.5 mL (5 mg) aliquots of DUK-CPG-001 will be dispensed to nurse. It will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI.
|
Cohort B - NK Cell Enriched-DLI Only
n=4 participants at risk
Patients with a 4-6/8 human leukocyte antigen (HLA)-matched related donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) only
NK Cell enriched-DLI only: The first NK cell-enriched DLI will be administered one to six months post transplant. The second NK cell-enriched DLI will be administered one to three months post the first infusion, in patients who have ≤ grade II aGVHD at the time of infusion and have not had unacceptable toxicities from the first infusion. Patients will continue on their stable dose of immunosuppressive agents started for therapy of acute GVHD before the NK cell-enriched DLI, and will not taper until at least 6 weeks following the each NK cell-enriched DLI (unless disease progression or patient toxicity from the agents requires earlier taper). The donor NK cells will be infused over 30 minutes intravenously.
If signs of GVHD occur after NK cell-enriched DLI, immunosuppressive agents may be started.
|
Cohort B - NK-DLI + DUK-CPG-001
n=7 participants at risk
Patients with a 4-6/8 human leukocyte antigen (HLA)-matched related donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) and investigational DUK-CPG-001
NK-DLI + DUK-CPG-001: DUK-CPG-001 was synthesized by Agilent Technologies (Boulder, CO) in 2013. Bulk DUK-CPG-001 has been resuspended in normal saline with a final concentration of 10 mg/mL, aliquoted into 0.75 mL (7.5 mg) per tube and stored at -20oC in the Investigational Chemotherapy Service pharmacy at Duke. DUK-CPG-001 will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI. The drug will be used within 4 hours of thawing.
On the day of NK cell-enriched DLI, for those patients who are randomized to receive DUK-CPG-001, 0.5 mL (5 mg) aliquots of DUK-CPG-001 will be dispensed to nurse. It will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI.
|
|---|---|---|---|---|
|
Eye disorders
Papilledema
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
Other adverse events
| Measure |
Cohort A - NK Cell Enriched-DLI Only
n=14 participants at risk
Patients with a 7-8/8 human leukocyte antigen (HLA)-matched related or unrelated donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) only
NK Cell enriched-DLI only: The first NK cell-enriched DLI will be administered one to six months post transplant. The second NK cell-enriched DLI will be administered one to three months post the first infusion, in patients who have ≤ grade II aGVHD at the time of infusion and have not had unacceptable toxicities from the first infusion. Patients will continue on their stable dose of immunosuppressive agents started for therapy of acute GVHD before the NK cell-enriched DLI, and will not taper until at least 6 weeks following the each NK cell-enriched DLI (unless disease progression or patient toxicity from the agents requires earlier taper). The donor NK cells will be infused over 30 minutes intravenously.
If signs of GVHD occur after NK cell-enriched DLI, immunosuppressive agents may be started.
|
Cohort A - NK-DLI + DUK-CPG-001
n=11 participants at risk
Patients with a 7-8/8 human leukocyte antigen (HLA)-matched related or unrelated donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) and investigational DUK-CPG-001
NK-DLI + DUK-CPG-001: DUK-CPG-001 was synthesized by Agilent Technologies (Boulder, CO) in 2013. Bulk DUK-CPG-001 has been resuspended in normal saline with a final concentration of 10 mg/mL, aliquoted into 0.75 mL (7.5 mg) per tube and stored at -20oC in the Investigational Chemotherapy Service pharmacy at Duke. DUK-CPG-001 will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI. The drug will be used within 4 hours of thawing.
On the day of NK cell-enriched DLI, for those patients who are randomized to receive DUK-CPG-001, 0.5 mL (5 mg) aliquots of DUK-CPG-001 will be dispensed to nurse. It will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI.
|
Cohort B - NK Cell Enriched-DLI Only
n=4 participants at risk
Patients with a 4-6/8 human leukocyte antigen (HLA)-matched related donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) only
NK Cell enriched-DLI only: The first NK cell-enriched DLI will be administered one to six months post transplant. The second NK cell-enriched DLI will be administered one to three months post the first infusion, in patients who have ≤ grade II aGVHD at the time of infusion and have not had unacceptable toxicities from the first infusion. Patients will continue on their stable dose of immunosuppressive agents started for therapy of acute GVHD before the NK cell-enriched DLI, and will not taper until at least 6 weeks following the each NK cell-enriched DLI (unless disease progression or patient toxicity from the agents requires earlier taper). The donor NK cells will be infused over 30 minutes intravenously.
If signs of GVHD occur after NK cell-enriched DLI, immunosuppressive agents may be started.
|
Cohort B - NK-DLI + DUK-CPG-001
n=7 participants at risk
Patients with a 4-6/8 human leukocyte antigen (HLA)-matched related donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) and investigational DUK-CPG-001
NK-DLI + DUK-CPG-001: DUK-CPG-001 was synthesized by Agilent Technologies (Boulder, CO) in 2013. Bulk DUK-CPG-001 has been resuspended in normal saline with a final concentration of 10 mg/mL, aliquoted into 0.75 mL (7.5 mg) per tube and stored at -20oC in the Investigational Chemotherapy Service pharmacy at Duke. DUK-CPG-001 will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI. The drug will be used within 4 hours of thawing.
On the day of NK cell-enriched DLI, for those patients who are randomized to receive DUK-CPG-001, 0.5 mL (5 mg) aliquots of DUK-CPG-001 will be dispensed to nurse. It will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
2/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
25.0%
1/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
7/14 • Up to 12 months
|
27.3%
3/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
|
Metabolism and nutrition disorders
Anorexia
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Psychiatric disorders
Anxiety
|
14.3%
2/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Infections and infestations
Appendicitis
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • Up to 12 months
|
18.2%
2/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Up to 12 months
|
18.2%
2/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Eye disorders
Blurred vision
|
7.1%
1/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Bruising
|
7.1%
1/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
3/14 • Up to 12 months
|
27.3%
3/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
|
Investigations
Creatinine increased
|
28.6%
4/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Psychiatric disorders
Depression
|
21.4%
3/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
21.4%
3/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Nervous system disorders
Dizziness
|
14.3%
2/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Eye disorders
Dry eye
|
14.3%
2/14 • Up to 12 months
|
18.2%
2/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
2/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/14 • Up to 12 months
|
27.3%
3/11 • Up to 12 months
|
25.0%
1/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Nervous system disorders
Dysgeusia
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
2/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Ear and labyrinth disorders
Ear pain
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
General disorders
Edema limbs
|
7.1%
1/14 • Up to 12 months
|
27.3%
3/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
42.9%
3/7 • Up to 12 months
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Eye disorders
Eye pain
|
0.00%
0/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
General disorders
Fatigue
|
28.6%
4/14 • Up to 12 months
|
36.4%
4/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
|
General disorders
Fever
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Eye disorders
Floaters
|
0.00%
0/14 • Up to 12 months
|
18.2%
2/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
14.3%
2/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
35.7%
5/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Vascular disorders
Hypertension
|
50.0%
7/14 • Up to 12 months
|
45.5%
5/11 • Up to 12 months
|
50.0%
2/4 • Up to 12 months
|
42.9%
3/7 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
2/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
2/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
35.7%
5/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
21.4%
3/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Vascular disorders
Hypotension
|
14.3%
2/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Psychiatric disorders
Insomnia
|
14.3%
2/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Investigations
Investigations - Other, specify
|
7.1%
1/14 • Up to 12 months
|
18.2%
2/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Up to 12 months
|
18.2%
2/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
2/14 • Up to 12 months
|
27.3%
3/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Gastrointestinal disorders
Nausea
|
14.3%
2/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/14 • Up to 12 months
|
18.2%
2/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Investigations
Neutrophil count decreased
|
28.6%
4/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
42.9%
3/7 • Up to 12 months
|
|
Metabolism and nutrition disorders
Obesity
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Gastrointestinal disorders
Oral pain
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
General disorders
Pain
|
14.3%
2/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Eye disorders
Papilledema
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
21.4%
3/14 • Up to 12 months
|
18.2%
2/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
|
Investigations
Platelet count decreased
|
28.6%
4/14 • Up to 12 months
|
36.4%
4/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
21.4%
3/14 • Up to 12 months
|
18.2%
2/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/14 • Up to 12 months
|
27.3%
3/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.1%
1/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/14 • Up to 12 months
|
18.2%
2/11 • Up to 12 months
|
25.0%
1/4 • Up to 12 months
|
42.9%
3/7 • Up to 12 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
|
Eye disorders
Retinal detachment
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
14.3%
2/14 • Up to 12 months
|
36.4%
4/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
25.0%
1/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/14 • Up to 12 months
|
18.2%
2/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Nervous system disorders
Somnolence
|
7.1%
1/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Vascular disorders
Thromboembolic event
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Infections and infestations
Tooth infection
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Infections and infestations
Upper respiratory infection
|
21.4%
3/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Renal and urinary disorders
Urinary frequency
|
7.1%
1/14 • Up to 12 months
|
27.3%
3/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
|
Renal and urinary disorders
Urinary urgency
|
7.1%
1/14 • Up to 12 months
|
18.2%
2/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
14.3%
1/7 • Up to 12 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Eye disorders
Watering eyes
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Investigations
Weight gain
|
7.1%
1/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Investigations
Weight loss
|
7.1%
1/14 • Up to 12 months
|
18.2%
2/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/14 • Up to 12 months
|
9.1%
1/11 • Up to 12 months
|
0.00%
0/4 • Up to 12 months
|
0.00%
0/7 • Up to 12 months
|
|
Investigations
White blood cell decreased
|
35.7%
5/14 • Up to 12 months
|
0.00%
0/11 • Up to 12 months
|
25.0%
1/4 • Up to 12 months
|
28.6%
2/7 • Up to 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place