Trial Outcomes & Findings for Enhancing Anti--Tetanus Vaccine Response After Autologous Stem Cell Transplantation (NCT NCT02700841)
NCT ID: NCT02700841
Last Updated: 2024-03-12
Results Overview
Determine safety of outcomes based on the number of safely treated participants by CTCAE version 5.0 tool
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Through 180 days post-transplant
Results posted on
2024-03-12
Participant Flow
Participant milestones
| Measure |
Arm I (Vaccine, CD34 Transplant, DLI)
ARM I: Patients receive 3 doses of tetanus before transplant and on days 15, and 60 post transplant.
Melphalan: Given IV
Peripheral Blood Stem Cell Transplantation--CD34 HSCT: Undergo autologous CD34 HSCT
Peripheral Blood Stem Cell Transplantation--AHSCT: Undergo AHSCT
T Cell-Depleted Hematopoietic Stem Cell Transplantation: Undergo autologous CD34 HSCT
Tetanus Toxoid Vaccine: Given IM
|
Arm II (Vaccine, Stem Cell Transplant)
Patients receive 3 doses of tetanus as in Arm I. Patients receive high-dose melphalan IV on day -2 and undergo AHSCT on day 0.
Melphalan: Given IV
Peripheral Blood Stem Cell Transplantation--AHSCT: Undergo AHSCT
Tetanus Toxoid Vaccine: Given IM
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enhancing Anti--Tetanus Vaccine Response After Autologous Stem Cell Transplantation
Baseline characteristics by cohort
| Measure |
Arm I (Vaccine, CD34 Transplant, DLI)
n=4 Participants
ARM I: Patients receive 3 doses of tetanus before transplant and on days 15, and 60 post transplant.
Melphalan: Given IV
Peripheral Blood Stem Cell Transplantation--CD34 HSCT: Undergo autologous CD34 HSCT
Peripheral Blood Stem Cell Transplantation--AHSCT: Undergo AHSCT
T Cell-Depleted Hematopoietic Stem Cell Transplantation: Undergo autologous CD34 HSCT
Tetanus Toxoid Vaccine: Given IM
|
Arm II (Vaccine, Stem Cell Transplant)
n=4 Participants
Patients receive 3 doses of tetanus as in Arm I. Patients receive high-dose melphalan IV on day -2 and undergo AHSCT on day 0.
Melphalan: Given IV
Peripheral Blood Stem Cell Transplantation--AHSCT: Undergo AHSCT
Tetanus Toxoid Vaccine: Given IM
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 4.8 • n=99 Participants
|
66.8 years
STANDARD_DEVIATION 1.7 • n=107 Participants
|
64.1 years
STANDARD_DEVIATION 4.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
8 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through 180 days post-transplantDetermine safety of outcomes based on the number of safely treated participants by CTCAE version 5.0 tool
Outcome measures
| Measure |
Arm I (Vaccine, CD34 Transplant, DLI)
n=4 Participants
ARM I: Patients receive 3 doses of tetanus before transplant and on days 15, and 60 post transplant.
Melphalan: Given IV
Peripheral Blood Stem Cell Transplantation--CD34 HSCT: Undergo autologous CD34 HSCT
Peripheral Blood Stem Cell Transplantation--AHSCT: Undergo AHSCT
T Cell-Depleted Hematopoietic Stem Cell Transplantation: Undergo autologous CD34 HSCT
Tetanus Toxoid Vaccine: Given IM
|
Arm II (Vaccine, Stem Cell Transplant)
n=4 Participants
Patients receive 3 doses of tetanus as in Arm I. Patients receive high-dose melphalan IV on day -2 and undergo AHSCT on day 0.
Melphalan: Given IV
Peripheral Blood Stem Cell Transplantation--AHSCT: Undergo AHSCT
Tetanus Toxoid Vaccine: Given IM
|
|---|---|---|
|
Number of Safely Treated Participants (Feasibility and Safety)
|
4 Participants
|
4 Participants
|
Adverse Events
Arm I (Vaccine, CD34 Transplant, DLI)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm II (Vaccine, Stem Cell Transplant)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Vaccine, CD34 Transplant, DLI)
n=4 participants at risk
ARM I: Patients receive 3 doses of tetanus before transplant and on days 15, and 60 post transplant.
Melphalan: Given IV
Peripheral Blood Stem Cell Transplantation--CD34 HSCT: Undergo autologous CD34 HSCT
Peripheral Blood Stem Cell Transplantation--AHSCT: Undergo AHSCT
T Cell-Depleted Hematopoietic Stem Cell Transplantation: Undergo autologous CD34 HSCT
Tetanus Toxoid Vaccine: Given IM
|
Arm II (Vaccine, Stem Cell Transplant)
n=4 participants at risk
Patients receive 3 doses of tetanus as in Arm I. Patients receive high-dose melphalan IV on day -2 and undergo AHSCT on day 0.
Melphalan: Given IV
Peripheral Blood Stem Cell Transplantation--AHSCT: Undergo AHSCT
Tetanus Toxoid Vaccine: Given IM
|
|---|---|---|
|
Investigations
white blood cell decreased
|
100.0%
4/4 • Number of events 12 • Adverse Event Data was collected from the start of any protocol intervention to day 180 post transplant.
|
100.0%
4/4 • Number of events 12 • Adverse Event Data was collected from the start of any protocol intervention to day 180 post transplant.
|
|
Investigations
Lymphocyte Count Decreased
|
50.0%
2/4 • Number of events 6 • Adverse Event Data was collected from the start of any protocol intervention to day 180 post transplant.
|
75.0%
3/4 • Number of events 8 • Adverse Event Data was collected from the start of any protocol intervention to day 180 post transplant.
|
|
Investigations
Neutrophil Count Decreased
|
25.0%
1/4 • Number of events 2 • Adverse Event Data was collected from the start of any protocol intervention to day 180 post transplant.
|
75.0%
3/4 • Number of events 5 • Adverse Event Data was collected from the start of any protocol intervention to day 180 post transplant.
|
|
Investigations
Platelet Count Decreased
|
100.0%
4/4 • Number of events 11 • Adverse Event Data was collected from the start of any protocol intervention to day 180 post transplant.
|
50.0%
2/4 • Number of events 5 • Adverse Event Data was collected from the start of any protocol intervention to day 180 post transplant.
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/4 • Adverse Event Data was collected from the start of any protocol intervention to day 180 post transplant.
|
25.0%
1/4 • Number of events 1 • Adverse Event Data was collected from the start of any protocol intervention to day 180 post transplant.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • Adverse Event Data was collected from the start of any protocol intervention to day 180 post transplant.
|
25.0%
1/4 • Number of events 1 • Adverse Event Data was collected from the start of any protocol intervention to day 180 post transplant.
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • Number of events 1 • Adverse Event Data was collected from the start of any protocol intervention to day 180 post transplant.
|
0.00%
0/4 • Adverse Event Data was collected from the start of any protocol intervention to day 180 post transplant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place