Trial Outcomes & Findings for UCB Transplant for Hematological Diseases Using a Non Myeloablative Prep (NCT NCT02722668)
NCT ID: NCT02722668
Last Updated: 2025-07-04
Results Overview
Simple proportions will be used to estimate the probability of grade II-IV actue GVHD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Day 100
Results posted on
2025-07-04
Participant Flow
Participant milestones
| Measure |
No Anti-thymocyte Globulin (ATG)
Hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycles of multi-agent chemotherapy within the 3 months previous to umbilical cord blood transplantation.
|
Anti-thymocyte Globulin (ATG)
Hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplantation, should receive Anti-thymocyte Globulin (ATG) as part of their conditioning regimen.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
10
|
|
Overall Study
COMPLETED
|
5
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
UCB Transplant for Hematological Diseases Using a Non Myeloablative Prep
Baseline characteristics by cohort
| Measure |
No Anti-thymocyte Globulin (ATG)
n=5 Participants
Hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycles of multi-agent chemotherapy within the 3 months previous to umbilical cord blood transplantation.
|
Anti-thymocyte Globulin (ATG)
n=10 Participants
Hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplantation, should receive Anti-thymocyte Globulin (ATG) as part of their conditioning regimen.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 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
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 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
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
10 participants
n=107 Participants
|
15 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 100Simple proportions will be used to estimate the probability of grade II-IV actue GVHD.
Outcome measures
| Measure |
No Anti-thymocyte Globulin (ATG)
n=5 Participants
Hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycles of multi-agent chemotherapy within the 3 months previous to umbilical cord blood transplantation.
|
Anti-thymocyte Globulin (ATG)
n=10 Participants
Hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplantation, should receive Anti-thymocyte Globulin (ATG) as part of their conditioning regimen.
|
|---|---|---|
|
Probability of Acute Graft Versus Host Disease (GVHD)
|
0 Percent of participants
Interval 0.0 to 100.0
|
30 Percent of participants
Interval 3.0 to 57.0
|
SECONDARY outcome
Timeframe: Day 100Percentage of patients with grade III-IV acute GVHD.
Outcome measures
| Measure |
No Anti-thymocyte Globulin (ATG)
n=5 Participants
Hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycles of multi-agent chemotherapy within the 3 months previous to umbilical cord blood transplantation.
|
Anti-thymocyte Globulin (ATG)
n=10 Participants
Hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplantation, should receive Anti-thymocyte Globulin (ATG) as part of their conditioning regimen.
|
|---|---|---|
|
Incidence of Acute GVHD
|
0 Percent of participants
Interval 0.0 to 100.0
|
10 Percent of participants
Interval 0.0 to 28.0
|
SECONDARY outcome
Timeframe: 6 months post transplantOutcome measures
| Measure |
No Anti-thymocyte Globulin (ATG)
n=5 Participants
Hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycles of multi-agent chemotherapy within the 3 months previous to umbilical cord blood transplantation.
|
Anti-thymocyte Globulin (ATG)
n=10 Participants
Hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplantation, should receive Anti-thymocyte Globulin (ATG) as part of their conditioning regimen.
|
|---|---|---|
|
Transplant Related Mortality
|
20 Percent of participants
Interval 0.0 to 50.0
|
20 Percent of participants
Interval 0.0 to 44.0
|
SECONDARY outcome
Timeframe: Day 21Percentage of subjects with donor chimerism.
Outcome measures
| Measure |
No Anti-thymocyte Globulin (ATG)
n=5 Participants
Hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycles of multi-agent chemotherapy within the 3 months previous to umbilical cord blood transplantation.
|
Anti-thymocyte Globulin (ATG)
n=10 Participants
Hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplantation, should receive Anti-thymocyte Globulin (ATG) as part of their conditioning regimen.
|
|---|---|---|
|
Chimerism
|
64 Percentage of participants
Interval 0.0 to 81.0
|
89 Percentage of participants
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 100Percentage of subjects with donor chimerism.
Outcome measures
| Measure |
No Anti-thymocyte Globulin (ATG)
n=5 Participants
Hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycles of multi-agent chemotherapy within the 3 months previous to umbilical cord blood transplantation.
|
Anti-thymocyte Globulin (ATG)
n=8 Participants
Hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplantation, should receive Anti-thymocyte Globulin (ATG) as part of their conditioning regimen.
|
|---|---|---|
|
Chimerism
|
100 Percentage of participants
Interval 0.0 to 100.0
|
100 Percentage of participants
Interval 70.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 180Percentage of subjects with donor chimerism.
Outcome measures
| Measure |
No Anti-thymocyte Globulin (ATG)
n=4 Participants
Hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycles of multi-agent chemotherapy within the 3 months previous to umbilical cord blood transplantation.
|
Anti-thymocyte Globulin (ATG)
n=8 Participants
Hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplantation, should receive Anti-thymocyte Globulin (ATG) as part of their conditioning regimen.
|
|---|---|---|
|
Chimerism
|
43 Percentage of participants
Interval 0.0 to 100.0
|
100 Percentage of participants
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 1 year post transplantPercentage of subjects with donor chimerism.
Outcome measures
| Measure |
No Anti-thymocyte Globulin (ATG)
n=3 Participants
Hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycles of multi-agent chemotherapy within the 3 months previous to umbilical cord blood transplantation.
|
Anti-thymocyte Globulin (ATG)
n=8 Participants
Hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplantation, should receive Anti-thymocyte Globulin (ATG) as part of their conditioning regimen.
|
|---|---|---|
|
Chimerism
|
20 Percentage of participants
Interval 0.0 to 100.0
|
100 Percentage of participants
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 42Percentage of subjects with neutrophil engraftment.
Outcome measures
| Measure |
No Anti-thymocyte Globulin (ATG)
n=5 Participants
Hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycles of multi-agent chemotherapy within the 3 months previous to umbilical cord blood transplantation.
|
Anti-thymocyte Globulin (ATG)
n=10 Participants
Hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplantation, should receive Anti-thymocyte Globulin (ATG) as part of their conditioning regimen.
|
|---|---|---|
|
Neutrophil Engraftment
|
80 Percentage of participants
Interval 42.0 to 99.0
|
90 Percentage of participants
Interval 64.0 to 99.0
|
Adverse Events
No Anti-thymocyte Globulin (ATG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Anti-thymocyte Globulin (ATG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Margaret MacMillan
University of Minnesota, Masonic Cancer Center
Phone: 612-626-2961
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place