Trial Outcomes & Findings for Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies (NCT NCT00988013)
NCT ID: NCT00988013
Last Updated: 2021-06-14
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
1 year post-transplant
Results posted on
2021-06-14
Participant Flow
Participant milestones
| Measure |
IM-TMI (3Gy)
Patients will receive 3Gy per day for 1 day (total of 3Gy).
IM-TMI (3Gy): Patients will receive 3Gy per day for 1 day.
|
IM-TMI (6Gy)
Patients will receive 3Gy per day for 2 days (for a total of 6Gy).
IM-TMI (6Gy): Patients will receive 3Gy per day for 2 days.
|
IM-TMI (9Gy)
Patients will receive 3Gy per day for 3 days (for a total of 9Gy).
IM-TMI (9Gy): Patients will receive 3Gy per day for 3 days.
|
IM-TMI (12Gy)
Patients will receive 3Gy per day for 4 days (for a total of 12Gy).
IM-TMI (12Gy): Patients will receive 3Gy per day for 4 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
2
|
|
Overall Study
COMPLETED
|
3
|
3
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
IM-TMI (3Gy)
n=3 Participants
Patients will receive 3Gy per day for 1 day (total of 3Gy).
IM-TMI (3Gy): Patients will receive 3Gy per day for 1 day.
|
IM-TMI (6Gy)
n=3 Participants
Patients will receive 3Gy per day for 2 days (for a total of 6Gy).
IM-TMI (6Gy): Patients will receive 3Gy per day for 2 days.
|
IM-TMI (9Gy)
n=6 Participants
Patients will receive 3Gy per day for 3 days (for a total of 9Gy).
IM-TMI (9Gy): Patients will receive 3Gy per day for 3 days.
|
IM-TMI (12Gy)
n=2 Participants
Patients will receive 3Gy per day for 4 days (for a total of 12Gy).
IM-TMI (12Gy): Patients will receive 3Gy per day for 4 days.
|
Total
n=14 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Age, Categorical
>=65 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, Continuous
|
52 Years
n=5 Participants
|
38 Years
n=7 Participants
|
39 Years
n=5 Participants
|
53 Years
n=4 Participants
|
52 Years
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 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
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 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
|
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
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 year post-transplantOutcome measures
| Measure |
IM-TMI (3Gy)
n=3 Participants
Patients will receive 3Gy per day for 1 day (total of 3Gy).
IM-TMI (3Gy): Patients will receive 3Gy per day for 1 day.
|
IM-TMI (6Gy)
n=3 Participants
Patients will receive 3Gy per day for 2 days (for a total of 6Gy).
IM-TMI (6Gy): Patients will receive 3Gy per day for 2 days.
|
IM-TMI (12Gy)
n=6 Participants
Patients will receive 3Gy per day for 3 days (for a total of 12Gy).
IM-TMI (9Gy): Patients will receive 3Gy per day for 3 days.
|
IM-TMI (9Gy)
n=2 Participants
Patients will receive 3Gy per day for 4 days (for a total of 9Gy).
IM-TMI (12Gy): Patients will receive 3Gy per day for 4 days.
|
|---|---|---|---|---|
|
Number of Participants With Grade 4 TMI Toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 1 year post-transplantPopulation: Grade 4 TMI toxicity 0 Grade 4 TMI toxicity 0 Grade 4 TMI toxicity 0 Grade 4 TMI toxicity 0
Outcome measures
| Measure |
IM-TMI (3Gy)
n=3 Participants
Patients will receive 3Gy per day for 1 day (total of 3Gy).
IM-TMI (3Gy): Patients will receive 3Gy per day for 1 day.
|
IM-TMI (6Gy)
n=3 Participants
Patients will receive 3Gy per day for 2 days (for a total of 6Gy).
IM-TMI (6Gy): Patients will receive 3Gy per day for 2 days.
|
IM-TMI (12Gy)
n=6 Participants
Patients will receive 3Gy per day for 3 days (for a total of 12Gy).
IM-TMI (9Gy): Patients will receive 3Gy per day for 3 days.
|
IM-TMI (9Gy)
n=2 Participants
Patients will receive 3Gy per day for 4 days (for a total of 9Gy).
IM-TMI (12Gy): Patients will receive 3Gy per day for 4 days.
|
|---|---|---|---|---|
|
Number of Participants With 1 Year Mortality Unrelated to TMI
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 100 days post-transplantOutcome measures
| Measure |
IM-TMI (3Gy)
n=3 Participants
Patients will receive 3Gy per day for 1 day (total of 3Gy).
IM-TMI (3Gy): Patients will receive 3Gy per day for 1 day.
|
IM-TMI (6Gy)
n=3 Participants
Patients will receive 3Gy per day for 2 days (for a total of 6Gy).
IM-TMI (6Gy): Patients will receive 3Gy per day for 2 days.
|
IM-TMI (12Gy)
n=6 Participants
Patients will receive 3Gy per day for 3 days (for a total of 12Gy).
IM-TMI (9Gy): Patients will receive 3Gy per day for 3 days.
|
IM-TMI (9Gy)
n=2 Participants
Patients will receive 3Gy per day for 4 days (for a total of 9Gy).
IM-TMI (12Gy): Patients will receive 3Gy per day for 4 days.
|
|---|---|---|---|---|
|
Time to Neutrophil and Platelet Engraftment in Patients With Hematologic Malignancies
|
15 Days
Interval 10.0 to 20.0
|
15 Days
Interval 10.0 to 20.0
|
15 Days
Interval 10.0 to 20.0
|
15 Days
Interval 10.0 to 20.0
|
Adverse Events
IM-TMI (3Gy)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
IM-TMI (6Gy)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
IM-TMI (9Gy)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 4 deaths
IM-TMI (12Gy)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
IM-TMI (3Gy)
n=3 participants at risk
Patients will receive 3Gy per day for 1 day (total of 3Gy).
IM-TMI (3Gy): Patients will receive 3Gy per day for 1 day.
|
IM-TMI (6Gy)
n=3 participants at risk
Patients will receive 3Gy per day for 2 days (for a total of 6Gy).
IM-TMI (6Gy): Patients will receive 3Gy per day for 2 days.
|
IM-TMI (9Gy)
n=6 participants at risk
Patients will receive 3Gy per day for 3 days (for a total of 9Gy).
IM-TMI (9Gy): Patients will receive 3Gy per day for 3 days.
|
IM-TMI (12Gy)
n=2 participants at risk
Patients will receive 3Gy per day for 4 days (for a total of 12Gy).
IM-TMI (12Gy): Patients will receive 3Gy per day for 4 days.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
GI hemorrhage
|
0.00%
0/3 • 7 years
|
0.00%
0/3 • 7 years
|
0.00%
0/6 • 7 years
|
50.0%
1/2 • Number of events 1 • 7 years
|
|
Infections and infestations
GVHD
|
0.00%
0/3 • 7 years
|
0.00%
0/3 • 7 years
|
16.7%
1/6 • Number of events 1 • 7 years
|
0.00%
0/2 • 7 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • 7 years
|
0.00%
0/3 • 7 years
|
0.00%
0/6 • 7 years
|
50.0%
1/2 • Number of events 1 • 7 years
|
|
Hepatobiliary disorders
Liver failure
|
0.00%
0/3 • 7 years
|
0.00%
0/3 • 7 years
|
16.7%
1/6 • Number of events 1 • 7 years
|
0.00%
0/2 • 7 years
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/3 • 7 years
|
0.00%
0/3 • 7 years
|
16.7%
1/6 • Number of events 1 • 7 years
|
0.00%
0/2 • 7 years
|
Other adverse events
| Measure |
IM-TMI (3Gy)
n=3 participants at risk
Patients will receive 3Gy per day for 1 day (total of 3Gy).
IM-TMI (3Gy): Patients will receive 3Gy per day for 1 day.
|
IM-TMI (6Gy)
n=3 participants at risk
Patients will receive 3Gy per day for 2 days (for a total of 6Gy).
IM-TMI (6Gy): Patients will receive 3Gy per day for 2 days.
|
IM-TMI (9Gy)
n=6 participants at risk
Patients will receive 3Gy per day for 3 days (for a total of 9Gy).
IM-TMI (9Gy): Patients will receive 3Gy per day for 3 days.
|
IM-TMI (12Gy)
n=2 participants at risk
Patients will receive 3Gy per day for 4 days (for a total of 12Gy).
IM-TMI (12Gy): Patients will receive 3Gy per day for 4 days.
|
|---|---|---|---|---|
|
Infections and infestations
Oral mucositis
|
100.0%
3/3 • Number of events 3 • 7 years
|
100.0%
3/3 • Number of events 3 • 7 years
|
100.0%
6/6 • Number of events 6 • 7 years
|
100.0%
2/2 • Number of events 2 • 7 years
|
|
Gastrointestinal disorders
Gut mucocitis
|
0.00%
0/3 • 7 years
|
33.3%
1/3 • Number of events 1 • 7 years
|
16.7%
1/6 • Number of events 1 • 7 years
|
50.0%
1/2 • Number of events 1 • 7 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place