Trial Outcomes & Findings for Prophylactic White Cell Transfusions Versus Therapeutic White Cell Transfusions in Patients With Leukemia (NCT NCT01204788)
NCT ID: NCT01204788
Last Updated: 2015-06-10
Results Overview
Primary outcome is infection (yes/no) where participant without infection found by day 42 patient are counted as 'No' to infection.
TERMINATED
PHASE2
5 participants
Blood draw 2-3 times a week while hospitalized, weekly thereafter. Participant to remain on study 42 days after transfusion.
2015-06-10
Participant Flow
Recruitment Period: September 15, 2010 to January 2, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
One participant was not treated and is therefore excluded from the trial.
Participant milestones
| Measure |
Arm 1 (Prophylactic Arm)
Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
|
Arm 2 (Therapeutic Arm)
Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prophylactic White Cell Transfusions Versus Therapeutic White Cell Transfusions in Patients With Leukemia
Baseline characteristics by cohort
| Measure |
Arm 1 (Prophylactic Arm)
n=1 Participants
Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
|
Arm 2 (Therapeutic Arm)
n=3 Participants
Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
|
Total
n=4 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
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood draw 2-3 times a week while hospitalized, weekly thereafter. Participant to remain on study 42 days after transfusion.Population: Outcomes inevaluable due to low recruitment.
Primary outcome is infection (yes/no) where participant without infection found by day 42 patient are counted as 'No' to infection.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1 (Prophylactic Arm)
Arm 2 (Therapeutic Arm)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Emil Freireich, MD, Professor, Department of Medical Education
University of Texas (UT) MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place