Trial Outcomes & Findings for A Study for Leukemia Patients With Life-Threatening Infections (NCT NCT00968838)

Results Overview

Participant survival measured over the 30 days subsequent to the first granulocyte transfusion. Collecting complete blood counts (CBCs) pre and post transfusion allows determination of whether the duration of neutrophil replacement differs between the two study groups (comparing unradiated white blood cells to radiated white blood cell infusion).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

178 participants

Primary outcome timeframe

30 Days

Results posted on

2013-11-26

Participant Flow

Recruitment Period: 07/16/2008 through 7/14/2011. All participants recruited at The University of Texas (UT) MD Anderson Cancer Center.

Of 178 participants registered, there were 108 participants included in the study and analysis. The 70 participants excluded were ineligible or unable to be matched with a transfusion donor.

Participant milestones

Participant milestones
Measure	Non-radiated White Blood Cell Transfusion Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.	White Blood Cell Transfusion Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
Overall Study STARTED	50	58
Overall Study COMPLETED	50	58
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study for Leukemia Patients With Life-Threatening Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-radiated White Blood Cell Transfusion n=50 Participants Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.	White Blood Cell Transfusion n=58 Participants Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.	Total n=108 Participants Total of all reporting groups
Age Continuous	57.5 Years n=5 Participants	60 Years n=7 Participants	59 Years n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	33 Participants n=7 Participants	57 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	58 participants n=7 Participants	108 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 Days

Participant survival measured over the 30 days subsequent to the first granulocyte transfusion. Collecting complete blood counts (CBCs) pre and post transfusion allows determination of whether the duration of neutrophil replacement differs between the two study groups (comparing unradiated white blood cells to radiated white blood cell infusion).

Outcome measures

Outcome measures
Measure	Non-radiated White Blood Cell Transfusion n=50 Participants Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.	White Blood Cell Transfusion n=58 Participants Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
Number of Participants Alive at Day 30	31 Participants	39 Participants

Adverse Events

Non-radiated White Blood Cell Transfusion

Serious events: 5 serious events

Other events: 3 other events

Deaths: 0 deaths

White Blood Cell Transfusion

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Non-radiated White Blood Cell Transfusion n=50 participants at risk Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.	White Blood Cell Transfusion n=58 participants at risk Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
Infections and infestations Infection	8.0% 4/50 • Number of events 4 • Participants followed from baseline to minimally 30 days post transfusion(s). Adverse event data collection for all participants was over a study period of 3 years.	3.4% 2/58 • Number of events 2 • Participants followed from baseline to minimally 30 days post transfusion(s). Adverse event data collection for all participants was over a study period of 3 years.
General disorders Disease Progression	2.0% 1/50 • Number of events 1 • Participants followed from baseline to minimally 30 days post transfusion(s). Adverse event data collection for all participants was over a study period of 3 years.	1.7% 1/58 • Number of events 1 • Participants followed from baseline to minimally 30 days post transfusion(s). Adverse event data collection for all participants was over a study period of 3 years.

Other adverse events

Other adverse events
Measure	Non-radiated White Blood Cell Transfusion n=50 participants at risk Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.	White Blood Cell Transfusion n=58 participants at risk Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
Respiratory, thoracic and mediastinal disorders Shortness of Breath	6.0% 3/50 • Number of events 3 • Participants followed from baseline to minimally 30 days post transfusion(s). Adverse event data collection for all participants was over a study period of 3 years.	3.4% 2/58 • Number of events 2 • Participants followed from baseline to minimally 30 days post transfusion(s). Adverse event data collection for all participants was over a study period of 3 years.

Additional Information

Dr. Emil J. Freireich MD/Professor

The University of Texas M D Anderson Cancer Center

Phone: 713-792-2660

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place