Trial Outcomes & Findings for Donor Peripheral Stem Cell Transplant and Donor Natural Killer Cell Transplant After Total-Body Irradiation, Thiotepa, Fludarabine, and Muromonab-CD3 in Treating Patients With Leukemia or Other Blood Diseases (NCT NCT00450983)

Results Overview

Count of participants with acute GVHD grades III-IV.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Up to day 100

Results posted on

2017-05-24

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Donor Peripheral Stem Cell Transplant and Donor Natural Killer Cell Transplant After Total-Body Irradiation, Thiotepa, Fludarabine, and Muromonab-CD3 in Treating Patients With Leukemia or Other Blood Diseases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=1 Participants Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
Age, Continuous	1.7 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to day 100

Count of participants with acute GVHD grades III-IV.

Outcome measures

Outcome measures
Measure	Treatment n=1 Participants Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
Risk of Developing Grades III-IV Acute Graft-vs-host Disease (GVHD)	0 Participants

SECONDARY outcome

Timeframe: Up to day 180

Count of participant deaths from infection up to day 180.

Outcome measures

Outcome measures
Measure	Treatment n=1 Participants Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
Risk for Mortality From Infection Before Day 180	0 Participants

SECONDARY outcome

Timeframe: Engraftment documented day +20

Count of participant that had graft failure.

Outcome measures

Outcome measures
Measure	Treatment n=1 Participants Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
Risk for Graft Failure	0 Participants

SECONDARY outcome

Timeframe: Up to day 100

Count of participants with life-threatening infections