Trial Outcomes & Findings for Flu,Alemtuzumab,and TBI Followed By Donor Stem Cell Chronic Phase CML (NCT NCT00416884)

Results Overview

Treatment related mortality is a consequence of both complications of the preparative regimen and systemic immunological rejection which is manifested as graft versus host disease(GVHD). The preparative regimens which include whole body radiation and/or high dose chemotherapy are complicated by single or multi-organ failure and by prolonged myelosuppression that can lead to infections and bleeding

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

lifetime followup, up to 100 years.

Results posted on

2017-09-27

Participant Flow

Participant milestones

Participant milestones
Measure	TBI, Campath, Fludarabine T-cell Deplete (Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	TBI, Campath, Fludarabine T-cell Deplete (Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
Overall Study Study terminated due to low accrual	1

Baseline Characteristics

Flu,Alemtuzumab,and TBI Followed By Donor Stem Cell Chronic Phase CML

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TBI, Campath, Fludarabine T-cell Deplete n=1 Participants (Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: lifetime followup, up to 100 years.

Treatment related mortality is a consequence of both complications of the preparative regimen and systemic immunological rejection which is manifested as graft versus host disease(GVHD). The preparative regimens which include whole body radiation and/or high dose chemotherapy are complicated by single or multi-organ failure and by prolonged myelosuppression that can lead to infections and bleeding

Outcome measures

Outcome measures
Measure	TBI, Campath, Fludarabine T-cell Deplete n=1 Participants (Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
Number of Participants With Treatment-related Mortality	0 Participants

Adverse Events

TBI, Campath, Fludarabine T-cell Deplete

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Center for Hematologic Malignancies

Phone: 503-494-1551

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place