Trial Outcomes & Findings for S0125, Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia (NCT NCT00053014)

Results Overview

measured from date of registration to study until death from any cause with patients still alive censored at date of last contact

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

1 year

Results posted on

2015-03-25

Participant milestones
Measure	Treatment patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Withdrawal data not reported

S0125, Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia

Baseline characteristics by cohort
Measure	Treatment n=5 Participants patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

Timeframe: 1 year

measured from date of registration to study until death from any cause with patients still alive censored at date of last contact

Outcome measures
Measure	Treatment n=5 Participants patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
Overall Survival	1 participants

Timeframe: 9 months

Population: All patients

Twice a week for the first two months, one time a week during month 3, one time every two weeks for months 4-9.

Outcome measures
Measure	Treatment n=5 Participants patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
Serious Adverse Events	0 participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Treatment n=5 participants at risk patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
Respiratory, thoracic and mediastinal disorders Infection and dyspnea	20.0% 1/5 • Number of events 1

SWOG statistical office

Phone: 206-667-4408