Trial Outcomes & Findings for Fludarabine, Cyclophosphamide, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing a Donor Umbilical Cord Blood Transplant for Hematologic Cancer (NCT NCT00255684)
NCT ID: NCT00255684
Last Updated: 2016-11-03
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
100 days
Results posted on
2016-11-03
Participant Flow
Participant milestones
| Measure |
Conditioning Therapy Followed by TBI
Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil
graft-versus-tumor prophylaxis therapy
cyclophosphamide
cyclosporine
fludarabine phosphate
mycophenolate mofetil
umbilical cord blood transplantation
radiation therapy
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fludarabine, Cyclophosphamide, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing a Donor Umbilical Cord Blood Transplant for Hematologic Cancer
Baseline characteristics by cohort
| Measure |
Conditioning Therapy Followed by TBI
n=16 Participants
Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil
graft-versus-tumor prophylaxis therapy
cyclophosphamide
cyclosporine
fludarabine phosphate
mycophenolate mofetil
umbilical cord blood transplantation
radiation therapy
|
|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 100 daysOutcome measures
| Measure |
Conditioning Therapy Followed by TBI
n=16 Participants
Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil
graft-versus-tumor prophylaxis therapy
cyclophosphamide
cyclosporine
fludarabine phosphate
mycophenolate mofetil
umbilical cord blood transplantation
radiation therapy
|
|---|---|
|
Number of Participants Who Survived 100 Days or Longer
|
13 participants
|
SECONDARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
Conditioning Therapy Followed by TBI
n=16 Participants
Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil
graft-versus-tumor prophylaxis therapy
cyclophosphamide
cyclosporine
fludarabine phosphate
mycophenolate mofetil
umbilical cord blood transplantation
radiation therapy
|
|---|---|
|
Number of Participants Who Developed Acute Graft Versus Host Disease
|
0 participants
|
Adverse Events
Conditioning Therapy Followed by TBI
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Conditioning Therapy Followed by TBI
n=16 participants at risk
Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil
graft-versus-tumor prophylaxis therapy
cyclophosphamide
cyclosporine
fludarabine phosphate
mycophenolate mofetil
umbilical cord blood transplantation
radiation therapy
|
|---|---|
|
Immune system disorders
graft versus host disease
|
18.8%
3/16
|
|
General disorders
multi-organ failure
|
12.5%
2/16
|
|
Immune system disorders
Post-transplant lymphoproliferative disorder
|
6.2%
1/16
|
|
Metabolism and nutrition disorders
Syndrome of Inappropriate Antidiuretic Hormone Secretion
|
6.2%
1/16
|
|
Infections and infestations
sepsis
|
18.8%
3/16
|
|
General disorders
relapsed transplant resulting in death
|
25.0%
4/16
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place