Trial Outcomes & Findings for Low-Dose Total Lymphoid Irradiation in Treating Patients With Refractory Chronic Graft-versus-Host Disease After Donor Stem Cell Transplant (NCT NCT02109809)
NCT ID: NCT02109809
Last Updated: 2018-11-23
Results Overview
Toxicities (grade 2 and higher) will be reported as number of occurrences.
TERMINATED
NA
4 participants
At day 180
2018-11-23
Participant Flow
Participant milestones
| Measure |
Supportive Care (TLI)
Patients undergo LD-TLI daily for 1-2 days.
total nodal irradiation: Undergo TLI
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low-Dose Total Lymphoid Irradiation in Treating Patients With Refractory Chronic Graft-versus-Host Disease After Donor Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Supportive Care (TLI)
n=4 Participants
Patients undergo LD-TLI daily for 1-2 days.
total nodal irradiation: Undergo TLI
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
|
|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At day 180Population: Only 1 participant on study treatment and there are concerns of patient privacy.
Toxicities (grade 2 and higher) will be reported as number of occurrences.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Time from baseline to date of last follow-up or failure event, assessed at day 180Population: Only 1 participant on study treatment and there are concerns of patient privacy.
Estimated along with 95% confidence intervals (CI). Descriptive statistics will be calculated and presented for GvHD summary scores by dose level and visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Only 1 participant on study treatment and there are concerns of patient privacy.
T, natural killer (NK)T, regulatory T cell (Treg), B, NK, dendritic cell (DC) cell subsets, cell activation status and functional potential through cytokine and chemokine expression will be identified. Descriptive statistics (with 95% confidence intervals) will be calculated at each assessment time point.
Outcome measures
Outcome data not reported
Adverse Events
Supportive Care (TLI)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Gordon Phillips
Wake Forest University Health Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place