Trial Outcomes & Findings for Romidepsin in Treating Patients With Steroid-Refractory Graft-versus-Host Disease (NCT NCT02203578)

NCT ID: NCT02203578

Last Updated: 2017-03-30

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1 participants
• Primary outcome timeframe: At 28 days after initiation of romidepsin
• Results posted on: 2017-03-30

Participant Flow

Subjects were recruited through the Rutgers Cancer Institute of New Jersey. The study was open to accrual on 11/20/2014 and was closed by the Principal Investigator on 6/14/2016 due to slow accrual.

We are reporting results on 1 eligible participant.

Participant milestones

Measure	Supportive Care (Romidepsin) Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV laboratory biomarker analysis: Correlative studies
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Romidepsin in Treating Patients With Steroid-Refractory Graft-versus-Host Disease

Baseline characteristics by cohort

Measure	Supportive Care (Romidepsin) n=1 Participants Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV laboratory biomarker analysis: Correlative studies
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
Age, Continuous	49 years 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: At 28 days after initiation of romidepsin

Population: Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.

Outcome measures

Measure	Supportive Care (Romidepsin) Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV laboratory biomarker analysis: Correlative studies
Incidence of aGVHD	0

PRIMARY outcome

Timeframe: At 1 month after initiation of romidepsin

Population: Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.

Outcome measures

Measure	Supportive Care (Romidepsin) Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV laboratory biomarker analysis: Correlative studies
Incidence of cGVHD	0

PRIMARY outcome

Timeframe: At 3 months after initiation of romidepsin

Population: Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.

Outcome measures

Measure	Supportive Care (Romidepsin) Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV laboratory biomarker analysis: Correlative studies
Incidence of cGVHD	0

PRIMARY outcome

Timeframe: At 6 months after initiation of romidepsin

Population: Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.

Outcome measures

Measure	Supportive Care (Romidepsin) Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV laboratory biomarker analysis: Correlative studies
Incidence of cGVHD	0

PRIMARY outcome

Timeframe: At 9 months after initiation of romidepsin

Population: Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.

Outcome measures

Measure	Supportive Care (Romidepsin) Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV laboratory biomarker analysis: Correlative studies
Incidence of cGVHD	0

PRIMARY outcome

Timeframe: At 12 months after initiation of romidepsin

Population: Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.

Outcome measures

Measure	Supportive Care (Romidepsin) Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV laboratory biomarker analysis: Correlative studies
Incidence of cGVHD	0

SECONDARY outcome

Timeframe: Up to 12 months after initiation of romidepsin

Population: Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.

Outcome measures

Measure	Supportive Care (Romidepsin) Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV laboratory biomarker analysis: Correlative studies
Total Duration of Immunosuppressive Therapy	0

SECONDARY outcome

Timeframe: Up to 12 months after initiation of romidepsin

Population: Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.

Outcome measures

Measure	Supportive Care (Romidepsin) Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV laboratory biomarker analysis: Correlative studies
Rate of Documented Infection	0

SECONDARY outcome

Timeframe: Up to 12 months after initiation of romidepsin

Population: Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.

Outcome measures

Measure	Supportive Care (Romidepsin) Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV laboratory biomarker analysis: Correlative studies
T Cell Kinetics - Reconstitution	0

Adverse Events

Supportive Care (Romidepsin)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Supportive Care (Romidepsin) n=1 participants at risk Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV laboratory biomarker analysis: Correlative studies
Infections and infestations Endocarditis infective	100.0% 1/1 • Number of events 1 • Adverse event data was collected over 60 days. CTCAE version 4.0 was utilized.

Other adverse events

Measure	Supportive Care (Romidepsin) n=1 participants at risk Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV laboratory biomarker analysis: Correlative studies
Gastrointestinal disorders Nausea	100.0% 1/1 • Number of events 1 • Adverse event data was collected over 60 days. CTCAE version 4.0 was utilized.

Additional Information

Roger Strair, MD, PhD

Rutgers Cancer Institute of New Jersey

Phone: 732-235-7298

Email: strairrk@cinj.rutgers.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place