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

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ClinicalTrials.gov Identifier: NCT02203578
Recruitment Status : Terminated (slow accrual)
First Posted : July 30, 2014
Results First Posted : March 30, 2017
Last Update Posted : March 30, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Graft Versus Host Disease
Interventions Drug: romidepsin
Other: laboratory biomarker analysis
Enrollment 1
Recruitment Details 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.
Pre-assignment Details We are reporting results on 1 eligible participant.
Arm/Group Title Supportive Care (Romidepsin)
Hide Arm/Group Description

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

Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Supportive Care (Romidepsin)
Hide Arm/Group Description

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 Number of Baseline Participants 1
Hide Baseline Analysis Population Description
Participants > 18 years old with steroid (or IST) refractory aGVHD or cGVHD were enrolled.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants
49
(49 to 49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
 100.0%
1.Primary Outcome
Title Incidence of aGVHD
Hide Description [Not Specified]
Time Frame At 28 days after initiation of romidepsin
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.
Arm/Group Title Supportive Care (Romidepsin)
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Incidence of cGVHD
Hide Description [Not Specified]
Time Frame At 1 month after initiation of romidepsin
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.
Arm/Group Title Supportive Care (Romidepsin)
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Incidence of cGVHD
Hide Description [Not Specified]
Time Frame At 3 months after initiation of romidepsin
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.
Arm/Group Title Supportive Care (Romidepsin)
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Incidence of cGVHD
Hide Description [Not Specified]
Time Frame At 6 months after initiation of romidepsin
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.
Arm/Group Title Supportive Care (Romidepsin)
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Primary Outcome
Title Incidence of cGVHD
Hide Description [Not Specified]
Time Frame At 9 months after initiation of romidepsin
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.
Arm/Group Title Supportive Care (Romidepsin)
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Primary Outcome
Title Incidence of cGVHD
Hide Description [Not Specified]
Time Frame At 12 months after initiation of romidepsin
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.
Arm/Group Title Supportive Care (Romidepsin)
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Total Duration of Immunosuppressive Therapy
Hide Description [Not Specified]
Time Frame Up to 12 months after initiation of romidepsin
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.
Arm/Group Title Supportive Care (Romidepsin)
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Rate of Documented Infection
Hide Description [Not Specified]
Time Frame Up to 12 months after initiation of romidepsin
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.
Arm/Group Title Supportive Care (Romidepsin)
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title T Cell Kinetics - Reconstitution
Hide Description [Not Specified]
Time Frame Up to 12 months after initiation of romidepsin
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.
Arm/Group Title Supportive Care (Romidepsin)
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data was collected over 60 days.
Adverse Event Reporting Description CTCAE version 4.0 was utilized.
 
Arm/Group Title Supportive Care (Romidepsin)
Hide Arm/Group Description

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

All-Cause Mortality
Supportive Care (Romidepsin)
Affected / at Risk (%)
Total   0/1 (0.00%)    
Hide Serious Adverse Events
Supportive Care (Romidepsin)
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Infections and infestations   
Endocarditis infective  1/1 (100.00%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Supportive Care (Romidepsin)
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Gastrointestinal disorders   
Nausea  1/1 (100.00%)  1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roger Strair, MD, PhD
Organization: Rutgers Cancer Institute of New Jersey
Phone: 732-235-7298
EMail: strairrk@cinj.rutgers.edu
Layout table for additonal information
Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02203578    
Other Study ID Numbers: 021309
NCI-2014-01411 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
021309 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
P30CA072720 ( U.S. NIH Grant/Contract )
Pro2014004116 ( Other Identifier: IRB number )
First Submitted: July 28, 2014
First Posted: July 30, 2014
Results First Submitted: February 13, 2017
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017