CompletedNCT03483675Updated Jun 23, 2021Results posted

Discontinuation or Continuation of Immunosuppressive Therapy in Participants With Chronic Graft Versus Host Disease

A Phase 2 interventional study of Immunosuppressive Therapy and Immunosuppressive Therapy in Chronic Graft Versus Host Disease, sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2021-06-23.

Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 21
Allocation: Randomized
Sex: All

Study summary

This randomized trial studies how well discontinuation or continuation of immunosuppressive therapy works in treating participants with chronic graft versus host disease. Continuation of immunosuppressive treatment may prevent graft-versus-host disease worsening.

Read the detailed description

PRIMARY OBJECTIVE:

I. Assess feasibility of enrolling and randomizing patients with chronic graft versus host disease (GVHD) to discontinuation (standard of care) versus continuation (investigation) of immunosuppressive therapy (IST).

SECONDARY OBJECTIVES:

I. Assess feasibility of enrolling and randomizing patients who are not local, and evaluate the quality of data received for those patients.

II. Assess whether prolonged IST decreases the need for pulses of high dose IST.

III. Evaluate the effect of prolonged IST on chronic GVHD manifestations and severity, risk of relapse, infection and organ toxicity.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants have their IST tapered and discontinued per the plan.

ARM II: Participants continue to receive a fixed dose IST for an additional 9 months with no taper.

After completion of study treatment, participants are followed up annually.

Conditions studied

Chronic Graft Versus Host Disease

Browse trials for

Bronchiolitis Obliterans Syndrome 389

In context

Bronchiolitis Obliterans Syndrome

389 studies on the registry are indexed under Bronchiolitis Obliterans Syndrome; 103 are open to participants now.

This study's enrollment of 21 is below the median of 35 across 307 interventional studies indexed under Bronchiolitis Obliterans Syndrome.

Browse Bronchiolitis Obliterans Syndrome studies →

Lead sponsor

Fred Hutchinson Cancer Center is the lead sponsor of 546 studies on the registry; 79 are open to participants now.

Of its 59 completed or terminated interventional studies of FDA-regulated products, 46 (78%) have results posted.

Browse Fred Hutchinson Cancer Center studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Prior first allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis
Patients who are on one systemic immunosuppressive agent for chronic GVHD with a plan to withdraw all systemic IST; hydrocortisone or prednisone continued for treatment of adrenal insufficiency is not considered a systemic IST
No evidence of malignancy at the time of enrollment
Agree to be evaluated at the transplant center or by local provider every 3 months for 12 months after randomization
Agreement to be contacted by phone or e-mail for health status evaluation for up to 3 years
Signed, informed consent

Exclusion criteria

Exclusion Criteria:

Inability to comply with study procedures
Pregancy

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 21 participants (actual)

Study arms

Active comparator
Arm I (discontinued IST)
Participants have their IST tapered and discontinued per the plan.
Biological: Immunosuppressive Therapy · Other: Survey Administration
Experimental
Arm II (continued IST)
Participants continue to receive a fixed dose IST for an additional 9 months with no taper.
Biological: Immunosuppressive Therapy · Other: Survey Administration

Interventions

BiologicalImmunosuppressive Therapy
Discontinued IST
Also known as: Anti-Rejection Therapy, immunosuppression
BiologicalImmunosuppressive Therapy
Continued IST
Also known as: Anti-Rejection Therapy, immunosuppression
OtherSurvey Administration
Ancillary studies

What researchers measure

Primary outcomes

Feasibility of Enrolling Patients
Descriptive summary of number of patients enrolled on the study (signed consent)
Time frame: 22.9 months

Secondary outcomes

Feasibility of Randomizing Patients
Descriptive summary of percentage of patients randomized.
Time frame: 22.9 months
Compliance With Treatment
Rate of patients following study immunosuppressive therapy management based on study arm (standard taper or continuation of low dose).
Time frame: Up to 12 months after randomization
Compliance With Data Collection
Count of surveys completed by physicians and patients
Time frame: Up to 12 months after randomization
Graft Versus Host Disease Manifestations
New chronic graft versus host disease (GVHD) manifestations and/or worsening of existing manifestations
Time frame: Up to 12 months after randomization
Recurrent Malignancy
Incidence of relapse of primary disease
Time frame: Up to 12 months after randomization
Incidence of Grade >= 3 Infections
Incidence of grade \>= 3 infections
Time frame: Up to 12 months after randomization
Incidence of Grade >= 3 Organ Toxicity
Incidence of grade \>= 3 organ toxicity
Time frame: Up to 12 months after randomization
Enrollment Rate of Participants Who Are Not Local
Enrollment rate of participants who are not local. Participants who are local defined as those who had all or some study visits completed at the cancer center.
Time frame: Up to 12 months after randomization
Quality of Data of Participants Who Are Not Local
Participants who are local defined as those who had all or some study visits completed at the cancer center.
Time frame: Up to 12 months after randomization

Results

Posted Jun 23, 2021

Participant flow

Participant flow — Overall Study
Milestone	Arm I (Discontinued IST)	Arm II (Continued IST)
Started	9	8
Completed	9	8
Not completed	0	0

Outcome measures

PrimaryFeasibility of Enrolling Patients

Descriptive summary of number of patients enrolled on the study (signed consent)

Time frame:: 22.9 months
Reported as:: Count of participants · Participants

Feasibility of Enrolling Patients
Participants	Total Number of Participants
Feasibility of Enrolling Patients	21

SecondaryFeasibility of Randomizing Patients

Descriptive summary of percentage of patients randomized.

Time frame:: 22.9 months
Reported as:: Count of participants · Participants

Feasibility of Randomizing Patients
Participants	Total Number of Participants
Feasibility of Randomizing Patients	17

SecondaryCompliance With Treatment

Rate of patients following study immunosuppressive therapy management based on study arm (standard taper or continuation of low dose).

Time frame:: Up to 12 months after randomization
Reported as:: Count of participants · Participants

Compliance With Treatment
Participants	Arm I (Discontinued IST)	Arm II (Continued IST)
Compliance With Treatment	7	8

SecondaryCompliance With Data Collection

Count of surveys completed by physicians and patients

Time frame:: Up to 12 months after randomization
Reported as:: Number · surveys

Compliance With Data Collection
surveys	Arm I (Discontinued IST)	Arm II (Continued IST)
Total surveys collected	48	39
Patient surveys missed	3	4
Physician surveys missed	5	6

SecondaryGraft Versus Host Disease Manifestations

New chronic graft versus host disease (GVHD) manifestations and/or worsening of existing manifestations

Time frame:: Up to 12 months after randomization
Reported as:: Count of participants · Participants

Graft Versus Host Disease Manifestations
Participants	Arm I (Discontinued IST)	Arm II (Continued IST)
Graft Versus Host Disease Manifestations	2	0

SecondaryRecurrent Malignancy

Incidence of relapse of primary disease

Time frame:: Up to 12 months after randomization
Reported as:: Count of participants · Participants

Recurrent Malignancy
Participants	Arm I (Discontinued IST)	Arm II (Continued IST)
Recurrent Malignancy	0	0

SecondaryIncidence of Grade >= 3 Infections

Incidence of grade \>= 3 infections

Time frame:: Up to 12 months after randomization
Reported as:: Count of participants · Participants

Incidence of Grade >= 3 Infections
Participants	Arm I (Discontinued IST)	Arm II (Continued IST)
Incidence of Grade >= 3 Infections	1	0

SecondaryIncidence of Grade >= 3 Organ Toxicity

Incidence of grade \>= 3 organ toxicity

Time frame:: Up to 12 months after randomization
Reported as:: Count of participants · Participants

Incidence of Grade >= 3 Organ Toxicity
Participants	Arm I (Discontinued IST)	Arm II (Continued IST)
Incidence of Grade >= 3 Organ Toxicity	0	0

SecondaryEnrollment Rate of Participants Who Are Not Local

Enrollment rate of participants who are not local. Participants who are local defined as those who had all or some study visits completed at the cancer center.

Time frame:: Up to 12 months after randomization

No measurements were reported for this outcome.

SecondaryQuality of Data of Participants Who Are Not Local

Participants who are local defined as those who had all or some study visits completed at the cancer center.

Time frame:: Up to 12 months after randomization

No measurements were reported for this outcome.

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Arm I (Discontinued IST)	0/9 (0%)	0/9 (0%)	8/9 (88.9%)
Arm II (Continued IST)	0/8 (0%)	2/8 (25%)	6/8 (75%)

Most frequent serious events

Most frequent serious events
Event	Arm I (Discontinued IST)	Arm II (Continued IST)
GangreneInfections and infestations	0/9	1/8
heart failureCardiac disorders	0/9	1/8
myocardial infarctionCardiac disorders	0/9	1/8
osteomyelitisInfections and infestations	0/9	1/8
peripheral ischemiaVascular disorders	0/9	1/8
retinal detachmentEye disorders	0/9	1/8
stent placementCardiac disorders	0/9	1/8
wound complicationsInfections and infestations	0/9	1/8

Most frequent other events

Showing 10 of 50

Most frequent other events
Event	Arm I (Discontinued IST)	Arm II (Continued IST)
fatigueGeneral disorders	2/2	2/8
upper respiratory infectionRespiratory, thoracic and mediastinal disorders	4/9	4/8
lower respiratory infectionRespiratory, thoracic and mediastinal disorders	4/9	1/8
myalgiaMusculoskeletal and connective tissue disorders	2/9	3/8
nauseaGastrointestinal disorders	3/9	1/8
arthralgiaMusculoskeletal and connective tissue disorders	2/9	2/8
insomniaGeneral disorders	0/9	2/8
neuropathyNervous system disorders	1/9	2/8
skin, ulcer or lesionSkin and subcutaneous tissue disorders	1/9	2/8
squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	2/9	2/8

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Arm I (Discontinued IST)	Arm II (Continued IST)	Total
<=18 years	0	0	0
Between 18 and 65 years	4	4	8
>=65 years	5	4	9

Sex: Female, Male
Sex: Female, Male(Participants)	Arm I (Discontinued IST)	Arm II (Continued IST)	Total
Female	0	0	0
Male	9	8	17

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Arm I (Discontinued IST)	Arm II (Continued IST)	Total
Hispanic or Latino	0	0	0
Not Hispanic or Latino	9	8	17
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Arm I (Discontinued IST)	Arm II (Continued IST)	Total
American Indian or Alaska Native	0	0	0
Asian	1	1	2
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	1	1
White	8	5	13
More than one race	0	1	1
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Arm I (Discontinued IST)	Arm II (Continued IST)	Total
United States	9	8	17

Study locations

1 site

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington 98109, United States

References and documents

Study documents

Protocol and statistical analysis plan · Oct 8, 2020
Informed consent form · Oct 8, 2020

Documents are hosted by the registry — open the source record to download them.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2018 to primary completion in May 2020, 23 months.

Results were first posted in Jun 2021, 1 year 1 month after primary completion.

Of 35 non-industry phase 2 interventional studies under Bronchiolitis Obliterans Syndrome, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 59. This study's 23 months is below that.

Counting every sponsor, half of 51 studies reached it within 43 months; a quarter within 27 and three quarters within 59.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 13, 2018
First posted: Mar 30, 2018
StartActual: Jun 6, 2018
Primary completionActual: May 14, 2020
CompletionActual: Mar 3, 2021
Results first posted: Jun 23, 2021
Last update: Jun 23, 2021

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03483675
Lead sponsor: Fred Hutchinson Cancer Center
Collaborators: National Cancer Institute (NCI)
Responsible party: Stephanie Lee (Professor and Associate Director, Fred Hutchinson Cancer Center) — Principal investigator
First posted: Mar 30, 2018
Start date: Jun 6, 2018
Primary completion: May 14, 2020
Completion: Mar 3, 2021
Results posted: Jun 23, 2021
Last update: Jun 23, 2021

Study contacts

Stephanie Lee

principal investigator · Fred Hutch/University of Washington Cancer Consortium

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Bronchiolitis Obliterans Syndrome →

Other studies from this sponsor

Fred Hutchinson Cancer Center →

Start the discussion