Chronic Graft Versus Host DiseasePhase 2NCT03483675
Discontinuation or Continuation of Immunosuppressive Therapy in Participants With Chronic Graft Versus Host Disease
A Phase 2 study testing Immunosuppressive Therapy and Survey Administration in people with Chronic Graft Versus Host Disease, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Graft Versus Host Disease
- What is being tested?
- Immunosuppressive Therapy and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2018to 3 Mar 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to comply with study procedures
- Pregancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Randomized Feasibility Study of Discontinuation Versus Continuation of Immunosuppressive Therapy (IST) in Patients With Chronic Graft Versus Host Disease (GVHD)
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:
- 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:
- 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
- Chronic Graft Versus Host Disease
- Being tested
- Immunosuppressive Therapy, Survey Administration
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunosuppressive TherapyBiological
Also called Anti-Rejection Therapy, immunosuppression
Discontinued IST
Immunosuppressive TherapyBiological
Also called Anti-Rejection Therapy, immunosuppression
Continued IST
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (discontinued IST) | Active comparator | Participants have their IST tapered and discontinued per the plan. Receives: Biological: Immunosuppressive Therapy; Other: Survey Administration |
| Arm II (continued IST) | Experimental | Participants continue to receive a fixed dose IST for an additional 9 months with no taper. Receives: Biological: Immunosuppressive Therapy; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Enrolling Patients
Descriptive summary of number of patients enrolled on the study (signed consent)
Measured: 22.9 months
Secondary outcomes (9)
Feasibility of Randomizing Patients
Descriptive summary of percentage of patients randomized.
Measured: 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).
Measured: Up to 12 months after randomization
Compliance With Data Collection
Count of surveys completed by physicians and patients
Measured: 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
Measured: Up to 12 months after randomization
Recurrent Malignancy
Incidence of relapse of primary disease
Measured: Up to 12 months after randomization
Incidence of Grade >= 3 Infections
Incidence of grade >= 3 infections
Measured: Up to 12 months after randomization
Incidence of Grade >= 3 Organ Toxicity
Incidence of grade >= 3 organ toxicity
Measured: 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.
Measured: 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.
Measured: Up to 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start6 Jun 2018
- Primary completion14 May 2020
- Study completion3 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Stephanie Lee, Fred Hutchinson Cancer Center
- Investigators
- Stephanie Lee, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483675
- Sponsor's protocol ID
- 9962
- Other IDs
- NCI-2018-00323, 9962, P30CA015704, RG1001667
- Status last verified
- Jun 2021
- First submitted
- 13 Mar 2018
- Last updated
- 23 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Feasibility Study of Discontinuation Versus Continuation of Immunosuppressive Therapy (IST) in Patients With Chronic Graft Versus Host Disease (GVHD)
- ClinicalTrials.gov ID
- NCT03483675
- Acronym / sponsor ID
- 9962
- Conditions
- Chronic Graft Versus Host Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Posted 23 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (discontinued IST) | Active comparator | Biological: Immunosuppressive Therapy, Other: Survey AdministrationParticipants have their IST tapered and discontinued per the plan. |
| Arm II (continued IST) | Experimental | Biological: Immunosuppressive Therapy, Other: Survey AdministrationParticipants continue to receive a fixed dose IST for an additional 9 months with no taper. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to comply with study procedures
- Pregancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunosuppressive TherapyAlso: Anti-Rejection Therapy, immunosuppressionDiscontinued IST | Biological | Arm I (discontinued IST) |
| Immunosuppressive TherapyAlso: Anti-Rejection Therapy, immunosuppressionContinued IST | Biological | Arm II (continued IST) |
| Survey AdministrationAncillary studies | Other | Arm I (discontinued IST), Arm II (continued IST) |
Primary outcome
Feasibility of Enrolling Patients
Time frame: 22.9 months
Descriptive summary of number of patients enrolled on the study (signed consent)
9 secondary outcomes
Feasibility of Randomizing Patients
Time frame: 22.9 months
Compliance With Treatment
Time frame: Up to 12 months after randomization
Compliance With Data Collection
Time frame: Up to 12 months after randomization
Graft Versus Host Disease Manifestations
Time frame: Up to 12 months after randomization
Recurrent Malignancy
Time frame: Up to 12 months after randomization
Incidence of Grade >= 3 Infections
Time frame: Up to 12 months after randomization
Incidence of Grade >= 3 Organ Toxicity
Time frame: Up to 12 months after randomization
Enrollment Rate of Participants Who Are Not Local
Time frame: Up to 12 months after randomization
Quality of Data of Participants Who Are Not Local
Time frame: Up to 12 months after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Lee principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immunosuppressive Therapy and Survey Administration in people with Chronic Graft Versus Host Disease, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Enrolling Patients (time frame: 22.9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.