New tools could help doctors predict who will respond to chronic GVHD therapies
NCT ID NCT01902576
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times
Summary
This study involves 383 people who have chronic graft-versus-host disease (GVHD) after a stem cell transplant. Researchers are developing and testing new ways to measure whether a treatment is working, including a symptom-based activity index and a score that predicts long-term success without treatment failure. The goal is to create better tools for future clinical trials and patient care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could provide doctors with better ways to measure if a chronic GVHD treatment is working, and help predict which patients will respond to which therapies.
- What could go wrong
- This is an observational study focused on developing measurement tools, not testing a new treatment. The tools may not prove accurate enough for widespread use, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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383 people
The number who actually took part.
- Started
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Jun 2013
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients starting initial or subsequent therapy for chronic Graft vs Host Disease.
- Ages
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7 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 7 years or older * Prior first allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis. * Diagnosis of chronic GVHD according to the criteria of the diagnosis and scoring group of the NIH consensus conference (Patient must have at least one diagnostic manifestation of chronic GVHD or one distinctive manifestation with pathological confirmation of the diagnosis. Concurrent acute GVHD manifestations will be allowed as long as at least one classic chronic manifestation is present.) * Initiation of a new systemic treatment for chronic GVHD in the past 4 weeks or anticipated within the next 4 weeks. Systemic treatment is defined as any medication or intervention that has intended systemic effects, including extracorporeal photopheresis, regardless of prior lines of therapy or prior treatment with the agent(s). If a patient is restarting a treatment to which they were previously exposed, they must have been off of it for at least 4 weeks before restarting. * No evidence of persistent or progressive malignancy at the time of enrollment * Evaluation at the transplant center at the time of study enrollment, and agreement to be re-evaluated at the transplant center up to four subsequent times: at 3 months, 6 months, and 18 months after enrollment and once if another treatment is added for chronic GVHD. * Signed, informed consent Exclusion Criteria: * Inability to comply with study procedures * Complete resolution of chronic GVHD at the time of enrollment (patient must have some measurable chronic GVHD activity)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stem cell infusions put to the test against a tough transplant complication
- Can adding rituximab improve remission in chronic GVHD?
- Can a new drug regimen beat the standard for stem cell transplant complications?
- Can a new pill tame the immune System's attack after stem cell transplants?
- One vitamin a pill before transplant: a new shield against a deadly complication?
- Can a new pill outperform standard care for a tough transplant complication?