Predicting Treatment Response for GVHD

Recruiting at 3 trial locations

Overseen By Gaby Desatnik

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Research Center

Disqualifiers: Uncontrolled psychiatric disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help doctors predict how well patients with chronic graft-versus-host disease (cGVHD) will respond to new treatments. Researchers will collect clinical data and blood samples from patients before and after they start a new therapy. By analyzing these samples and information, they aim to identify changes that may indicate whether the treatment is effective. This trial might suit those who have had an allogeneic stem cell transplant and are about to begin a new treatment plan for cGVHD. Participants will complete short questionnaires and have their medical records and blood samples reviewed over several months. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Why are researchers excited about this trial?

Researchers are excited about this trial because it seeks to uncover personalized insights into treating chronic graft-versus-host disease (cGVHD) by predicting how patients respond to specific therapies. Unlike standard treatments that may not consider individual variability, this approach involves analyzing patients' blood samples and medical records alongside their quality-of-life assessments. By focusing on these personalized factors, this trial aims to tailor treatments more effectively, potentially leading to better outcomes and improved patient well-being.

Who Is on the Research Team?

Stephanie J. Lee

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

Inclusion Criteria

Prior allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis

No evidence of persistent or progressive malignancy at the time of enrollment

Agrees to be evaluated at the transplant center before initial or second-line treatment is started (may be concurrent with the enrollment visit), and later between 2-6 weeks, 3 months and 6 months after treatment is started or if a new therapy is started before 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete questionnaires and have their medical records reviewed. Blood samples are collected.

1 day

1 visit (in-person)

Observational Follow-up

Participants complete questionnaires and have their medical records reviewed at 1, 3, and 6 months after starting index treatment. Blood samples are collected at 1 month.

6 months

4 visits (in-person)

Long-term Follow-up

Participants are monitored for time to next systemic treatment and patient-reported outcomes up to 3 years.

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Biospecimen Collection
• Medical Chart Review
• Quality-of-Life Assessment
• Questionnaire Administration

How Is the Trial Designed?

Group I: Observational (questionnaire, biospecimen, chart review) Experimental Treatment 4 Interventions

Patients complete questionnaires over 10 minutes about physical symptoms, activity level, and emotional well-being and have their medical records reviewed at baseline, 1, 3, and 6 months after starting index treatment, and at start of a new systemic treatment. Patients also undergo collection of blood samples over 1-2 minutes at baseline and at 1 month after starting index treatment, or at a treatment change visit if new therapy has not started.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Research Center

Lead Sponsor

Trials

444

Recruited

148,000+

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+