Understanding chronic graft-versus-host disease outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the clinical and biological factors that influence outcomes in patients with chronic graft-versus-host disease (cGVHD) following allogeneic hematopoietic stem cell transplantation. It will establish a multidisciplinary clinic to study the pathogenesis and natural history of cGVHD, identify prognostic markers, and develop grading scales for clinical relevance. The study will also explore the biological characteristics of cGVHD and their relationship with clinical presentations, ultimately aiming to improve treatment strategies for affected patients.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA:

  1. Any patient age 1 and older referred by the primary transplant physician for the evaluation of chronic graft-versus-host disease independently of age or underlying diagnosis
  2. Patient or the patient's legal representative is able and willing to provide consent.

EXCLUSION CRITERIA:

1. Significant medical condition or any other significant circumstance that could in the PIs assessment affect the patient's ability to tolerate, comply, or complete the study
2. Patients who in the PIs assessment have a life expectancy \<3 months.

   Note: Because it is not always possible to make a clear clinical distinction between acute and chronic GVHD, patients with acute GVHD are not a-priori excluded until the possibility of chronic GVHD is reliably excluded on the basis of the clinical assessments in the cGVHD clinic.
3. Pregnant women are excluded from this study because multiple tests would need to be excluded for safety of the patient and the fetus.

Inclusion Criteria for control subjects without cGVHD:

* Age 1 and older
* Patient has undergone Allo-HSCT
* Patient or the patient's parent/guardian is able and willing to provide consent

Exclusion Criteria for control subjects without cGVHD:

* Active GVHD
* In the previous three months have received systemic immunosuppressant therapy for the treatment of GVHD
* In the previous three months have received therapy for malignancy

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Najla El Jurdi, M.D. — National Cancer Institute (NCI)
• Study coordinator: Najla El Jurdi, M.D.
• Email: najla.eljurdi@nih.gov
• Phone: (240) 992-4033

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ruxolitinib for corticosteroid-refractory chronic graft-versus-host disease in Chinese patients

  This trial will try ruxolitinib in Chinese adolescents (12+) and adults whose chronic graft-versus-host disease has not improved with corticosteroids.

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• Low-dose liposomal amphotericin B to prevent invasive fungal infections in neutropenic children

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  Recruiting Haikou Affiliated Hospital of Central South University Xiangya School of Medicine · Haikou, Hainan · NCT07725263

• Madecassoside tablets plus standard therapy for sclered scl-cGVHD after allo-HSCT

  This study tests whether adding madecassoside tablets to standard therapy can help people with scleral chronic graft-versus-host disease after stem cell transplant.

  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07606703

• T-cell–guided letermovir stopping after allogeneic stem cell transplant

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• Fatigue and thinking problems after allogeneic stem cell transplant (synapse damage or brain GVHD)

  This project uses PET scans and spinal fluid samples to try to find why people who had an allogeneic stem cell transplant have persistent fatigue and thinking problems.

  Recruiting Karolinska University Hospital · Stockholm · NCT07365696

• Fecal microbiota transplantation for steroid-refractory acute GI-GvHD

  This trial tests whether fecal microbiota transplantation can help adults with steroid-refractory acute gastrointestinal graft-versus-host disease after stem cell transplant.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.