Treatment for patients with steroid-refractory acute graft-versus-host disease

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 study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, dosing, and efficacy of RLS-0071 in hospitalized patients suffering from steroid-refractory acute graft-versus-host disease (aGvHD). It is an open-label, prospective, dose-ranging escalation and expansion trial designed to assess the drug's effectiveness in patients who have not responded to standard steroid treatments. Participants must be hospitalized and meet specific criteria regarding their condition and treatment history. The trial aims to provide insights into the optimal dosing and potential benefits of RLS-0071 for this challenging condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female adults or adolescents (\>12 years old).
* Hospitalized with steroid-refractory aGvHD (grade II-IV) after allo-HSCT
* Anticipated hospital length-of-stay of at least 1 week from the time of RLS-0071 initiation.
* No plans to add additional GvHD treatment medications or to add, dose-adjust, or discontinue GvHD prophylactic medications during the 7-days of RLS-0071 treatment.
* Neutrophil recovery following the stem-cell transplantation, defined as blood neutrophil count \>500/mL for at least 3 consecutive measurements and not supported by growth factor supplementation
* Weight ≥40 kg and ≤ 140 kg at screening.

Exclusion Criteria:

* Has received more than 1 allo-HSCT
* Current, previous, or planned use of any systemic treatment in addition to or other than corticosteroids or ruxolitinib for aGvHD
* Previous failure of ruxolitinib treatment
* Uncontrolled GI infection
* Endoscopic and biopsy testing (if performed) that definitively rules out lower GI aGvHD
* Chronic GvHD
* Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed.
* Unresolved toxicity or complications (other than aGvHD) due to the allo-HSCT
* Any corticosteroid therapy for indications other than aGvHD at doses of methylprednisolone or equivalent \>1 mg/kg per day within 7 days of enrollment.
* Severe organ dysfunction unrelated to underlying aGvHD
* Known hypersensitivity, allergy, or anaphylactic reaction to polyethylene glycol (PEG)
* Significant liver disease that is unrelated to GvHD
* Severe kidney disease
* Currently breast feeding.
* Known pregnancy, a positive pregnancy test at screening, or lactation for WOCBP.
* Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or human immunodeficiency virus (HIV)-1 or HIV-2.
* Active sepsis

Where it's running

• Site 3242
  Freiburg im Breisgau, Germany Recruiting
• Site 3101
  Seville, Se, Spain Recruiting
• Site 3360
  Madrid, Spain Recruiting
• Site 3227
  Salamanca, Spain Recruiting
• Site 3101
  Seville, Spain Recruiting
• Site 1091
  Duarte, California, United States Active not recruiting

Study contacts

• Study coordinator: Linda Dell, MBA
• Email: ldell@realtals.com
• Phone: 201-675-4044

Similar studies

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

• Moxibustion with second-line treatment for steroid-refractory acute graft-versus-host disease after transplant

  This study will test whether adding moxibustion to standard second-line drug therapy helps people aged 14–65 with steroid-refractory gastrointestinal acute GVHD after an allogeneic stem cell transplant.

  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07572669

• Treatment for steroid-refractory acute graft-versus-host disease using mesenchymal stromal cells

  This study is testing a new type of cell therapy to see if it can help adults and teens with a tough form of graft-versus-host disease that hasn't improved with standard treatments.

  Recruiting at 35 sites Phase 3 medac GmbH · Amiens and 41 other locations · NCT04629833

• Using cord blood cells with ruxolitinib to treat steroid-refractory acute graft versus host disease

  This study is testing whether adding special cells from cord blood to the medication ruxolitinib can help people with acute graft versus host disease who haven't responded to steroids.

  Recruiting Early Phase 1 M.D. Anderson Cancer Center · Houston, Texas · NCT04744116

• Evaluating iMesenchymal Stromal Cells for Steroid-Refractory Acute Graft-versus-Host Disease

  This study is testing if a new type of stem cell treatment can help people with acute graft-versus-host disease who haven't responded to steroids.

  Recruiting Anhui Provincial Hospital · Hefei, Anhui · NCT06321198

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.