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Compares treatment options for Steroid-Refractory Acute Graft-Versus-Host Disease
Official title Moxibustion for Steroid-Refractory Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT07572669
What this study is testing
What is Best Available Treatment (BAT)?
Best Available Treatment (BAT) is an investigational medicine, given as an once-daily, being studied as a potential treatment for steroid-refractory acute graft-versus-host disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a prospective, multicenter, open-label, phase II clinical trial designed to evaluate the safety and efficacy of moxibustion in patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT). A total of 42 patients with SR-aGVHD, primarily involving the gastrointestinal tract and presenting with abdominal pain and diarrhea, will be enrolled.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 65
You may be able to join if
- Participants must meet all of the following criteria:
- Age 14 to 65 years, male or female. Underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT). Diagnosis of acute graft-versus-host...
- Steroid-refractory or steroid-dependent aGVHD, defined as:
- Disease progression within 3 days of systemic corticosteroid treatment, or No response within 7 days, or Failure to achieve complete response after...
- Female participants of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during the...
You likely can't join if
- Participants meeting any of the following criteria will be excluded:
- Prior treatment with ≥1 systemic therapy for aGVHD other than corticosteroids. Diagnosis of GVHD overlap syndrome according to NIH criteria. History...
- Unresolved toxicities or complications from prior transplantation (excluding GVHD).
- Prior moxibustion therapy after transplantation. Uncontrolled active infection. Known human immunodeficiency virus (HIV) infection. Active hepatitis...
- Receipt of other investigational therapy within 21 days prior to enrollment (or within 5 half-lives, whichever is longer).
- Renal dysfunction: serum creatinine ≥ 2.0 mg/dL or creatinine clearance \< 40 mL/min.
See the full eligibility criteria
- Participants must meet all of the following criteria:
- Age 14 to 65 years, male or female. Underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT). Diagnosis of acute graft-versus-host disease (aGVHD) according to standard criteria, with gastrointestinal...
- Steroid-refractory or steroid-dependent aGVHD, defined as:
- Disease progression within 3 days of systemic corticosteroid treatment, or No response within 7 days, or Failure to achieve complete response after 28 days of immunosuppressive therapy, or Recurrence or worsening during...
- Female participants of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during the study.
- Male participants must agree to use effective contraception during the study. Ability to understand and willingness to sign a written informed consent form. Willingness and ability to comply with study procedures and...
- Participants meeting any of the following criteria will be excluded:
- Prior treatment with ≥1 systemic therapy for aGVHD other than corticosteroids. Diagnosis of GVHD overlap syndrome according to NIH criteria. History of splenectomy after transplantation. Evidence of relapse of the...
- Unresolved toxicities or complications from prior transplantation (excluding GVHD).
- Prior moxibustion therapy after transplantation. Uncontrolled active infection. Known human immunodeficiency virus (HIV) infection. Active hepatitis B or C infection requiring treatment, or risk of HBV reactivation.
- Receipt of other investigational therapy within 21 days prior to enrollment (or within 5 half-lives, whichever is longer).
- Renal dysfunction: serum creatinine ≥ 2.0 mg/dL or creatinine clearance \< 40 mL/min.
- Hepatic dysfunction unrelated to GVHD, including cholestatic disease or unresolved hepatic veno-occlusive disease.
- Severe cardiovascular disease, including unstable angina, myocardial infarction within 6 months, NYHA class III-IV heart failure, or circulatory failure requiring vasoactive support.
- Severe respiratory disease requiring mechanical ventilation or ≥50% oxygen support.
- Use of high-dose corticosteroids (≥1 mg/kg/day methylprednisolone or equivalent) for non-GVHD indications within 7 days prior to enrollment.
- Pregnant or breastfeeding women. Severe skin damage or known allergy/intolerance to study-related procedures. Any other condition that, in the investigator's judgment, would interfere with study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.