Acute Graft Versus Host Disease

23

Review clinical trials related to Acute Graft Versus Host Disease. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Dental Cleaning to Prevent Chronic Graft-Versus-Host Disease

This clinical trial evaluates the feasibility and effectiveness of a post-transplant dental cleaning for the prevention of chronic graft versus host disease (GVHD) in patients undergoing an allogeneic hematopoietic cell transplant (HCT). HCT is the only curative treatment for some types of blood cancer. Unfortunately, this approach can lead to the development of GVHD, which is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Some research has shown that the bacteria that is present in the dental plaque soon after transplant may affect the development of chronic GVHD. Dental cleanings prior to transplant are part of the normal standard of care for patients undergoing HCT. Adding an additional cleaning shortly after HCT may be effective for preventing the development of chronic GVHD.

Participants needed: 45
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Fred Hutchinson Cancer CenterUpdated: Jun 22, 2026Locations: 1
Eligibility criteria

Age ≥ 18 years old [+5]

Edentulous state [+3]

Status: Recruiting

FMT in Gut aGVHD Treated

With the stem cell transplanting increasing, patients which effected with gut GVHD were also increased. To evaluation the safety and efficacy of FMT for gut GVHD,patients with gut GVHD were recruited.

Participants needed: 50
Trial details
Age: 10-60Biological sex: AllType: ObservationalSponsor: The First Affiliated Hospital of Soochow UniversityUpdated: Jun 1, 2026Locations: 1
Eligibility criteria

gut GVHD

Age>60; or Age<10

Status: Recruiting

Moxibustion for Steroid-Refractory Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

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. All participants will receive standard second-line therapy based on best available treatment (BAT), including ruxolitinib, basiliximab, or methotrexate, according to clinical judgment. In addition, patients will receive moxibustion at specific acupoints (Tianshu \[ST25\], Shenque \[CV8\], and Qihai \[CV6\]) for 30 minutes once or twice daily for 28 days. The primary endpoint is the overall response rate (ORR) at Day 28. Secondary endpoints include durable ORR at Day 56, incidence and severity of chronic GVHD (cGVHD), non-relapse mortality (NRM), overall survival (OS), and changes in traditional Chinese medicine (TCM) syndrome scores. Safety will be assessed by monitoring adverse events throughout the study period. This study aims to explore whether moxibustion, as an adjunctive therapy, can improve clinical outcomes and provide a safe and effective treatment strategy for patients with SR-aGVHD after allo-HSCT.

Participants needed: 42
Trial details
Phase: Phase 2Age: 14-65Biological sex: AllType: InterventionalSponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUpdated: May 7, 2026Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

MAGIC Ruxolitinib for aGVHD

This clinical trial will study ruxolitinib-based treatment of acute graft-versus-host-disease (GVHD) that developed following allogeneic hematopoietic cell transplant. Acute GVHD occurs when donor cells attack the healthy tissue of the body. The most common symptoms are skin rash, jaundice, nausea, vomiting, and/or diarrhea. The standard treatment for GVHD is high dose steroids such as prednisone or methylprednisolone, which suppresses the donor cells, but sometimes there can be either no response or the response does not last. In these cases, the GVHD can become dangerous or even life threatening. High dose steroid treatment can also cause serious complications. Researchers have developed a system, called the Minnesota risk system, to help predict how well the GVHD will respond to steroids based on the symptoms present at the time of diagnosis. The Minnesota risk system classifies patients with newly diagnosed acute GVHD into two groups with highly different responses to standard steroid treatment and long-term outcomes. This protocol maximizes efficiency because all patients with grade II-IV GVHD are eligible for screening and treatment is assigned according to patient risk. Patients with lower risk GVHD, Minnesota standard risk, have high response rates to steroid treatment. In this trial the researchers will test whether ruxolitinib alone is as effective (non-inferior) as steroid-free therapy and safe. Patients will be randomized to two different doses of ruxolitinib to identify the dose which maximizes efficacy while minimizing toxicities such as hematologic and infectious toxicities. Patients with higher risk GVHD, Minnesota high risk, have unacceptable outcomes with systemic corticosteroid treatment alone and the researchers will test whether adding ruxolitinib, a proven effective second line GVHD treatment, can improve outcomes when added to systemic corticosteroids as first line treatment.

Participants needed: 98
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: John LevineUpdated: Mar 23, 2026Locations: 14
Eligibility criteria

Standard risk cohort: Minnesota standard risk GVHD (except patients with grade I... [+6]

Systemic treatment with ruxolitinib or any other JAK inhibitor within 7 days of... [+11]

Status: Recruiting

A Phase Ib Clinical Study of AC-003 Capsules in Subjects With aGVHD.

The study was an open-label, single-arm, dose-escalation, Phase Ib, multi-center study to investigate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of AC-003 in patients with grade II-IV SR-aGVHD.

Participants needed: 24
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Accro Bioscience (Suzhou) LimitedUpdated: Mar 16, 2026Locations: 1
Eligibility criteria

Male or female patients age ≥ 18 years. [+6]

Evidence of aGVHD relapsed. [+6]

Status: Recruiting

Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial

This study is about determining if an aerobic and resistance exercise intervention is feasible in patients diagnosed with acute or chronic GVHD (Graft-Versus-Host Disease) after having an allogeneic stem cell transplant. The names of the study interventions involved in this study are: * Aerobic and resistance exercise (A+R) - Home-based aerobic and resistance exercise program * Attention control (AC) - Home-based stretching program

Participants needed: 36
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Dana-Farber Cancer InstituteUpdated: Mar 11, 2026Locations: 2
Eligibility criteria

Over 18 years old; children under the age of 18 will be excluded due to rarity o... [+7]

Have a plan for hospital admission within the next 13 weeks at the time of recru... [+8]

Status: Recruiting

Effect of Stem Cell Infusion Time on aGVHD in Patients With Hematological Malignancies Post UCBT

To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with malignant hematologic diseases after single-unit unrelated cord blood transplantation (sUCBT).

Participants needed: 134
Trial details
Phase: Phase 3Biological sex: AllType: InterventionalSponsor: Anhui Provincial HospitalUpdated: Dec 23, 2025Locations: 1
Eligibility criteria

Definite diagnosis of malignant hematologic disease before transplantation, age,... [+6]

Those with severe organ dysfunction or disease, such as severe disease and dysfu... [+3]

Status: Recruiting

First-Line Jaktinib for Acute Graft-Versus-Host Disease (aGVHD)

This study aims to evaluate the optimal dose (Recommended Phase 2 Dose, RP2D), preliminary safety, and efficacy of gecacitinib (also known as jaktinib) in combination with glucocorticoids as first-line therapy for patients with grade II-IV acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Participants needed: 35
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Zhejiang UniversityUpdated: Dec 16, 2025Locations: 1
Eligibility criteria

Voluntarily provide signed informed consent and be ≥18 years of age at the time... [+8]

History of ≥2 allo-HSCT procedures. [+23]

Status: Not yet recruiting

Clinical Observation on the Efficacy of Patient-Donor Derived Probiotics in Improving Intestinal Flora Disorder in Patients With Intestinal Acute Graft-Versus-Host Disease (aGVHD)

To clinically evaluate the efficacy of patient- and/or donor-derived probiotics in ameliorating intestinal flora dysbiosis in patients with acute intestinal graft-versus-host disease (aGVHD), thereby mechanistically enhancing clinical outcomes and quality of life through intestinal microbiome modulation.

Participants needed: 10
Trial details
Age: 50+Biological sex: AllType: InterventionalSponsor: Institute of Hematology & Blood Diseases Hospital, ChinaUpdated: Sep 23, 2025Locations: 1
Eligibility criteria

Age >50 years, regardless of gender; [+3]

Active or chronic infectious diseases, including recent febrile symptoms (axilla... [+3]

Status: Recruiting

Anti-CD25 rhMAb for aGVHD Prevention in High-Risk Adults Using the daGOAT Model

To assess the efficacy and safety of using recombinant humanized anti-CD25 monoclonal antibody injection as a prophylactic strategy for reducing the incidence of severe acute graft-versus-host disease (aGVHD) in adult patients at intermediate to high risk, as predicted by the dynamic aGVHD Onset Anticipation Tianjin (daGOAT) model, following allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Participants needed: 174
Trial details
Phase: Phase 2Age: 16+Biological sex: AllType: InterventionalSponsor: Institute of Hematology & Blood Diseases Hospital, ChinaUpdated: Aug 8, 2025Locations: 1
Eligibility criteria

Age ≥ 16 years, regardless of gender. [+2]

Patients who have received a second or multiple transplants. [+2]

Status: Recruiting

Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies

This phase I trial tests the safety and side effects of leflunomide in combination with steroids in treating patients with acute graft versus host disease who have undergone done stem cell transplant for blood cancers (hematologic malignancies). Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Leflunomide and steroids are immunosuppressive drugs that work in different ways to lower the body's immune response so that the new donor immune cells do not attack the body's normal cells. Giving leflunomide in combination with steroids may help treat acute graft versus host disease in patients after stem cell transplant for hematologic malignancies.

Participants needed: 18
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: City of Hope Medical CenterUpdated: Jul 4, 2025Locations: 1
Eligibility criteria

Documented informed consent of the participant and/or legally authorized represe... [+19]

Recipient of more than one allogeneic HCT [+23]

Status: Recruiting

Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases

To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with nonmalignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT)

Participants needed: 198
Trial details
Phase: Phase 3Age: 12-60Biological sex: AllType: InterventionalSponsor: Anhui Provincial HospitalUpdated: Jun 26, 2025Locations: 6
Eligibility criteria

Definite diagnosis of malignant hematologic disease before transplantation, age... [+5]

Those with severe organ dysfunction or disease, such as severe disease and dysfu... [+5]

Status: Recruiting

Mini-dose MTX Plus Standard-dose Steroid for the Initial Treatment of Acute GVHD

This trial is a randomized (1:1) phase III open label study of frontline mini-MTX plus methylprednisolone 2mg/kg/day compared to methylprednisolone 2mg/kg in allogeneic stem cell transplant recipients with grade 2-4 aGVHD.

Participants needed: 218
Trial details
Phase: Phase 3Age: 15-65Biological sex: AllType: InterventionalSponsor: Peking University People's HospitalUpdated: Jun 3, 2025Locations: 2
Eligibility criteria

Patients who are fully informed and sign informed consent by themselves or their... [+6]

Patients with severe brain, heart, kidney or liver dysfunction unrelated to graf... [+7]

Status: Not yet recruiting

A Study of iMSC for the Prevention of Acute Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

An open-label, randomized, controlled clinical trial to explore the efficacy and safety of iMSC in preventing the development of acute graft-versus-host disease of degree III-IV in patients after allogeneic hematopoietic stem cell transplantation.

Participants needed: 56
Trial details
Phase: Early Phase 1Age: 14-70Biological sex: AllType: InterventionalSponsor: Ruijin HospitalUpdated: Apr 29, 2025
Eligibility criteria

Subjects with malignant or nonmalignant hematologic diseases 7-21 days after all... [+7]

Serious organ dysfunction such as organ failure after allogeneic HSCT; [+10]

Status: Not yet recruiting

A Trial to Evaluate the Safety and Efficacy of NCR102 in Subjects With aGVHD

Evaluate the safety and efficacy of NCR102 injection in the treatment of SR-aGVHD patients who have failed second-line therapy.

Participants needed: 24
Trial details
Phase: Phase 1, Phase 2Age: 18-70Biological sex: AllType: InterventionalSponsor: Nuwacell Biotechnologies Co., Ltd.Updated: Apr 23, 2025
Eligibility criteria

Age>18 years and <70 years old (including threshold), gender not limited; [+5]

Subjects have lung disease, and investigators have determined that they are not... [+7]

Status: Recruiting

Efficacy of Human Chorionic Gonadotropin in Acute GVHD Treatment

Graft-versus-host disease is a complication of allogeneic hematopoietic cell transplantation with high morbidity and mortality. The standard treatment is corticosteroids, and based on the response within 3 to 7 days, a second-line therapy is added, which is expensive and not easily accessible. The administration of human chorionic gonadotropin has shown therapeutic effectiveness in 50% of patients in reported clinical cases.

Participants needed: 20
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Hospital Universitario Dr. Jose E. GonzalezUpdated: Apr 3, 2025Locations: 1
Eligibility criteria

Aged 18 years or older. [+7]

Arterial or venous thrombosis in the past 3 months. [+6]

Status: Recruiting

Universal CNK-UT Therapy for Refractory aGVHD

This is a single arm, open-label, multi-center, pilot studies (Investigator Initiated Trial, IIT) to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of universal T-cells engineered with chimeric natural killer receptor (CNK-UT) to treat the patients with steroid-refractory/resistant or steroid-dependent aGVHD.

Participants needed: 23
Trial details
Phase: Phase 1Age: 14-70Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Zhejiang UniversityUpdated: Dec 27, 2024Locations: 2
Eligibility criteria

Aged 14-70 years, male or female; [+5]

Suffering from malignant tumors or diagnosed within 5 years before enrollment, e... [+13]

Status: Recruiting

Tissue-resident Immune Cell Subsets in aGVHD

This is a prospective study investigating the role of tissue-resident immune cell subsets in the occurrence and progression of graft-versus-host disease following hematopoietic stem cell transplantation. Approximately 40 subjects(including 20 grade 3-4 aGVHD patients and 20 grade 1-2 aGVHD patients ).

Participants needed: 40
Trial details
Age: 18-65Biological sex: AllType: ObservationalSponsor: Nanfang Hospital, Southern Medical UniversityUpdated: Nov 27, 2024Locations: 1Duration: 100 Days
Eligibility criteria

Voluntarily sign the informed consent form; [+2]

Have a history of other tumors [+5]

Status: Not yet recruiting

A Clinical Study of Bacillus Coagulans in Acute Graft-Versus-Host Disease After Hematopoietic Stem Cell Transplantation

To evaluate the preventive effect of Bacillus coagulans on acute graft-versus-host disease (aGVHD) after hematopoietic stem cell transplantation

Participants needed: 286
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Yamin FanUpdated: Sep 25, 2024
Eligibility criteria

Patients are fully aware of the study, voluntarily participate and sign informed... [+2]

Refused to participate in this clinical study; [+3]

Status: Not yet recruiting

Low-dose Cyclophosphamide or CNI in the Prevention of Acute Graft-versus-host Disease After gDLI

Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used to after gDLI. Evaluate the overall survival rate (OS), non recurrent mortality rate (NRM), and recurrence rate (CIR) of two groups of patients; The complete response rate (CR) and partial response rate (PR) of patients with morphological/extramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrence. The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups.

Participants needed: 66
Trial details
Biological sex: AllType: InterventionalSponsor: Institute of Hematology & Blood Diseases Hospital, ChinaUpdated: Jul 8, 2024
Eligibility criteria

Patients with malignant hematological diseases undergo haploid/sibling incomplet... [+5]

Siblings of matched donor transplant; [+12]

Status: Not yet recruiting

Effectiveness and Safety of a Single-Center Clinical Study on a CD25 Monoclonal Antibody-Containing GVHD Prophylaxis Scheme to Reduce the Incidence of Severe Acute GVHD After Umbilical Cord Blood Transplantation for Malignant Hematologic Diseases

Evaluating the safety and effectiveness of a CD25 monoclonal antibody-based prophylactic acute graft-versus-host-disease (aGVHD) regimen following unrelated umbilical cord blood transplantation (UCBT) for malignant hematologic disorders in reducing severe aGVHD.

Participants needed: 39
Trial details
Phase: Phase 2Biological sex: AllType: InterventionalSponsor: Anhui Provincial HospitalUpdated: Jun 28, 2024Locations: 1
Eligibility criteria

Malignant hematologic disorders; [+2]

Non-malignant hematologic disorders; [+7]

Status: Not yet recruiting

Combination of Steroid and Humanized CD25 Monoclonal Antibody as First-line Therapy for aGVHD

The first-line treatment of acute graft-versus-host disease with humanized CD25 monoclonal antibody combined with glucocorticoid was used to study the remission rate of acute graft-versus-host disease, the cumulative incidence and remission rate of severe acute graft-versus-host disease, GVHD-free survival rate, all-cause mortality and quality of life evaluation, and safety evaluation for prevention programs.

Participants needed: 20
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Institute of Hematology & Blood Diseases Hospital, ChinaUpdated: Jun 25, 2024
Eligibility criteria

( 1 ) Diagnosis of grade II to IV acute graft-versus-host disease after hematopo...

• (1) diagnosed as VOD/SOS. [+9]

Status: Not yet recruiting

Study on the Serum Metabolic Markers and Early Complications After Allo-HSCT: Cohort Study

This study aims to establish a cohort of 500 patients with hematological disease who undergoing allogeneic hematopoietic stem cell transplantation in the northwest region. All patients will be followed up at the outpatient clinic once a week after transplantation until 100 days after transplantation to observe the presence of acute graft versus host disease, acute kidney damage, and major cardiovascular adverse events. Serum samples from the day before pre-treatment, day after pre-treatment, 2 weeks,4 weeks,8 weeks and 12 weeks after transplantation will be detected by metabolomics sequencing.The primary objective is to explore the serum metabolic markers of acute graft versus host disease,acute kidney injury, and major adverse cardiac events within 100 days after transplantation,the secondary objective is to observe the high-risk factors for early complications.

Participants needed: 500
Trial details
Age: 0-65Biological sex: AllType: ObservationalSponsor: First Affiliated Hospital Xi'an Jiaotong UniversityUpdated: Apr 26, 2024
Eligibility criteria

Age ≤ 65 years old;

CREA or BUN higher than the normal upper limit value before transplantation;