New drug shows promise in preventing Graft-Versus-Host disease
NCT ID NCT03207958
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tested the drug belimumab (Benlysta) to see if it could prevent chronic graft-versus-host disease (GvHD) in 10 adults who had a stem cell transplant for blood cancer. GvHD is a serious condition where the donor's immune cells attack the patient's body. The main goal was to check if the drug was safe and tolerable. Results help guide future research, but the study was too small to prove effectiveness.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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10 people
The number who actually took part.
- Started
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May 2018
- Finished
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Feb 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * At least 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Diagnosis of hematologic malignancy (i.e. acute myeloid leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia, chronic myelogenous leukemia, Hodgkin's lymphoma, non-Hodgkin's lymphoma, myelodysplastic syndrome, chronic myelomonocytic leukemia) * Use of myeloablative or non-myeloablative conditioning regimen * Use of mobilized peripheral blood stem cells from fully HLA-matched related or unrelated donor as a graft source * Acute GvHD prophylaxis with methotrexate and tacrolimus * Documented complete remission with full donor engraftment (by STR identity testing) on Day +30 bone marrow biopsy * Complete remission: less than 5% blasts in an aspirate bone marrow sample with a count of at least 200 nucleated cells, no blasts with Auer rods or persistence of extramedullary disease PLUS absolute neutrophil count (ANC) \> 1,500/μL, platelet count ≥ 50,000/μL and no leukemic blasts in the peripheral blood. * Negative minimal residual disease * Full donor engraftment by STR testing (either by bone marrow or peripheral blood testing) * Adequate end organ function: * Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN * Creatinine clearance ≥ 40 mL/min/1.73 m\^2 by the Cockcroft-Gault formula * Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for 16 weeks after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent. Exclusion Criteria: * Active grade III-IV classic acute GvHD; subjects with prior resolved acute GvHD on stable doses of immunosuppression at time of enrollment will be permitted * Evidence of classic chronic GvHD or overlap chronic GvHD at time of enrollment * Subjects who participated in a clinical trial of acute GvHD prophylaxis in which chronic GvHD was a secondary end point * Donor lymphocyte infusion administered to treat relapse or loss of donor chimerism * Treatment with rituximab or other anti-B cell specific antibodies within previous 3 months * History of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix * Currently receiving any other investigational agents * Known allergy or intolerance to any component of belimumab, including human or murine proteins or monoclonal antibodies * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations (including current drug or alcohol abuse or dependence, or history of drug or alcohol abuse or dependence within the last year) that would limit compliance with study requirements * Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within 14 days prior to planned start of therapy * Evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months and/or poses a significant suicide risk in the judgment of the investigator * History of pre-existing immunodeficiency disorder, autoimmune condition, or chronic infection * Known HIV positivity * Serologic evidence of current or past hepatitis B infection based on the results of testing for HBsAg and anti-HBc - Patients positive for HBsAg or HBcAb are excluded * Positive test for hepatitis C antibody (patients with documented clearance of hepatitis C by PCR following treatment will be permitted) * Currently on therapy for active chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria). Prophylactic therapy is allowed. * Has any other clinically significant abnormal laboratory value in the opinion of the investigator
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a frailty score predict which older cancer patients survive intensive care?
- Stem cell infusions put to the test against a tough transplant complication
- Why COVID-19 hits blood cancer patients harder: scientists map the immune clues
- Can adding rituximab improve remission in chronic GVHD?
- Softer chemo before stem cell transplant aims to cure blood cancers in frail children