Phase 2
N=51
Tildrakizumab for Prevention of Acute Graft-Versus-Host Disease
Hematologic Malignancies
Bottom Line
View on ClinicalTrials.gov: NCT04112810 ↗Enrolled (actual)
51
Serious AEs
22.0%
Results posted
Jul 2025
Primary outcome: Primary: GVHD-free Relapse-Free Survival — 19.3 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tildrakizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY GVHD-free Relapse-Free Survival |
19.3 | — |
| SECONDARY Incidence of Chronic GVHD |
53.7 | — |
| SECONDARY Incidence of Chronic GVHD |
53.7 | — |
| SECONDARY Incidence of Acute GVHD |
14; 18; 4; 4 | — |
| SECONDARY Incidence of Acute GI GVHD |
6; 10.3; 4; 4 | — |
| SECONDARY Primary Graft Failure. |
— | — |
| SECONDARY Secondary Graft Failure |
— | — |
| SECONDARY Hematopoietic Recovery According to Neutrophil Count Recovery |
50 | — |
| SECONDARY Hematopoietic Recovery According to Platelet Count Recovery |
47 | — |
| SECONDARY Non-relapsed Mortality. |
2; 8 | — |
| SECONDARY Disease Relapse or Progression |
14; 14 | — |
| SECONDARY The Number of Subjects With Progression-free Survival. |
84; 78 | — |
| SECONDARY The Number of Subjects With Overall Survival. |
98; 80 | — |
| SECONDARY Incidence of Infections |
14; 16; 20.3 | — |
Summary
This is a phase 2 open-label trial designed to evaluate the efficacy of tildrakizumab in improving graft-versus-host disease (GVHD)-free relapse-free survival after myeloablative allogeneic hematopoietic cell transplantation (alloHCT) for hematologic malignancy.
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years.
- Patients with any hematologic malignancy for which alloHCT is indicated. Patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) must be in complete remission at the time of alloHCT ( 8 mg/kg oral or >6.4 mg/kg intravenous).
- T cell-replete peripheral blood graft.
- Patients must have a matched related or unrelated donor (at least 6/6 match at human leukocyte antigen (HLA) -A, -B and -C for related donors and at least 8/8 match at HLA -A, -B, -C and -DRB1 for unrelated donors).
- Cardiac function: Left ventricular ejection fraction ≥45% for myeloablative conditioning.
- Estimated creatinine clearance ≥40 mL/minute (using the Cockcroft-Gault formula and actual body weight).
- Pulmonary function: diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% (adjusted for hemoglobin) and forced expiratory volume in 1 second (FEV1) ≥50%.
- Liver function: total bilirubin or = 2.
- Patients with uncontrolled bacterial, viral or fungal infections (currently on treatment and with progression of infectious disease or no clinical improvement) at time of enrollment.
- Active hepatitis B or C virus infection or known human immunodeficiency virus (HIV) positive.
- Use of rituximab, alemtuzumab, anti-thymocyte globulin (ATG) or other monoclonal antibody planned as part of conditioning regimen for GVHD prophylaxis.
- Participation in another GVHD prophylaxis clinical trial.
- Any current uncontrolled cardiovascular conditions, including uncontrolled ventricular arrhythmias, New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled angina, or electrocardiographic evidence of active ischemia or active conduction system abnormalities.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
Data sourced from ClinicalTrials.gov (NCT04112810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.