Clinical trial · Interventional
Visilizumab for the Prevention of Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation
A Phase II Study of Visilizumab for the Prevention of Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study was to test whether a new drug named visilizumab would decrease the severity of graft-versus-host disease in patients treated with a mismatched donor. Investigators planned to use visilizumab in combination with tacrolimus and methotrexate as the "study treatment".
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graft Versus Host Disease | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antithymocyte globulin (ATG) | Drug | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Tacrolimus | Drug | — | UNRESOLVED |
| Visilizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- First Study Stage: Study Treatment
- description
- Visilizumab, Tacrolimus and Methotrexate.
- interventionNames
- Drug: Visilizumab
- Drug: Tacrolimus
- Drug: Methotrexate
- type
- ACTIVE_COMPARATOR
- label
- Second Study Stage: Standard Treatment
- description
- Second Stage: Antithymocyte-globulin (ATG), Tacrolimus and Methotrexate. The study was closed during first stage and did not proceed to the second stage comparison to ATG in combination with tacrolimus/methotrexate as originally planned.
- interventionNames
- Drug: Antithymocyte globulin (ATG)
- Drug: Tacrolimus
- Drug: Methotrexate
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * One of the following diagnoses with histological confirmation by the Pathology Department at H. Lee Moffitt Cancer Center: * Acute Lymphocytic Leukemia (ALL) in complete remission 1 (CR1) with t(9:22) or t(4:11), or any ALL beyond CR1 * Acute Myelogenous Leukemia (AML) with high risk cytogenetics in CR1 as defined by Bloomfield any AML beyond CR1 * Myelodysplastic Syndrome (MDS) with International Prognostic Scoring System (IPSS) score \> 1 * Chronic myelomonocytic leukemia (CMML) * Chronic Myelogenous Leukemia (CML) with Imatinib-refractory chronic phase, or beyond chronic phase by morphology or cytogenetics * Myelofibrosis * Severe aplastic anemia * Chemosensitive Non-Hodgkin's lymphoma and Hodgkin's disease that are not candidate to autologous transplant due to prior autologous transplantation * Multiple Myeloma patient not candidate for autologous stem cell transplantation * Karnofsky performance status ≥ 70% (adult) * Normal organ and marrow function as defined below: * Hepatic: Total bilirubin must be less than or equal to 2mg/dL (Gilbert and other syndromes with increased indirect bilirubin are allowed); serum transaminases must be less than two times the upper limit of normal * Pulmonary: diffusing capacity of lung for carbon monoxide (DLCO) (corrected for Hgb), forced expiratory volume-one second (FEV1), forced vital capacity (FVC) must be greater than 50% predicted * Cardiac: Left ventricular ejection fraction at rest must be greater than 50% * Renal: Creatinine clearance (measured or calculated) must be equal or greater than 50 ml/min/1.73m\^2 Exclusion Criteria: * Anti thymocyte globulin (ATG) or anti T cell therapy in prior 45 days * Splenectomized patients; * A positive pregnancy test administered to all females of childbearing potential prior to allogeneic stem cell transplant * Inability to comply with follow up as determined by the patient's physician * HIV-I/II infection prior to hematopoietic stem cell (HSC) transplantation, confirmed by nucleic acid test (NAT) * Uncontrolled bacterial or fungal infection * History of documented invasive aspergillosis or cytomegalovirus (CMV) pneumonia * Presence of any of the following comorbid conditions: * History of myocardial infarction * Congestive heart failure (even if symptomatically controlled) * Peripheral vascular disease (including intermittent claudication or history of bypass for arterial insufficiency) * Untreated thoracic or abdominal aneurysm (6cm or more) * History of any cerebrovascular accident including transient ischemic attacks * Dementia * History of peptic ulcer disease requiring treatment * Connective tissue/rheumatologic disorders * Diabetes unless being managed with dietary changes only * Hemiplegia/paraplegia * History of solid tumor excluding skin or cervical carcinoma after curative resection
References
Publications (1)
- DERIVEDPidala J, Perez L, Beato F, Anasetti C. Ustekinumab demonstrates activity in glucocorticoid-refractory acute GVHD. Bone Marrow Transplant. 2012 May;47(5):747-8. doi: 10.1038/bmt.2011.172. Epub 2011 Aug 29. No abstract available. PMID 21874061