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A Phase II Study of Visilizumab for the Prevention of Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation

Phase 2
18 Years
60 Years
Open (Enrolling)
Graft Versus Host Disease

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Trial Information

A Phase II Study of Visilizumab for the Prevention of Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation

This protocol is a two stage, controlled, phase II study, to assess safety and compare the
grade of acute graft-versus-host disease (GVHD) with visilizumab or thymoglobulin (ATG) in
combination with tacrolimus + methotrexate in patients at high risk of GVHD after transplant
from unrelated donors mismatched for 1-2 alleles of any type at HLA A, B, C and DRB1.

The study design includes two stages. The first stage of the trial will enroll 15 patients
on a single arm to be treated with "study treatment" (visilizumab, tacrolimus and
methotrexate) to assess for treatment safety and exclude intolerable GVHD. The second stage
of the trial includes a random control group of patients treated with the current "standard
treatment" (ATG, tacrolimus, and methotrexate) or "study treatment". The purpose of this
comparison is to determine if the "study treatment" visilizumab causes less severe side
effects and if it is more potent in reducing graft-versus-host disease symptoms than the
"standard treatment".

In addition, immunological studies will be conducted to test the pharmacokinetics,
immunogenicity, and pharmacodynamics of visilizumab or ATG administered for GVHD prophylaxis
after hematopoietic cell transplantation.

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 (CR) 1 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 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: DLCO (corrected for Hgb), FEV1, 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

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 HSC transplantation, confirmed by NAT

- Uncontrolled bacterial or fungal infection

- History of documented invasive aspergillosis or 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

To assess whether the grade of acute GVHD is decreased by visilizumab in combination with tacrolimus/methotrexate compared to standard treatment with thymoglobulin/tacrolimus/methotrexate after transplantation from unrelated mismatched donors.

Outcome Time Frame:

Day of transplant up to one year

Safety Issue:


Principal Investigator

Lia Perez, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

July 2013

Related Keywords:

  • Graft Versus Host Disease
  • graft versus host disease
  • GVHD
  • allogeneic transplant
  • GVHD prevention
  • unrelated donors
  • mismatched unrelated donors
  • hematological malignancies
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndrome
  • Myelofibrosis
  • Aplastic Anemia
  • Multiple Myeloma
  • Graft vs Host Disease



H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612