A clinical study (Phase III) to assess the Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT), when compared against placebo in a randomised, double blind manner.
- Conditions
- CMV reactivation after allogeneic stem cell transplantation.MedDRA version: 16.0Level: LLTClassification code 10049107Term: CMV viraemiaSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2013-000903-18-ES
- Lead Sponsor
- Astellas Pharma Global Development, Inc. (APGD)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 514
1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-specific related procedures (including withdrawal of prohibited medication, if applicable).
2. Subject is a male or female subject who is at least 18 years old or the legal age of consent (whichever is greater).
3. Subject is a CMV-seropositive HCT recipient as confirmed by local laboratory at Screening.
4. Subject is planned to undergo either of the following:
a. Sibling Donor Transplant - 7/8 HLA-A, -B, -C, -DRß1 match utilizing high resolution typing or 8/8 HLA-A, -B, -C, -DRß1 match utilizing low or high resolution typing.
b. Unrelated Donor Transplant - 7/8 or 8/8 HLA-A, -B, -C, -DRß1 match utilizing high resolution typing.
5. Subject is scheduled to receive an allogeneic peripheral blood stem cell (PBSC) or bone marrow transplant (BMT) for the treatment of hematologic disorders as indicated in Inclusion Criterion 6.
6. Subject has one of the following underlying diseases
a. Acute myeloid leukemia (AML), with or without a history of myelodysplastic syndrome, in first or second complete remission or in early relapse (< 20% blasts in bone marrow with no circulating blasts in peripheral blood and no extramedullary leukemia).
b. Acute lymphoblastic leukemia (ALL), in first or second complete remission.
c. Acute undifferentiated leukemia (AUL) in first or second complete remission.
d. Acute biphenotypic leukemia in first or second complete remission.
e. Chronic myelogenous leukemia (CML) in either chronic or accelerated phase.
f. Chronic lymphocytic leukemia (CLL).
g. One of the following myelodysplastic syndrome(s) (MDS) defined by the following:
i. Refractory anemia.
ii. Refractory anemia with ringed sideroblasts.
iii. Refractory cytopenia with multilineage dysplasia.
iv. Refractory cytopenia with multilineage dysplasia and ringed sideroblasts.
v. Refractory anemia with excess blasts-1 (5-10% blasts).
vi. Refractory anemia with excess blasts-2 (10-20% blasts).
vii. Myelodysplastic syndrome (MDS), unclassified.
viii. MDS associated with isolated del (5q).
ix. Chronic myelomonocytic leukemia (CMML).
h. Primary or secondary myelofibrosis without leukemic transformation except if Dynamic
International Prognostic Scoring System (DIPSS) category of high or intermediate-2.
i. Lymphoma (including Hodgkin?s) with chemosensitive disease (> 50% response to
chemotherapy).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
1. Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 3 months (90 days) prior to transplant.
2. Subject has planned CMV prophylactic therapy with antiviral drugs or CMV-specific immunoglobulins from Randomization through the Primary Study Period Completion/Day 365 Visit (Visit 14).
3. Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score > 3.
4. Subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C RNA.
5. Donor CMV serostatus is unknown.
6. Subject has received any of the following substances or treatments:
a. Alemtuzumab within 60 days prior to transplant, including conditioning regimen. Subjects for whom treatment with alemtuzumab is planned at any time from 60 days prior to through one year post-transplant should not be enrolled in the trial.
b. T cell depletion of donor cell product.
c. Administration of a CMV vaccine, including any prior exposure to ASP0113.
7. Subject has received an allogeneic stem cell transplant within one year prior to transplant
(subjects who have received a prior autologous transplant are allowed).
8. Subject has a current malignancy in addition to the malignancy being treated for the study
or the subject has a history of any other malignancy (within the past 5 years prior to Screening) except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully or cancer in situ of the cervix uteri that has been handled by local surgery.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method