A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)

Astellas Pharma Global Development, Inc. (APGD)0 个研究点目标入组 500 人开始时间: 2013年5月3日最近更新: 2017年4月10日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 500

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informedconsent 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.*
•* A minimum of 8 allele matching is required. Subjects with matches performed at more than 8 allelles are included if they have 7/8 or 8/8 match at the HLA-A, -B, -C. –DRß1 allelles.
•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 with evidence of dysplasia.
•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).
•7. Female subject must be either:
•* Of non-child bearing potential:
•o post-menopausal (defined as at least 1 year without any menses)
•prior to Screening and if < 50 years of age and not documented to be surgically sterile must have a negative urine or serum pregnancy test at screening, or
•o documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening).
•Or, if of childbearing potential:
•o must have a negative urine or serum pregnancy test at Screening,
•o if heterosexually active, must use at least one form of birth control*
•(which must be a barrier method) starting at Scre

排除标准

•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 (V 14).
•3. Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score = 4.
•4. Subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C RNA polymerase chain reaction (PCR).
•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.
•9. Subject has an unstable medical or psychiatric condition, including a history of illicit drug(s) or alcohol abuse that the Investigator believes will interfere with protocol requirements.
•10. Subject has had an allergic reaction to any component of the vaccine. Subject has had an allergic reaction to aminoglycosides as kanamycin is used in the manufacturing process of the vaccine.
•11. Subject has participated in any interventional clinical study or has been treated with any investigational research products within 30 days or 5 halflives, whichever is longer, prior to the initiation of Screening.
•(Investigational research products are considered those products that have not been approved for any indication in the country where the subject is enrolled. New regimens of approved chemotherapeutic drugs or antibodies, conditioning drugs, irradiation and T-cell depleting antibodies, except alemtuzumab, are allowed.)
•12. Subject has received a prior HCT and has residual cGVHD.
•13. Subject who is scheduled to have a cord blood transplant or a haploidentical transplant.
•14. Subject has a platelet count of less than 50,000 mm3 within 3 days prior to randomization (platelet transfusions are allowed). Results received in an equivalent local unit of measure must be converted to SI units.
•15. Subject has aplastic anemia or multiple myeloma.
•16. For sites in Japan only: Other subjects considered ineligible by the Investigator/sub-Investigator.

研究者

发起方

Astellas Pharma Global Development, Inc. (APGD)

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