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A Phase 2 Clinical Trial to Evaluate the Safety, Immunogenicity, and Clinical Benefit of a CMV Immunotherapeutic Vaccine in Donors and CMV-Seropositive Recipients Undergoing Allogeneic, Matched Hematopoietic Cell Transplant (HCT)


Phase 2
18 Years
65 Years
Not Enrolling
Both
Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Acute Myelogenous Leukemia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Myelodysplastic Syndrome

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Trial Information

A Phase 2 Clinical Trial to Evaluate the Safety, Immunogenicity, and Clinical Benefit of a CMV Immunotherapeutic Vaccine in Donors and CMV-Seropositive Recipients Undergoing Allogeneic, Matched Hematopoietic Cell Transplant (HCT)


This study was run by Vical and the record was transferred to Astellas on 1/8/2013.

Trial will enroll up to 240 subjects (160 recipients and 80 donors). Qualified donors and/or
CMV-seropositive recipients (donor/recipient pairs or recipient-only subjects) will be
assigned randomly to receive either a CMV vaccine or a placebo vaccine. Donors will receive
3 vaccines prior to donation and recipients will receive 1 vaccine pretransplant and up to
three vaccines posttransplant. Recipients will be followed for up to 1 year after transplant
to evaluate the safety of the vaccine and to see if there is a clinical benefit in the group
that received the CMV vaccine. The incidence rates of CMV infection, disease, and other
complications from immunosuppression and/or transplantation will be studied.


Inclusion Criteria:



- males and females age 18-65

- 5/6 or 6/6 classic HLA allele-matched donor

- planned GCSF-mobilized peripheral blood stem cell transplant

- CMV-seropositive recipient

- planned transplant with minimal or no T-cell depletion

- Acute Lymphoblastic Leukemia (ALL) in first or second remission; Acute Myeloid
Leukemia (AML) in first or second remission; Chronic Myelogenous Leukemia (CML) in
first chronic or accelerated phase, or in second chronic phase; Hodgkin's and
non-Hodgkin's lymphoma; myelodysplastic syndrome

Exclusion Criteria:

- planned prophylactic cytomegalovirus antiviral therapy

- planned immunosuppression with alemtuzumab (CAMPATH-IH)

- planned prophylactic therapy with CMV immunoglobulin

- autoimmune disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Safety of CMV immunotherapeutic vaccine in donors and recipients undergoing HCT

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Richard T. Kenney, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vical

Authority:

United States: Food and Drug Administration

Study ID:

CB01-202

NCT ID:

NCT00285259

Start Date:

January 2006

Completion Date:

November 2010

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Chronic Myelogenous Leukemia
  • Acute Myelogenous Leukemia
  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Myelodysplastic Syndrome
  • cytomegalovirus infection
  • infectious disease
  • viremia
  • cytomegalovirus disease
  • stem cell transplant
  • allogeneic
  • bone marrow transplant
  • hematopoietic cell transplant
  • Acute Lymphoblastic Leukemia
  • Chronic Myelogenous Leukemia
  • Acute Myelogenous Leukemia
  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Myelodysplastic Syndrome
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Mayo ClinicRochester, Minnesota  55905
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
James Graham Brown Cancer CenterLouisville, Kentucky  40202
Rush University Medical CenterChicago, Illinois  60612-3824
University of Kansas Medical CenterKansas City, Kansas  66160-7353
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Montefiore Medical CenterBronx, New York  10467-2490
Rocky Mountain Cancer CenterDenver, Colorado  80218
City of Hope National Medical CenterLos Angeles, California  91010
Brigham and Women's HospitalBoston, Massachusetts  02115
University of Texas Southwestern Medical Center at DallasDallas, Texas  75235-8897
Baylor University Medical CenterDallas, Texas  75246
Emory UniversityAtlanta, Georgia  30322
University of ChicagoChicago, Illinois  60637
Karmanos Cancer InstituteDetroit, Michigan  48201
University of South FloridaTampa, Florida  33612
Hackensack University Medical Center # 408Hackensack, New Jersey  07601
Roswell Park Cancer Institute CorporationBuffalo, New York  14263
Strong Memorial HospitalRochester, New York  14642
North Carolina Baptist HosptialWinston-Salem, North Carolina  27157