Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 80 Years|
- - DONOR: Ability to comprehend the investigational nature of the study and provide informed consent.
- - DONOR: Willing to receive Triplex vaccination, a minimum of 14 days prior to the PBSC collection.
- - DONOR VACCINATION: Donors are eligible to be vaccinated prior to the determination of their human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and human T-cell lymphotropic virus (HTLV) status.
- - RECIPIENT: All subjects must have the ability to understand and the willingness to sign a written informed consent.
- - RECIPIENT: Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT.
- - RECIPIENT: Age 18 to 75 years.
- - RECIPIENT: Planned HCT for the treatment of the following hematologic malignancies: lymphoma (Hodgkin and non-Hodgkin), myelodysplastic syndrome, acute lymphoblastic leukemia in first or second remission, acute myeloid leukemia in first or second remission, chronic myelogenous leukemia (in first chronic or accelerated phase, or in second chronic phase), chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis (City of Hope [COH] only).
- - RECIPIENT: CMV seropositive.
- - RECIPIENT: Planned related HCT with 8/8 (A, B, C, DRB1) high resolution HLA donor allele matching.
- - RECIPIENT: Conditioning and immunosuppressive regimens according to institutional guidelines are permitted.
- - RECIPIENT: Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) within two weeks of registration.
- - RECIPIENT: Seronegative for HIV, HCV and active HBV (surface antigen negative) within 2 months of registration.
- - RECIPIENT: Agreement by females of childbearing potential and males with partners of childbearing potential to use effective contraception (hormonal or barrier method or abstinence) prior to study entry and for up to 90 days post-HCT.
- - TRANSPLANT FROM DONOR: Unfit to undergo standard stem cell mobilization and apheresis e.g. abnormal blood counts, history of stroke, uncontrolled hypertension.
- - TRANSPLANT FROM DONOR: Sickling hemoglobinopathy including HbSS, HbAS, HbSC.
- - TRANSPLANT FROM DONOR: Positive for human immunodeficiency virus (HIV), active hepatitis B (hepatitis B virus [HBV]), hepatitis C (hepatitis C virus [HCV]) or human T-cell lymphotropic virus (HTLV-I/II).
- - TRANSPLANT FROM DONOR: Donors with impaired cardiac function are excluded.
- - TRANSPLANT FROM DONOR: Severe psychiatric illness.
- - RECIPIENT: Any prior investigational CMV vaccine.
- - RECIPIENT: Experimental anti-CMV chemotherapy in the last 6 months.
- - RECIPIENT: Planned medications from the time of HCT to day 70 post-HCT.
- - RECIPIENT: Live attenuated vaccines.
- - RECIPIENT: Medically indicated subunit (Engerix-B for HBV; Gardasil for human papillomavirus [HPV]) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections) - RECIPIENT: Allergy treatment with antigens injections.
- - RECIPIENT: Alemtuzumab or any equivalent in vivo T-cell depleting agent.
- - RECIPIENT: Antiviral medications with known therapeutic effects on CMV such as ganciclovir (GCV)/valganciclovir (VAL), FOS, Cidofovir, CMX-001, maribavir.
- - RECIPIENT: Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment (Letermovir is permitted).
- - RECIPIENT: Other investigational product - concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited.
- - RECIPIENT: Other medications that might interfere with the evaluation of the investigational product.
- - RECIPIENT: Diagnosis with autoimmune disease.
- - RECIPIENT: Pregnant women and women who are lactating.
- - RECIPIENT: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., social/ psychological issues, etc.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|City of Hope Medical Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Ryotaro Nakamura, MD|
|Principal Investigator Affiliation||City of Hope Medical Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia in Remission, Chronic Lymphocytic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Cytomegalovirus Positive, Donor, Hematopoietic Cell Transplant Recipient, Hodgkin Lymphoma, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasm, Non-Hodgkin Lymphoma, Myelofibrosis, Hematopoietic and Lymphoid Cell Neoplasm|
- I. Establish the feasibility and safety of priming CMV immunity in donors by Triplex vaccination prior to peripheral blood stem cell (PBSC) harvest.
- I. Examine if Triplex vaccination of hematopoietic stem cell transplant (HCT) donors has an impact on CMV events.
Experimental: Prevention(multi-peptide CMV-modified vaccinia Ankara vaccine)
Donors receive multi-peptide CMV-modified vaccinia Ankara vaccine injection between days -60 and -10 prior to granulocyte colony stimulating factor mobilization. Participants undergo hematopoietic cell transplantation on day 0.
Biological: - Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
Given via injection
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.