2024-01-09
minor
Study Identification, Study Status, Conditions, Study Design, Arms and Interventions, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v14
PhasePhase 2→Phase 1
Primary completion dateestimated 2023-12-18→confirmed 2022-01-22
Completion date2023-12-18→2024-06-18
Results first postednot stated→2024-01-31
Study arms1→2
Secondary endpoints-14 characters
CMV protection
Primary endpoints7 to 5 entries
100-Day Non-Relapse Mortality (NRM)
Delayed engraftmentEngraftment
Feasibility assessed by numberNumber of suitableDonors donor/recipientWith pairsGrade were2-3 approached,Adverse andEvents
Number theof numberRecipients thatWith were successfully enrolled/vaccinated
Grade 3-4 AEs
IncidenceAdverse of adverse events (AEs)
Non-relapse mortalityEvents
Severe acute(Grade graftIII-IV) versusAcute hostGraft diseaseVersus (aGVHD)
TherapyHost induced quantitative/kinetic changes in cytomegalovirus (CMV)-specific cellular immunityDisease
Study title-29 characters
CMV-MVA Triplex Vaccination of Stem Cell Donors in Preventing CMV Viremia in Participants With Blood Cancer Undergoing Donor Stem CellAllogeneic Transplant
Show 13 earlier versions
2023-04-04
minor
Study Status v13
Primary completion date2023-03-18→2023-12-18
Completion date2023-03-18→2023-12-18
2022-09-28
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v12
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 36→confirmed 34
Study sitesdetails revised at 1 of 1 site
2022-08-15
minor
Study Status v11
Re-verified, no change to tracked fields
2021-08-11
minor
Study Status v10
Primary completion date2021-03-18→2023-03-18
Completion date2021-03-18→2023-03-18
2020-12-15
minor
Study Status v9
Re-verified, no change to tracked fields
2020-04-02
minor
Study Status v8
Primary completion date2020-03-18→2021-03-18
Completion date2020-03-18→2021-03-18
2019-07-30
minor
Study Status, Study Description, Conditions, Arms and Interventions, Eligibility v7
Primary completion date2019-10-18→2020-03-18
Completion date2019-10-18→2020-03-18
Eligibility criteria+181 characters
[...] cination, a minimum of 14 days prior to the PBSC collection
DAY 28 DONOR VACCINATION: Donors are eligible to be vaccinated prio [...] virus [HCV]) or human T-cell lymphotropic virus (HTLV-I/II).
This holds true even if donors have been already vaccinated according to criteria for donor vaccination
TRANSPLANT FROM DONOR: Donors with impaired cardiac function [...] ophylactic antiviral CMV treatment (Letermovir is permitted).
EXCEPT for low risk patients [8/8 high resolution HLA donor allele matching HCT])
RECIPIENT: Other investigational product - concurrent enroll [...]
Study descriptionrevised
[...] ied vaccinia Ankara vaccine injection between days -60 and -1410 prior to granulocyte colony stimulating factor mobilization [...]
2019-03-15
minor
Study Status, Eligibility v6
Eligibility criteria+470 characters
[...] cination, a minimum of 14 days prior to the PBSC collection
DAY 28 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.
The exclusion criteria for transplant is independent of eligibili [...] RECIPIENT: All subjects must have the ability to understand [...] form her treating physician immediately
Exclusion Criteria:
TRANSPLANT FROM DONOR: Unfit to undergo standard stem cell mobilization and [...] blood counts, history of stroke, uncontroll [...]
2018-11-23
minor
Study Status, Conditions, Eligibility v5
Eligibility criteriarevised
[...] PIENT: CMV seropositive
RECIPIENT: Planned related HCT with 68/68 (A, B, C, DRB1) high resolution HLA donor allele matching
R [...]
2018-08-24
minor
Study Status, Eligibility v4
Eligibility criteria-43 characters
[...] eive Triplex vaccination, a minimum of 14 days prior to the startPBSC of granulocyte stimulating factor (GSF) mobilizationcollection
RECIPIENT: All subjects must have the ability to understand [...]
2018-08-24
minor
Study Status v3
Start dateestimated 2018-10-18→confirmed 2018-08-20
2018-07-11
notable
Not Yet Recruiting→Recruiting Study Status, Study Design, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2019-08-18→2019-10-18
Completion date2019-08-18→2019-10-18
Start date2018-08-18→2018-10-18
Study sitesdetails revised at 1 of 1 site
2018-06-18
minor
Study Status, Outcome Measures, Eligibility v1
Eligibility criteriarevised
[...] rticipant 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 [...] ollowing hematologic malignancies: lymphoma (Hodgkin and non?-Hodgkin), myelodysplastic syndrome, acute lymphoblastic leuk [...] elines are permitted
RECIPIENT: Negative serum or urine beta?-human chorionic gonadotropin (HCG) test (female patient of c [...] abstinence) prior to study entry and for up to 90 days post?-HCT.
Should a woman become pregnant or suspect that she is p [...] rus [HBV]), hepatitis C (hepatitis C viru [...]
Primary endpoints7 entries, revised
Grade 3?-4 AEs
Non?-relapse mortality
Therapy induced quantitative/kinetic changes in cytomegalovirus (CMV)?-specific cellular immunity