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Gardasil 9 Vaccine in Preventing HPV Infection in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant

StatusActive, Not Recruiting
PhasePhase 4
Started2017-04-23
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 16, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 2 months later Jul 31, 2026 → Sep 30, 2026
See other at-risk trials from M.D. Anderson Cancer Center

Amendment history

2026-07-15
Study Status v22
Primary completion pushed: 2026-07-31 → 2026-09-30
Completion pushed: 2026-07-31 → 2026-09-30
2026-05-18
2 amendments v20-v21
2 re-verifications since 2025-11-17, no change to tracked fields
2025-05-14
Study Status v19
Primary completion date2025-05-31→2026-07-31
Completion date2025-05-31→2026-07-31
2025-04-22
Study Identification, Study Status v18
Study titlerevised
Gardasil 9 Vaccine in Preventing HPV Infection in Patients withWith Hematologic Malignancies Undergoing Donor Stem Cell Transplant
2024-10-28
Study Identification, Study Status v17
Study titlerevised
Gardasil 9 Vaccine in Preventing HPV Infection in Patients Withwith Hematologic Malignancies Undergoing Donor Stem Cell Transplant
Show 16 earlier versions
2024-04-24
Study Status v16
Primary completion date2024-05-31→2025-05-31
Completion date2024-05-31→2025-05-31
2023-12-06
2 amendments v14-v15
2 re-verifications since 2023-11-06, no change to tracked fields
2023-06-29
Study Status v13
Primary completion date2023-05-31→2024-05-31
Completion date2023-05-31→2024-05-31
2022-06-29
Study Status v12
Primary completion date2022-05-31→2023-05-31
2021-11-17
Study Status v11
Re-verified, no change to tracked fields
2021-02-26
Recruiting→Active, Not Recruiting Study Identification, Study Status, Study Design, Contacts/Locations v10
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2020-04-30→2022-05-31
Completion date2020-04-30→2023-05-31
Study sitesdetails revised at 1 of 1 site
2020-03-13
2 amendments v8-v9
2 re-verifications since 2019-06-03, no change to tracked fields
2019-05-30
Study Status v7
Primary completion date2019-04-30→2020-04-30
Completion date2019-04-30→2020-04-30
2018-11-19
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, References v6
Primary completion date2019-04→2019-04-30
Completion date2019-04→2019-04-30
InterventionsGARDASIL 9 (Biological)→Recombinant Human Papillomavirus Nonavalent Vaccine (Biological)
Eligibility criteria-28 characters
Inclusion Criteria: All English-speaking adult (18 years and older) MD Anderson patients with hematologic malignancy at 6-12 mo [...] ho will receive usual post-stem cell transplant vaccinations. All patients from approved protocol 2015-0795 will be invited to this vaccine study. Exclusion Criteria: Prior allogeneic SCT Platelet count less than or equal to 25,000 K/µL.uL Absolute neutrophil count less than or equal to 500/µL.uL Patients who have ever received HPV vaccination (at least one dose of HPV vaccine). Patients with a prior history of HPV-related malignancy. Female patients who tested positiv [...] [...]
Secondary endpoints1 to 4 entries
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Antibody Persistencepersistence at 6 Monthsmonths Postpost-Dosedose 3 Human Comparedpapillomavirus with(HPV) 1vaccination Monthcompletion Post-Doserate Estimation 3of antibody titers
Primary endpoints2 to 1 entries
Antibody Response Safetyresponse anddefined Tolerabilityas numerically elevated antibody titer of GARDASILany 9type measuredat by1 Adversemonth eventspost-dose 3 (month 7)
Study description-961 characters
IfPRIMARY participantOBJECTIVES: I. agreesTo todetermine takethe partimmunogenicity of recombinant human papillomavirus nonavalent vaccine (GARDASIL 9) administered after allogeneic stem cell transplant (SCT) in thispatients study,with abouthematologic malignancy by comparing HPV 9-plex competitive Luminex immunoassay (9-plex cLIA) titers before and after GARDASIL 9 administration. II. To evaluate the safety and tolerability of GARDASIL 9 administered after allogeneic SCT in patients with hematologic malignancy. OUTLINE: Patients undergo standard [...] 6-12 months after their stem cell transplant: P [...] [...]
Study sites1 entry, revised
UniversityM of Texas MDD Anderson Cancer Center
Collaborators3 to 1 entries
Merck Sharp & Dohme LLC UniversityNational Cancer Foundation Duncan Family Institute for Cancer Prevention and Risk Assessment(NCI)
Study title+17 characters
HPV Antibody Response After GARDASILGardasil 9 VaccinationVaccine in ParticipantsPreventing AfterHPV AllogeneicInfection in Patients With Hematologic Malignancies Undergoing Donor Stem Cell TransplantationTransplant
2018-06-20
2 amendments v4-v5
2 re-verifications since 2017-10-26, no change to tracked fields
2017-04-24
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2019-06→2019-04
Completion date2019-06→2019-04
Start dateestimated 2017-06→confirmed 2017-04-23
Study sitesdetails revised at 1 of 1 site
2017-04-19
Study Status, Contacts/Locations v2
Study sitescontacts updated at 1 of 1 site
2017-03-20
Study Status, Oversight, Study Design v1
Primary completion date2019-02→2019-06
Completion datenot stated→2019-06
Start date2017-02→2017-06
2017-01-17
Original filing
This phase IV trial studies how well Gardasil 9 vaccine works in preventing human papillomavirus (HPV) infection in patients with hematologic malignancies who are undergoing donor stem cell transplant. Vaccines, such as Gardasil 9, may help the body build an effective immune response to kill cancer cells.
Trial Details
NCT Number NCT03023631
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Allogeneic Hematopoietic Stem Cell Transplant Recipient, Hematopoietic and Lymphoid Cell Neoplasm
Enrollment 48 participants
Start Date 2017-04-23
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-16