Trial · NCT03927222
Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma
NCT03927222, Phase 2, Terminated, Mustafa Khasraw, MBChB, MD, FRCP, FRACP; results first posted 2024-04-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma. Trials, record NCT03927222. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03927222
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma
- NCT number
- NCT03927222
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Mustafa Khasraw, MBChB, MD, FRCP, FRACP
- Conditions
- Glioblastoma
- Interventions
- Human CMV pp65-LAMP mRNA-pulsed autologous DCs containing GM CSF, Temozolomide, Tetanus-Diphtheria Toxoid (Td), GM-CSF, 111-Indium-labeling of Cells for in vivo Trafficking Studies
- First posted
- 2019-04-25
- Last updated
- 2024-04-08
- Results first posted
- 2024-04-08
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Overall Survival (OS) of Subjects Receiving Td Pre-conditioning With GM-CSF | duration of the study (up to 3 years and 4.5 months) | Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up has OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve. |
| Secondary | Migration and Survival From Vaccine 4 | 5 years | The Cox proportional hazards model will assess the impact of migration on survival after vaccine #4. Migration is defined as the maximum percentage of 111In-labeled dendritic cells (DCs) reaching inguinal nodes during the 48 hours after the 4th vaccination. The hazard ratio associated with a 1-unit change in migration will be estimated with 95% confidence intervals.CSF to site-draining inguinal lymph nodes after Td pre-conditioning and survival after vaccine # 4. |
| Secondary | Chemokine (C-C Motif) Ligand 3 (CCL3) and Survival From Vaccine 4 | 5 years | The Cox proportional hazards model will assess the impact of CCL3 on survival post-vaccine 4. The hazard ratio associate with a 1-unit increase in CCL3 will be estimated with 95% confidence intervals |
| Secondary | Polyfunctionality and Survival From Vaccine 4 | 5 years | Cox proportional hazards model will assess the association between fold change increase between baseline and the leukapheresis 2 in the frequency of pp65 antigen-specific CD8+ T cells producing three or more cytokines (IFNγ, CCL3, IL-2, TNFα, CD107a), and survival post-vaccine 4. The hazard ratio associate with a 1-unit fold change in polyfunctionality will be estimated with 95% confidence intervals. |
| Secondary | Maximum Peak Increase From Vaccine 1 in Percent Regulatory T Cells (TReg) of CD4+ T Cells | 1 year | The mean difference in TRegs between vaccine 1 and the maximum measured level post-vaccine 1 will be reported. |
| Secondary | Number of Participants With Unacceptable Toxicity | 1 year | An unacceptable toxicity is defined as any grade 3 or greater toxicity that is possibly, probably, or definitely attributed to the pre-conditioning agent Td or pp65 DC vaccine that does not resolve to baseline within 3 weeks; any Grade 3 hypersensitivity reactions or autoimmune toxicity requiring steroids or hormone replacement; , and is not due to progressive disease, or any life-threatening event not attributable to concomitant medication, co-morbid event, or disease progression. Toxicities will be graded according to the National Cancer Institute Common Toxicity Criteria of Adverse Events (NCI CTCAE) version 5 criteria. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Overall Survival (OS) of Subjects Receiving Td Pre-conditioning With GM-CSF | duration of the study (up to 3 years and 4.5 months) | months | MEDIAN | |
| SECONDARY | Migration and Survival From Vaccine 4 | 5 years | Data not collected. | ||
| SECONDARY | Chemokine (C-C Motif) Ligand 3 (CCL3) and Survival From Vaccine 4 | 5 years | Data not collected. | ||
| SECONDARY | Polyfunctionality and Survival From Vaccine 4 | 5 years | Data not collected. | ||
| SECONDARY | Maximum Peak Increase From Vaccine 1 in Percent Regulatory T Cells (TReg) of CD4+ T Cells | 1 year | Data not collected. | ||
| SECONDARY | Number of Participants With Unacceptable Toxicity | 1 year | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Overall Survival (OS) of Subjects Receiving Td Pre-conditioning With GM-CSF | DC Vaccination With Td Preconditioning and GM CSF | 17.4 | 95% Confidence Interval 13.3 to NA | months | |
| Number of Participants With Unacceptable Toxicity | DC Vaccination With Td Preconditioning and GM CSF | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DC Vaccination With Td Preconditioning and GM CSF | 6 | |
| Overall Study | COMPLETED | DC Vaccination With Td Preconditioning and GM CSF | 0 | |
| Overall Study | NOT COMPLETED | DC Vaccination With Td Preconditioning and GM CSF | 6 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Agitation | Psychiatric disorders | DC Vaccination With Td Preconditioning and GM CSF | 1 | 6 | |
| other | Alanine aminotransferase increased | Investigations | DC Vaccination With Td Preconditioning and GM CSF | 1 | 6 | |
| other | Allergic reaction | Immune system disorders | DC Vaccination With Td Preconditioning and GM CSF | 1 | 6 | |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | DC Vaccination With Td Preconditioning and GM CSF | 2 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | DC Vaccination With Td Preconditioning and GM CSF | 4 | 6 | |
| other | Anorexia | Metabolism and nutrition disorders | DC Vaccination With Td Preconditioning and GM CSF | 4 | 6 | |
| other | Anxiety | Psychiatric disorders | DC Vaccination With Td Preconditioning and GM CSF | 1 | 6 | |
| other | Atrial fibrillation | Cardiac disorders | DC Vaccination With Td Preconditioning and GM CSF | 1 | 6 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | DC Vaccination With Td Preconditioning and GM CSF | 1 | 6 | |
| other | Blood bilirubin increased | Investigations | DC Vaccination With Td Preconditioning and GM CSF | 2 | 6 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DC Vaccination With Td Preconditioning and GM CSF | 5 | 6 |
| Total, other adverse events | DC Vaccination With Td Preconditioning and GM CSF | 6 | 6 |
| Total, serious adverse events | DC Vaccination With Td Preconditioning and GM CSF | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03927222
GET https://conductscience.org/api/trials/v1/NCT03927222/events?page=2