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NCT03688178 · ClinicalTrials.gov registry record · Phase 2
DC Migration Study to Evaluate TReg Depletion In GBM Patients With and Without Varlilumab
A Phase 2 study of Glioblastoma, sponsored by Annick Desjardins, MD.
- Active
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT03688178: Active Phase 2 study of Glioblastoma, sponsored by Annick Desjardins, MD.
NCT03688178 is a Phase 2 study of Glioblastoma that is active but no longer recruiting, run by Annick Desjardins, MD. The registered enrollment target is 43 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03688178, a Phase 2 study of Glioblastoma, is active but no longer recruiting, sponsored by Annick Desjardins, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with newly diagnosed glioblastoma will be consented following tumor resection then undergo leukapheresis for harvest of peripheral blood leukocytes for generation of dendritic cells. Subjects will then receive standard of care (planned 6 weeks) radiation therapy (RT) and concurrent temozolomide (TMZ) at a standard targeted dose of 75 mg/m2/day. The study cycle of TMZ comprises a targeted dose of 150-200mg/m2/day for 5 days every 4 (+2) weeks for up to 12 cycles (patients with unmethylated MGMT gene promoter will receive only cycle 1). All patients will receive up to a total of 10 DC vaccines called pp65 CMV dendritic cells (DC). Dendritic Cell (DC) vaccines #1-3 will be given every two weeks, thus delaying the initiation of TMZ cycle 2 for patients receiving TMZ. All remaining TMZ/vaccine cycles will be 4 (+2) weeks in length. After the first 3 DC vaccines given during Cycle 1 of TMZ, the remaining DC vaccine injections are given on Day 21 (+/- 2 days) of each TMZ cycle. Subjects with unmethylated MGMT will only receive one cycle of adjuvant TMZ; however, their vaccine schedule will follow the same 4 (+ 2) week TMZ cycle schedule. Following RT, patients will be randomized into 1 of 3 groups. Groups 1 and 2 will be blinded. The groups differ in the type of pre-conditioning received prior to DC vaccine #4; additionally, Group 3 will be receiving infusions of varlilumab 7 days prior to and with vaccine #1 and 7 days prior to vaccine #3+. The pre-conditioning for each group is as follows: Group 1: Unpulsed DC pre-conditioning prior to DC vaccine #4; Group 2: Tetanus-diphtheria (Td) pre-conditioning prior to DC vaccine #4; Group 3: Td pre-conditioning prior to DC vaccine #4 and varlilumab infusion at 7 days prior to each DC vaccine (except DC vaccine #2) with Td pre-conditioning prior to vaccine #4.
Primary Outcome
OS is defined as the time in months between randomization and death, or last follow-up if alive (Groups 1 and 2). Kaplan-Meier methods will be used to estimate median OS
Conditions Studied
Interventions
- DRUG Temozolomide
- BIOLOGICAL Human CMV pp65-LAMP mRNA-pulsed autologous DCs
- BIOLOGICAL Varlilumab
- BIOLOGICAL Td
- BIOLOGICAL Unpulsed DCs
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2020-08-26 |
| Est. Completion | 2026-03 |
| Phase | Phase 2 |
What the registry record for NCT03688178 still lists
NCT03688178 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which Temozolomide is the first listed.
NCT03688178 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03688178 about?
NCT03688178 is a clinical study titled "DC Migration Study to Evaluate TReg Depletion In GBM Patients With and Without Varlilumab". Patients with newly diagnosed glioblastoma will be consented following tumor resection then undergo leukapheresis for harvest of peripheral blood leukocytes for generation of dendritic cells. Subjects will then receive standard of care (planned 6 weeks) radiation therapy (RT) and concurrent temozolo...
What is the current status of trial NCT03688178?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2020-08-26. Estimated completion is 2026-03.
What conditions does trial NCT03688178 study?
This clinical trial studies the following conditions: Glioblastoma.
What interventions are being tested in trial NCT03688178?
The interventions under investigation include: Temozolomide (DRUG), Human CMV pp65-LAMP mRNA-pulsed autologous DCs (BIOLOGICAL), Varlilumab (BIOLOGICAL), Td (BIOLOGICAL), Unpulsed DCs (BIOLOGICAL).
Who is sponsoring clinical trial NCT03688178?
This trial is sponsored by Annick Desjardins, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03688178 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03688178's enrollment target sits among peer trials
43 101st of 199 higher than 99 of 199 other Glioblastoma trials
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