Dose Escalation Study in Patients With Relapsed or Refractory DLBCL and MyD88 L265P Mutation
Public ClinicalTrials.gov record NCT02252146. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I/II Open-label, Multiple-dose, Dose-escalation Study to Evaluate the Safety and Tolerability of IMO-8400 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Presence of the MyD88 L265P Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 30% of the patients with the activated B-cell (ABC) type of Diffuse Large B Cell Lymphoma (DLBCL). MYD88 is an initial adapter linker protein in the signaling pathway of the Toll Like Receptors (TLRs), including the endosomal TLRs 7, 8, and 9, for which the ligands are nucleic acids. IMO-8400 is an oligonucleotide specifically designed to inhibit ligand activation of TLRs 7,8, and 9. Recent studies indicate that in the presence of L265P mutation ligand activation of those TLRs results in markedly increased signaling with subsequent increased cell activation, cell survival, and cell proliferation. The scientific rationale for assessing the use of IMO-8400 to treat patients with DLBCL and the L265P mutation is based on laboratory observations that IMO-8400 inhibits ligand-based activation of cells with the mutation and decreases the survival and proliferation of the cell populations responsible for the propagation of the disease.
Study identification
- NCT ID
- NCT02252146
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 6 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2014
- Primary completion
- Nov 30, 2016
- Completion
- Nov 30, 2016
- Last update posted
- Dec 11, 2017
2014 – 2016
United States locations
- U.S. sites
- 12
- U.S. states
- 12
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90095 | — |
| Emory University | Atlanta | Georgia | 30306 | — |
| Cancer Care Specialists of Illinois | Decatur | Illinois | 62526 | — |
| Horizon Bio Advance | Lafayette | Indiana | 47905 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Columbia University Medical Center | New York | New York | 10019 | — |
| Cleveland Clinic | Cleveland | Ohio | 44109 | — |
| Vanderbilt Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02252146, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 11, 2017 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02252146 live on ClinicalTrials.gov.