Dose Escalation Study in Patients With Relapsed or Refractory DLBCL and MyD88 L265P Mutation
Completed · Phase 1/Phase 2
Conditions studied: Diffuse Large B Cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT02252146
- Run by
- Idera Pharmaceuticals, Inc.
- People needed
- 6
- Starts
- 2014-06-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2017-12-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have a diagnosis of Diffuse Large B Cell Lymphoma (DLBCL) of non-GCB subtype, established according to the World Health Organization (WHO) criteria that has been tested for the MyD88 L265P mutation.
- In addition to the above, key inclusion and exclusion criteria are listed below.
- Be at least 18 years of age
- Agree to use contraception
You may not qualify if…
- Is nursing or pregnant
- DLBCL of GCB subtype
- Has BMI > 34.9 kg/m2
- Has a positive test for human immunodeficiency virus (HIV-1 or -2) hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg)
- Receiving chronic systemic corticosteroid therapy > 20 mg of prednisone daily
- Being treated with other anti-cancer therapies (approved or investigational)
- Has an active infection requiring systemic antibiotics
- Has had surgery requiring general anesthesia within 4 weeks of starting the study
- Has heart failure of Class III or IV
Where it is running
- UCLA Medical Center — Los Angeles, California, United States
- Emory University — Atlanta, Georgia, United States
- Cancer Care Specialists of Illinois — Decatur, Illinois, United States
- Horizon Bio Advance — Lafayette, Indiana, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Washington University — St Louis, Missouri, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- Columbia University Medical Center — New York, New York, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States
- MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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