Dose Escalation Study in Patients With Relapsed or Refractory DLBCL and MyD88 L265P Mutation
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
1 other identifier
interventional
6
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2014
Typical duration for phase_1
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 8, 2014
CompletedFirst Posted
Study publicly available on registry
September 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
November 14, 2017
CompletedDecember 12, 2017
November 1, 2017
2.5 years
August 8, 2014
October 17, 2017
November 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events, Injection Site Reactions, and Concomitant Medications
Frequency of adverse events, injection site reactions, and concomitant medications observed
Up to 2 years from first patient visit
Study Arms (1)
IMO-8400
EXPERIMENTALIMO-8400 0.3 mg/kg twice weekly, 0.6 mg/kg twice weekly, or 1.2 mg/kg twice weekly
Interventions
Eligibility Criteria
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.
You may not qualify if:
- Be at least 18 years of age
- Agree to use contraception
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
UCLA Medical Center
Los Angeles, California, 90095, United States
Emory University
Atlanta, Georgia, 30306, United States
Cancer Care Specialists of Illinois
Decatur, Illinois, 62526, United States
Horizon Bio Advance
Lafayette, Indiana, 47905, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Columbia University Medical Center
New York, New York, 10019, United States
Cleveland Clinic
Cleveland, Ohio, 44109, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Idera Medical Monitor
- Organization
- Idera Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Mark Cornfeld, MD, MPH
Idera Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2014
First Posted
September 30, 2014
Study Start
June 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
December 12, 2017
Results First Posted
November 14, 2017
Record last verified: 2017-11