Dose Escalation Study in Patients With Relapsed or Refractory DLBCL and MyD88 L265P Mutation
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02252146 |
Recruitment Status :
Completed
First Posted : September 30, 2014
Results First Posted : November 14, 2017
Last Update Posted : December 12, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diffuse Large B Cell Lymphoma | Drug: IMO-8400 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | June 2014 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: IMO-8400
IMO-8400 0.3 mg/kg twice weekly, 0.6 mg/kg twice weekly, or 1.2 mg/kg twice weekly
|
Drug: IMO-8400
MO-8400 given subcutaneously twice weekly |
- Number of Participants With Adverse Events, Injection Site Reactions, and Concomitant Medications [ Time Frame: Up to 2 years from first patient visit ]Frequency of adverse events, injection site reactions, and concomitant medications observed

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252146
United States, California | |
UCLA Medical Center | |
Los Angeles, California, United States, 90095 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30306 | |
United States, Illinois | |
Cancer Care Specialists of Illinois | |
Decatur, Illinois, United States, 62526 | |
United States, Indiana | |
Horizon Bio Advance | |
Lafayette, Indiana, United States, 47905 | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02215 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, Missouri | |
Washington University | |
Saint Louis, Missouri, United States, 63110 | |
United States, New Jersey | |
Hackensack University Medical Center | |
Hackensack, New Jersey, United States, 07601 | |
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10019 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44109 | |
United States, Tennessee | |
Vanderbilt Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Study Director: | Mark Cornfeld, MD, MPH | Idera Pharmaceuticals, Inc. |
Documents provided by Idera Pharmaceuticals, Inc.:
Additional Information:
Responsible Party: | Idera Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT02252146 History of Changes |
Other Study ID Numbers: |
8400-402 |
First Posted: | September 30, 2014 Key Record Dates |
Results First Posted: | November 14, 2017 |
Last Update Posted: | December 12, 2017 |
Last Verified: | November 2017 |
DLBCL MYD88 L265P Lymphoma |
Diffuse Large B Cell Lymphoma Idera IMO 8400 |
Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |