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Dose Escalation Study in Patients With Relapsed or Refractory DLBCL and MyD88 L265P Mutation

Primary Purpose

Diffuse Large B Cell Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IMO-8400
Sponsored by
Idera Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma focused on measuring DLBCL, MYD88 L265P, Lymphoma, Diffuse Large B Cell Lymphoma, Idera, IMO 8400

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

    1. Be at least 18 years of age
    2. Agree to use contraception

Exclusion Criteria:

  1. Is nursing or pregnant
  2. DLBCL of GCB subtype
  3. Has BMI > 34.9 kg/m2
  4. Has a positive test for human immunodeficiency virus (HIV-1 or -2) hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg)
  5. Receiving chronic systemic corticosteroid therapy > 20 mg of prednisone daily
  6. Being treated with other anti-cancer therapies (approved or investigational)
  7. Has an active infection requiring systemic antibiotics
  8. Has had surgery requiring general anesthesia within 4 weeks of starting the study
  9. Has heart failure of Class III or IV

Sites / Locations

  • UCLA Medical Center
  • Emory University
  • Cancer Care Specialists of Illinois
  • Horizon Bio Advance
  • Dana-Farber Cancer Institute
  • Mayo Clinic
  • Washington University
  • Hackensack University Medical Center
  • Columbia University Medical Center
  • Cleveland Clinic
  • Vanderbilt Ingram Cancer Center
  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMO-8400

Arm Description

IMO-8400 0.3 mg/kg twice weekly, 0.6 mg/kg twice weekly, or 1.2 mg/kg twice weekly

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events, Injection Site Reactions, and Concomitant Medications
Frequency of adverse events, injection site reactions, and concomitant medications observed

Secondary Outcome Measures

Full Information

First Posted
August 8, 2014
Last Updated
November 13, 2017
Sponsor
Idera Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02252146
Brief Title
Dose Escalation Study in Patients With Relapsed or Refractory DLBCL and MyD88 L265P Mutation
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 Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idera Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Eligible subjects will be enrolled and assigned to one of five dose cohorts. Treatment will be administered by subcutaneous injection until progression or intolerable toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma
Keywords
DLBCL, MYD88 L265P, Lymphoma, Diffuse Large B Cell Lymphoma, Idera, IMO 8400

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMO-8400
Arm Type
Experimental
Arm Description
IMO-8400 0.3 mg/kg twice weekly, 0.6 mg/kg twice weekly, or 1.2 mg/kg twice weekly
Intervention Type
Drug
Intervention Name(s)
IMO-8400
Intervention Description
MO-8400 given subcutaneously twice weekly
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events, Injection Site Reactions, and Concomitant Medications
Description
Frequency of adverse events, injection site reactions, and concomitant medications observed
Time Frame
Up to 2 years from first patient visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Cornfeld, MD, MPH
Organizational Affiliation
Idera Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States
Facility Name
Cancer Care Specialists of Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Horizon Bio Advance
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Vanderbilt Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Dose Escalation Study in Patients With Relapsed or Refractory DLBCL and MyD88 L265P Mutation

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