Status:
COMPLETED
Dose Escalation Study in Patients With Relapsed or Refractory DLBCL and MyD88 L265P Mutation
Lead Sponsor:
Idera Pharmaceuticals, Inc.
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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)....
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02252146
Start Date
June 1 2014
End Date
December 1 2016
Last Update
December 12 2017
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
UCLA Medical Center
Los Angeles, California, United States, 90095
2
Emory University
Atlanta, Georgia, United States, 30306
3
Cancer Care Specialists of Illinois
Decatur, Illinois, United States, 62526
4
Horizon Bio Advance
Lafayette, Indiana, United States, 47905