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SCCA Lymphoma Clinical Trials

IMO-8400 for Relapsed or Refractory Waldenstrom's Macroglobulinemia (UW14016)
Phase 1/2 Open-Label, Multiple-dose, Dose-escalation Study to Evaluate the Safety and Tolerability of IMO-8400 in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia
Status Conditions Phase Study ID
Recruiting Waldenstrom's Macroglobulinemia Phase I/II UW14016
NCT02092909
Summary

Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 90% of the patients with Waldenström's macroglobulinemia. MYD88 is a key linker protein in the signaling pathway of Toll Like Receptors (TLRs) 7, 8, and 9, and IMO-8400 is an oligonucleotide specifically designed to inhibit TLRs 7,8, and 9. The scientific hypothesis for use of IMO-8400 to treat patients with Waldenström's macroglobulinemia depends on the inhibition of mutant MYD88 signaling in the TLR pathway, thereby interrupting the proliferation of cell populations responsible for the propagation of the disease.


Investigator
Edward N. Libby, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

Patients must have a diagnosis of Waldenstrom's Macroglobulinemia that has relapsed after a previous treatment or has shown partial or no response to previous treatment.

In addition to the above, key inclusion and exclusion criteria are listed below.

Inclusion Criteria:

  1. At least 18 years of age.
  2. Agree to use contraception
Exclusions (conditions that would prevent participation in this study)
  1. Is nursing or pregnant
  2. Has body weight < 50 kg.
  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 autoimmune cytopenia (anemia, thrombocytopenia, leukopenia).
  10. Has heart failure of Class III or IV.
  11. Has sensory or motor neuropathy limiting daily activities.
Last Updated
May 22, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.