SCCA Lymphoma Clinical Trials
|Recruiting||Waldenstrom's Macroglobulinemia||Phase I/II||
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.
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.
- At least 18 years of age.
- Agree to use contraception
- Is nursing or pregnant
- Has body weight < 50 kg.
- 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 autoimmune cytopenia (anemia, thrombocytopenia, leukopenia).
- Has heart failure of Class III or IV.
- Has sensory or motor neuropathy limiting daily activities.
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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- 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.