Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia

Stopped early · Phase 1/Phase 2

Conditions studied: Waldenstrom's Macroglobulinemia

In brief

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.

Key facts

Study ID

NCT02092909

Run by

Idera Pharmaceuticals, Inc.

People needed

31

Starts

2014-03-01

Expected to finish

2017-11-01

Last updated by the study team

2019-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have a diagnosis of relapsed Waldenstrom's Macroglobulinemia.
• In addition to the above, key inclusion and exclusion criteria are listed below.
• Inclusion Criteria:
• At least 18 years of age.
• Agree to use contraception
• Hemoglobin ≥ 7.5 g/dL, - Absolute neutrophil count ≥ 1.0 x 109/L (1000/mm3), - Platelets ≥ 50,000/μL

You may not qualify if…

• Is nursing or pregnant
• 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, at the initiation of study drug, received cytotoxic chemotherapy or a Bruton's tyrosine kinase (BTK)-inhibitor (e.g. ibrutinib) within the past 3 weeks or rituximab within the past 2 months
• 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.

Where it is running

• Cancer Centers of Excellence — Fayetteville, Arkansas, United States
• UCLA — Los Angeles, California, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Emory Winship Cancer Institute — Atlanta, Georgia, United States
• Horizon BioAdvance — Lafayette, Indiana, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Hackensack University — Hackensack, New Jersey, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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