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Protocol No. UW16144

Principal Investigator Callander, Natalie

Phase II (Cancer Control)

Age Group Adult

Scope National

Sponsor Type Industry

Title An Open-Label, Multicenter, Phase 2 Study of CLR 131 in Patients with Relapsed or Refractory (R/R) Select B-Cell Malignancies

Objective This research is being done to help the study sponsor determine if the study drug is safe and can be tolerated for the treatment of multiple myeloma or certain lymphomas. The study drug, CLR131, involved in this clinical trial is considered investigational and not approved by the U.S. Food and Drug Administration (FDA).

Treatment Single dose of CLR 131 25 mCi/m2, no to exceed 2.5 m2 intravenously through a peripheral cite over approximately 30 minutes. Patients may be eligible to receive a second dose of CLR 131

Description This is a multicenter, open-label, Phase 2 study evaluating intravenous (IV) administration of CLR 131 in patients with B-cell malignancies who have been previously treated with standard therapy for their underlying malignancy.

Key Eligibility
  • Histologically or cytologically confirmed MM; CLL/SLL, LPL, MZL; or MCL OR histologically proven, de novo, DLBCL
  • ECOG performance status of 0-2, and 18 years of age or older, life expectancy of at least 6 months
  • Adequate bone marrow, renal, liver and coagulation function.
  • Must be 100 days from stem cell transplant(if applicable)
  • Females and Males of childbearing potential must use reliable form of birth control
  • No prior external-beam RT resulting in greater than 20% of total bone marrow receiving greater than 20 Gy
  • No prior total body or hemi-body irradiation
  • No Central nervous system involvement unless previously treated with surgery or radiotherapy with the patient neurologically stable and off corticosteroids
  • No ongoing chronic immunosuppressive therapy, no clinically significant bleeding event
  • No ongoing anti-platelet therapy (except low-dose aspirin [e.g., 81 mg daily] for cardioprotection) >li>No known history of human immunodeficiency virus, hepatitis C, or hepatitis B infection
    Patients with Multiple Myeloma must have the following:
  • At least 2 prior regimens, which must include at least 1 approved proteasome inhibitor (e.g., bortezomib, carfilzomib, or ixazomib) and at least 1 approved immunomodulatory agent (e.g., thalidomide, lenalidomide, or pomalidomide), with or without maintenance therapy, unless patients are ineligible to receive such agents
  • Bone marrow biopsy within 28 days of CLR 131 infusion demonstrating at least 5% plasma cell involvement Must have progressive disease and measurable disease
    Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, or Marginal Zone Lymphoma must have the following:
  • Prior treatment with at least 2 prior regimens, which may include chemotherapy, an approved anti-CD20 antibody with or without maintenance therapy, and an approved targeted agent, unless patients are ineligible to receive such agent
  • Patients with Helicobacter pylori+ mucosa-associated lymphoid tissue lymphoma must have received 1 prior antibiotic regimen for H pylori
  • At least 1 measurable nodal lesion with longest diameter > 15 mm or 1 measurable extranodal lesion (e.g., hepatic nodule) with longest diameter > 10 mm
    Patients with Mantle Cell Lymphoma must have the following:
  • Prior treatment with at least 1 prior regimen and at least 1 measurable nodal lesion with longest diameter > 15 mm or 1 measurable extranodal lesion (e.g., hepatic nodule) with longest diameter > 10 mm
    Patients with Diffuse Large B-Cell Lymphoma must have the following:
  • Relapsed or refractory to combination chemotherapy for DLBCL that contains rituximab and an anthracycline. Relapsed disease is defined as either recurrence of disease after a CR or PD after achieving a partial response (PR) or SD. Refractory disease is defined as failure to achieve at least SD with any 1 line of therapy or with
  • PD ≤ 3 months of the most recent chemotherapy regimen
  • At least 1 measurable nodal lesion with longest diameter > 15 mm or 1 measurable extranodal lesion (e.g., hepatic nodule) with longest diameter > 10 mm

  • Applicable Disease Sites Leukemia; Lymphoma; Multiple Myeloma

    Status Open

    Participating Institutions UW Hospital and Clinics