Study of MK-8808 for Participants With Follicular Lymphoma (MK-8808-001)
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: MK-8808; cyclophosphamide; vincristine; prednisolone
Intervention MeSH terms: Prednisolone; Cyclophosphamide; Vincristine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, pharmacokinetics, and anti-tumor activity of MK-8808 in
      combination with cyclophosphamide, vincristine, and prednisolone (CVP), and as a single
      agent, for participants with B-lymphocyte antigen cluster of differentiation 20
      (CD20)-positive follicular lymphoma who have had no prior chemotherapy. The primary study
      hypothesis is that MK-8808 will be safe and well tolerated in combination with CVP and as a
      single agent.
    

Eligibility criteria:

        Inclusion criteria:

          -  Histological diagnosis of CD20-positive follicular lymphoma, Grade 1, 2, or 3a (World
             Health Organization [WHO] 2008 classification) based on an excisional or incisional
             lymph node biopsy or a bone marrow biopsy.

          -  Ann Arbor Stage III or IV disease.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.

          -  Life expectancy >3 months with no expected need of immediate intervention to treat
             life-threatening complications.

          -  Adequate organ function.

          -  Participants must agree to use an adequate method of contraception starting with the
             first dose of study drug through 12 months (for females) or 90 days (for males) after
             the last dose of study drug.

        Exclusion criteria:

          -  Histological Grade 3b or with >50% diffuse architectural pattern.

          -  Circulating malignant cells >25,000/mm^3

          -  Presence or history of central nervous system (CNS) disease (either CNS lymphoma or
             lymphomatous meningitis).

          -  Prior treatment with chemotherapy, rituximab, any other anti-CD20 compound, or any
             other type of anti-cancer compounds.

          -  Radiotherapy within 2 months prior to Cycle 1 Day 1.

          -  Current participation or has participated in a study with an investigational compound
             within 30 days prior to Cycle 1 Day 1.

          -  Concomitant disease that requires continuous therapy with prednisone at doses >20 mg
             per day.

          -  Any medical contraindication for prednisolone as being dosed in the CVP regimen.

          -  Poorly controlled diabetes mellitus, as defined by institutional or local standards.

          -  Grade >2 peripheral neuropathy.

          -  Has one of the following:

               1. is human immunodeficiency virus (HIV)-positive

               2. is Hepatitis B surface antigen positive (HBsAg+) or is positive for antibodies to
                  Hepatitis B core antigen (anti-HBcAg+)

               3. has antibodies to Hepatitis C virus

          -  Has one or more of the following:

               1. Active tuberculosis based on institutional diagnostic criteria and local practice
                  guidelines.

               2. Evidence of a tuberculosis infection based on a chest X-ray (CXR) or computed
                  tomography (CT) scan performed within 3 months of dosing.

               3. History of a tuberculosis infection.

          -  Major surgical procedure within 4 weeks prior to Cycle 1 Day 1.

          -  Regular use (including "recreational" use) of any illicit drugs or recent history
             (within the last year) of drug or alcohol abuse or dependence.

          -  Pregnant or breastfeeding.