Study of LY2835219 for Mantle Cell Lymphoma
Condition: Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: Abemaciclib
Intervention description: Administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non- Hodgkins Lymphoma

Summary:

      The purpose of this study is to estimate the disease control rate with abemaciclib for
      relapsed or refractory mantle cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of relapsed or refractory Mantle Cell Lymphoma (MCL) according to the
             World Health Organization (WHO) classification that has relapsed after, or been
             refractory to, available standard treatments. However, participants who are intolerant
             of, or unable to receive a standard treatment are not required to have MCL that has
             relapsed after, or been refractory to, that specific standard treatment. Pathology
             must be reviewed and confirmed at the investigational site where participant is
             entered prior to enrollment

          -  Have disease that is assessable according to the Response Criteria for Non- Hodgkin's
             Lymphomas

          -  Have given written informed consent prior to any study-specific procedures

          -  Have adequate organ function including:

               -  Hematologic: Absolute neutrophil count (ANC) ≥1.5 x 10^9/Liter (L), platelets ≥75
                  x 10^9/L, and hemoglobin ≥8 grams per deciliter (g/dL)

               -  Hepatic: Bilirubin ≤1.5 times upper limits of normal (ULN) and alanine
                  aminotransferase (ALT) ≤3.0 times ULN

               -  Renal: Estimated creatinine clearance ≥50 milliliter per minute (ml/min)

          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or
             2

          -  Have discontinued all previous therapies for cancer (including chemotherapy,
             radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for
             myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving
             study drug, and recovered from the acute effects of therapy (treatment-related
             toxicity resolved to baseline) except for residual alopecia

          -  Are willing to make themselves available for the duration of the study and to follow
             study procedures

          -  Are amenable to compliance with protocol schedules and testing

          -  Males and females with reproductive potential must agree to use medically approved
             contraceptive precautions during the trial and for 3 months following the last dose of
             study drug

          -  Females with child-bearing potential must have a negative serum pregnancy test within
             14 days of the first dose of study drug

          -  Have a life expectancy of ≥12 weeks

          -  Are able to swallow capsules

        Exclusion Criteria:

          -  Are currently enrolled in, or discontinued within 14 or 21 days of the initial dose of
             study drug for a nonmyelosuppressive or myelosuppressive agent, respectively, a
             clinical trial involving an investigational product or non-approved use of a drug or
             device other than the study drug used in this study, or concurrently enrolled in any
             other type of medical research judged not to be scientifically or medically compatible
             with this study

          -  Have serious preexisting medical conditions that, in the judgment of the investigator,
             would preclude participation in this study (for example, pneumonia, inflammatory bowel
             disease, history of major surgical resection involving the stomach or small bowel)

          -  Have symptomatic metastasis to the central nervous system (CNS). Participants may have
             CNS metastasis that is radiographically or clinically stable for at least 14 days
             prior to receiving study drug, regardless of whether they are receiving
             corticosteroids

          -  Have received an autologous or allogeneic stem-cell transplant within 75 days of the
             initial dose of study drug. In addition, recipients of an allogenic stemcell
             transplant must have discontinued immunosuppressive therapy at least 14 days before
             study drug administration with no more than Grade 1 acute graft versus-host disease on
             Day 1 of Cycle 1

          -  Females who are pregnant or lactating

          -  Have active bacterial, fungal, and/or known viral infection (for example, human
             immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen [HBSAg], or
             hepatitis C antibodies). Screening is not required for enrollment

          -  Have a baseline electrocardiogram (ECG) with any of the following findings:
             ventricular tachycardia, ventricular fibrillation, abnormal QTcB (defined as ≥450
             milliseconds for males and ≥470 milliseconds for females), or evidence of acute
             myocardial ischemia