A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL
Condition: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Mantle Cell Lymphoma
MeSH terms: Lymphoma; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell
Intervention: TGR-1202; Ibrutinib
Intervention description: Capsules taken whole daily with water and with food; Capsules taken whole with water- Do not consume fish oil, vitamin E, grapefruit, or Seville oranges
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Summary:

      This research study will be evaluating the safety and efficacy of a study drug called
      TGR-1202 in combination with a known drug ibrutinib, also known as Imbruvica, as a possible
      treatment for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Mantle
      Cell Lymphoma (MCL) that has come back or that has not responded to standard treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukemia (CLL),
             or Small Lymphocytic Lymphoma (SLL)

          -  Adequate organ system function ( Absolute neutrophil count, Platelets,Bilirubin,
             Platelets, Aspartate transferase ,Alanine aminotransferase, Creatinine Clearance)

          -  Eastern Cooperative Group (ECOG) Performance status ≤ 2

          -  Ability to swallow and retain oral medication

          -  Female patients: must have negative serum pregnancy test at study screening/ all male
             partners must consent to use a medically acceptable method of contraception

          -  Willingness and ability to comply with trial and follow-up procedures, and give
             written informed consent

        Exclusion Criteria:-

          -  Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy,
             immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization)
             within 3 weeks of Cycle 1/Day 1,

          -  Autologous hematologic stem cell transplant within 3 months of study entry.

          -  Allogeneic hematologic stem cell transplant within 12 months.

               -  Post-allo patients must not have active graft versus-host disease

          -  Evidence of active Hepatitis B,Hepatitis C or HIV infection.

          -  Active central nervous system involvement by lymphoma

          -  Requires treatment with strong CYP3A4/5 inhibitors

          -  Severe and/or uncontrolled medical conditions or other conditions that could affect
             their participation in the study

          -  QTcF >470 msec (QT interval, Fredericia calculation)

          -  Angina not well-controlled by medication

          -  Poorly controlled or clinically significant atherosclerotic vascular disease

          -  Presence of other active cancers, or history of treatment for invasive cancer within
             the past 2 years.

          -  Require warfarin for anticoagulation

          -  Women who are pregnant or lactating