Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL
Condition: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Acalabrutinib (Arm A); Acalabrutinib (Arm B)
Intervention description: A1a) acalabrutinib, dose A daily: biopsy (T) schedule W;
A1b) acalabrutinib, dose A daily: biopsy (T) schedule V.
A2a) acalabrutinib, dose B q 12 hours: biopsy (T) schedule Y;
A2b) acalabrutinib, dose B q 12 hours; biopsy (T) schedule Z; B1c) acalabrutinib, dose A daily: biopsy (U) schedule W;
• B2c) acalabrutinib, dose B q12 hours: biopsy (U)) schedule Y.
Intervention MeSH terms: Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Healthy volunteers: No
Keywords: Relapsed/refractory CLL; Btk; Leukemia; Lymphocytic; Lymphoma; Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL); ACP-196; Acalabrutinib; Treatment naive CLL; 17p deletion; TP53 mutation; NOTCH1 mutation

Summary:

      This study is to determine the response to acalabrutinib in patients with chronic lymphocytic
      leukemia (CLL) or small lymphocytic lymphoma (SLL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women 18 years of age and older with histologically confirmed disease.

          -  Active disease as defined by at least one of the following (IWCLL consensus criteria):

               -  Weight loss ≥10% within the previous 6 months

               -  Extreme fatigue

               -  Fevers of greater than 100.5ºF for ≥2 weeks without evidence of infection

               -  Night sweats for more than one month without evidence of infection

               -  Evidence of progressive marrow failure as manifested by the development of, or
                  worsening of, anemia and/or thrombocytopenia

               -  Massive or progressive splenomegaly

               -  Massive nodes or clusters or progressive lymphadenopathy

               -  Progressive lymphocytosis with an increase of >50% over a 2 month period, or an
                  anticipated doubling time of less than 6 months

               -  Compensated autoimmune hemolysis

          -  Relapsed/Refractory CLL or treatment naïve CLL patients with 17p deletion, TP53
             mutation, or NOTCH1 mutation

          -  Agreement to use acceptable methods of contraception during the study and for 30 days
             after the last dose of study drug if sexually active and able to bear or beget
             children.

          -  Willing and able to participate in all required evaluations and procedures in this
             study protocol including swallowing capsules without difficulty and serial biopsies.

          -  Ability to understand the purpose and risks of the study and provide signed and dated
             informed consent and authorization to use protected health information (in accordance
             with national and local subject privacy regulations).

        Exclusion Criteria:

          -  Radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or investigational
             products in the last 4 weeks.

          -  Richter's transformation. Autoimmune hemolytic anemia or thrombocytopenia requiring
             steroid therapy. Impaired hepatic function