A Phase II Study of Doxycycline in Relapsed NHL
Condition: Adult Diffuse Large B-Cell Lymphoma; Mantle Cell Lymphoma Recurrent; Lymphoma, Follicular; Marginal Zone B-Cell Lymphoma; Malignant Lymphoma - Lymphoplasmacytic; Waldenstrom Macroglobulinemia; Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia (CLL); T-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell, Marginal Zone; Waldenstrom Macroglobulinemia; Lymphoma, Follicular
Intervention: Doxycycline
Intervention MeSH terms: Doxycycline
Phase: Phase 2
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
Keywords: Non Hodgkin Lymphoma; Doxycycline

Summary:

      The purpose of this study is to determine whether doxycycline is effective in the treatment
      of relapsed Non Hodgkin Lymphomas (NHL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Relapsed aggressive or indolent NHL following any prior treatment of the following
             etiologies:

               -  Diffuse large B cell lymphoma (DLBCL)

               -  Mantle cell lymphoma (MCL)

               -  Follicular lymphoma (FL)

               -  Marginal zone lymphoma (MZL)

               -  Lymphoplasmacytic lymphoma (LPL)

               -  Waldenstrom's macroglobulinemia (WM)

               -  Small lymphocytic lymphoma (SLL)

               -  Chronic lymphocytic leukemia (CLL)

               -  T cell lymphoma (TCL)

          -  Ages ≥ 18

          -  Karnofsky Performance Status (KPS) ≥ 60% or Eastern Cooperative Oncology Group
             Performance Status (ECOG PS) ≤2

          -  Life expectancy of at least 3 months

          -  Measurable disease in at least one target lesion, assessable by radiographic
             examination with Fludeoxyglucose-Positron Emission Tomography (FDG-PET) or computed
             tomography (CT), bone marrow evaluation showing involvement, or peripheral blood
             showing involvement of lymphoma

          -  Adequate organ function:

               -  Absolute neutrophil count (ANC) > 500 cells/mL and platelet count > 50,000
                  cells/mL unless felt to be secondary to lymphoma at which any count is
                  permissible.

               -  Adequate renal function as determined by Creatinine (Cr) < 1.5x upper limit of
                  normal (ULN) or estimated creatinine clearance of ≥ 60mL/min

               -  Adequate hepatic function as determined by total bilirubin < 1.5x upper limit of
                  normal (ULN) (unless known Gilbert syndrome), alanine aminotransferase (ALT)and
                  aspartate aminotransferase (AST) < 2.5x upper limit of normal (ULN)

        Exclusion Criteria:

          -  Known sensitivity or allergy to tetracyclines

          -  Lack of measurable disease by computed tomography (CT) or Fludeoxyglucose-Positron
             Emission Tomography (FDG-PET)

          -  Karnofsky Performance Status (KPS) <60% or Eastern Cooperative Oncology Group
             Performance Status (ECOG PS) >2

          -  Curative treatment is indicated or possible

          -  Inadequate organ function as measured by not fulfilling above criteria

          -  Pregnancy, positive serum human chorionic gonadotropin (hCG) within 28 days of
             enrollment, or breast-feeding.