A Phase II Study of Doxycycline in Relapsed NHL

• Status: Terminated
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Doxycycline

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.