A Phase II Study of Doxycycline in Relapsed NHL

Stopped early · Phase 2

Conditions studied: 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

In brief

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

Key facts

Study ID

NCT02086591

Run by

University of Rochester

People needed

7

Starts

2014-03-01

Expected to finish

2015-11-01

Last updated by the study team

2016-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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