A Phase II Study of Doxycycline in Relapsed NHL
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|ClinicalTrials.gov Identifier: NCT02086591|
Recruitment Status : Terminated (Lack of accrual)
First Posted : March 13, 2014
Results First Posted : December 22, 2016
Last Update Posted : December 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Doxycycline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Doxycycline in Relapsed NHL|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||November 2015|
Doxycycline 200 mg twice daily
- Overall Response Rate [ Time Frame: Three months ]
Overall response rate is defined as the percentage of patients with disease progression. Progression is defined as:
- Appearance of a new lesion on fluorodeoxyglucose (FDG)-positron emission tomography or computerized tomography
- ≥50% increase in sum of the product of the node dimensions (SPD) of more than one node or in greatest diameter of any previously identified node >1 cm in its short axis from nadir.
- To be considered progressive disease, a lymph node with a diameter of the short axis of less than 1.0 cm must increase by 50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis.
- At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis.
- Percentage of Patients With Progression Free Survival [ Time Frame: One year ]Progression free survival is defined as the percentage of patients with stable disease or no death. Stable disease is defined as less than a partial response but is not progressive disease. Partial Response (PR)-At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses as determined byFDG-PET for CT scan. No increase should be observed in the size of other nodes, liver, or spleen. Patients who achieve a CR by the above criteria, but who have persistent morphologic bone marrow involvement will be considered partial responders. When the bone marrow was involved before therapy and a clinical CR was achieved, but with no bone marrow assessment after treatment, patients should be considered partial responders.
- Exploratory Objective [ Time Frame: One year ]To investigate change in plasma matrix metalloproteinase 9 (MMP9) levels as a biomarker of treatment response; to assess plasma matrix metalloproteinase 9 (MMP9) expression by immunohistochemistry (IHC) and correlate to response in order to test the hypothesis that elevated intratumoral levels of plasma matrix metalloproteinase 9 (MMP9) can predict response to doxycycline. To assess activation/expression of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kb) and Signal transducer and activator of transcription 3 (STAT 3) pathways in archived tumor by immunohistochemistry (IHC) to predict response or resistance to doxycycline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086591
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Carla Casulo, MD||University of Rochester|