Doxycycline for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02341209|
Recruitment Status : Recruiting
First Posted : January 19, 2015
Last Update Posted : April 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous T-cell Lymphoma Mycosis Fungoides Sezary Syndrome||Drug: Doxycycline monohydrate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||Doxycycline in Patients With Relapsed Cutaneous T-cell Lymphoma|
|Actual Study Start Date :||February 6, 2018|
|Estimated Primary Completion Date :||February 6, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Doxycycline monohydrate
Doxycycline in either capsules or tablets will be administered at 400mg total per day. Patients will be treated for five months, or up to one year for those with a partial response at 5 months.
Drug: Doxycycline monohydrate
Doxycycline will be administered in either tablets or capsules for either five months or a year depending on response.
Other Name: Adoxa, Mondox
- Efficacy of Doxycycline in relapsed CTCL [ Time Frame: From baseline to five month or a year depending on response. ]Overall response rate will be determined after five months or a year from initiation of therapy.
- Duration of Response [ Time Frame: From baseline to up to one year. ]Patients who achieve a Partial Response or Complete Response will be monitored for progression up to one year after initiation of therapy.
- Quality of Life evaluation [ Time Frame: Baseline to up to one year. ]Changes in quality of life will be measured throughout the study using questionnaires.
- Pruritus (Itchiness) evaluation [ Time Frame: Baseline to up to one year. ]Changes in quality of life will be measured throughout the study using questionnaires.
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): NCT02341209
|Contact: Carolina V Alexander-Savino, B.S., CCRCfirstname.lastname@example.org|
|Contact: Brian Poligone, M.D. Ph.D.||585-364-1188|
|United States, New York|
|Rochester General Hospital||Recruiting|
|Rochester, New York, United States, 14621|
|Contact: Carolina V. Alexander-Savino, B.S.,CCRC 585-489-2883 email@example.com|
|Contact: Brian Poligone, M.D. Ph.D. 585-364-1188|
|Principal Investigator:||Brian Poligone, M.D. Ph.D.||Rochester General Hospital|