Trial Outcomes & Findings for A Phase II Study of Doxycycline in Relapsed NHL (NCT NCT02086591)

NCT ID: NCT02086591

Last Updated: 2016-12-22

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: Three months
• Results posted on: 2016-12-22

Participant Flow

Participant milestones

Measure	Doxycycline Doxycycline 200 mg twice daily Doxycycline
Overall Study STARTED	7
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Doxycycline Doxycycline 200 mg twice daily Doxycycline
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1
Overall Study protocol terminated	3

Baseline Characteristics

A Phase II Study of Doxycycline in Relapsed NHL

Baseline characteristics by cohort

Measure	Doxycycline n=7 Participants Doxycycline 200 mg twice daily Doxycycline
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Gender Female	2 Participants n=5 Participants
Gender Male	5 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Doxycycline n=7 Participants Doxycycline 200 mg twice daily Doxycycline
Overall Response Rate	28 percentage of participants

SECONDARY outcome

Timeframe: One year

Population: Data was collected on all patients who were enrolled.

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.

Outcome measures

Measure	Doxycycline n=7 Participants Doxycycline 200 mg twice daily Doxycycline
Percentage of Patients With Progression Free Survival	57 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: One year

Population: No data displayed because Outcome Measure has zero total participants analyzed

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.

Outcome measures

Outcome data not reported

Adverse Events

Doxycycline

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Doxycycline n=7 participants at risk Doxycycline 200 mg twice daily Doxycycline
Skin and subcutaneous tissue disorders Photosensitivity	42.9% 3/7
Musculoskeletal and connective tissue disorders musculoskeletal and connective tissue disorder	14.3% 1/7
Investigations alanine aminotransferase increase	14.3% 1/7
Investigations creatinine increased	14.3% 1/7
Infections and infestations sepsis	14.3% 1/7
Gastrointestinal disorders vomiting	28.6% 2/7
Gastrointestinal disorders nausea	85.7% 6/7
General disorders fatigue	28.6% 2/7
General disorders face edema	14.3% 1/7
General disorders pain	14.3% 1/7

Additional Information

Carla Casulo

University of Rochester

Phone: 585-273-3258

Email: carla_casulo@urmc.rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place