Cutaneous T-cell LymphomaPhase 2CTCLNCT02341209
Doxycycline for the Treatment of Cutaneous T-Cell Lymphoma
A Phase 2 study testing Doxycycline monohydrate in people with Cutaneous T-cell Lymphoma and Mycosis Fungoides, run by Rochester General Hospital at 1 site in United States.
Trial summary
This study looks at the efficacy of Doxycycline for the treatment of Cutaneous T-cell Lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T-cell Lymphoma, Mycosis Fungoides, Sezary Syndrome
- What is being tested?
- Doxycycline monohydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2018to 6 Feb 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signed and dated Institutional Review Board approved informed consent form in accordance with regulatory and institutional guidelines. Written informed consent must be obtained prior to performing any study-related procedure.
- Be 18 years of age or older at time of enrollment.
- Measurable disease in at least one target lesion in the skin or able to be assessed by radiographic examination with FDG-PET fluorodeoxyglucose possitron emission tomography (FDG-PET) scan or computarized tomography (CT) scan, or peripheral blood showing involvement of lymphoma.
- The subject has resolution of all clinically significant toxic effects of prior cancer therapy to Grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v.4.0) excluding the specification below.
- 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.
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- Adequate renal function as determined by creatinine < 1.5x upper limit normal (ULN) or estimated creatinine clearance of ≥ 60ml/min
- Adequate hepatic function as determined by total bilirubin < 1.5x ULN (unless known Gilbert syndrome), Alanine transaminase (ALT) and Aspartate transaminase (AST) < 2.5x ULN
- Confirmed diagnosis of CTCL.
- Karnofsky Performance Status ≥ 60%
- Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days of receiving study medication and monthly while on receiving doxycycline
- WOCBP must agree to use effective contraception, defined as, oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide) or practice true abstinence from sexual intercourse (periodic abstinence, e.g., calendar ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception) during the study and for 3 months after the last dose. WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea ≥ 12 consecutive months without an alternative medical cause).
- Male subjects and their female partners of child bearing potential must be willing to use an appropriate method of contraception defined as, oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide) or practice true abstinence from sexual intercourse (periodic abstinence, e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception) during the study and for 3 months after the last dose.
Who cannot join
- Known sensitivity or allergy to tetracyclines
- Lack of measurable disease
- Karnofsky Performance Status <60%
- Inadequate organ function as measured by not fulfilling above criteria
- Subject is pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rochester General Hospital
Rochester, New York, 14621
About this study
Official title: Doxycycline in Patients With Relapsed Cutaneous T-cell Lymphoma
This study looks at the efficacy of Doxycycline for the treatment of Cutaneous T-cell Lymphomas.
Read the detailed description
The aim of this study is to evaluate the efficacy of doxycycline in relapsed Cutaneous T-cell Lymphomas (CTCL). The primary objective is to determine the overall response rate of doxycycline monotherapy in patients with relapsed CTCL.
- Being tested
- Doxycycline monohydrate
- Keywords
- CTCL, Sezary Syndrome (SS), Mycosis Fungoides (MF), Cutaneous T-cell Lymphoma, MF, SS
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxycycline monohydrateDrug
Also called Adoxa, Mondox
Doxycycline will be administered in either tablets or capsules for either five months or a year depending on response.
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline monohydrate | Experimental | 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. Receives: Drug: Doxycycline monohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Doxycycline in relapsed CTCL
Overall response rate will be determined after five months or a year from initiation of therapy.
Measured: From baseline to five month or a year depending on response.
Secondary outcomes (1)
Duration of Response
Patients who achieve a Partial Response or Complete Response will be monitored for progression up to one year after initiation of therapy.
Measured: From baseline to up to one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study start6 Feb 2018
- Primary completion6 Feb 2021
- Study completion6 Feb 2021
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rochester General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Poligone, MD, PhD, Rochester General Hospital
- Investigators
- Brian Poligone, M.D. Ph.D., Principal investigator, Rochester General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341209
- Sponsor's protocol ID
- 53677
- Acronym
- CTCL
- Status last verified
- Apr 2021
- First submitted
- 21 Nov 2014
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: As required
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doxycycline in Patients With Relapsed Cutaneous T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT02341209
- Acronym / sponsor ID
- CTCL / 53677
- Keywords
- CTCL, Sezary Syndrome (SS), Mycosis Fungoides (MF), Cutaneous T-cell Lymphoma, MF, SS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Rochester General HospitalUniversity, hospital or other
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 6 Feb 2021 (actual)
- Study completion
- 6 Feb 2021 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study looks at the efficacy of Doxycycline for the treatment of Cutaneous T-cell Lymphomas.
Detailed description
The aim of this study is to evaluate the efficacy of doxycycline in relapsed Cutaneous T-cell Lymphomas (CTCL). The primary objective is to determine the overall response rate of doxycycline monotherapy in patients with relapsed CTCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doxycycline monohydrate | Experimental | Drug: Doxycycline monohydrateDoxycycline 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntarily signed and dated Institutional Review Board approved informed consent form in accordance with regulatory and institutional guidelines. Written informed consent must be obtained prior to performing any study-related procedure.
- Be 18 years of age or older at time of enrollment.
- Measurable disease in at least one target lesion in the skin or able to be assessed by radiographic examination with FDG-PET fluorodeoxyglucose possitron emission tomography (FDG-PET) scan or computarized tomography (CT) scan, or peripheral blood showing involvement of lymphoma.
- The subject has resolution of all clinically significant toxic effects of prior cancer therapy to Grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v.4.0) excluding the specification below.
- Adequate organ function:
Key exclusion criteria (5 listed)
- Known sensitivity or allergy to tetracyclines
- Lack of measurable disease
- Karnofsky Performance Status <60%
- Inadequate organ function as measured by not fulfilling above criteria
- Subject is pregnant or breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxycycline monohydrateAlso: Adoxa, MondoxDoxycycline will be administered in either tablets or capsules for either five months or a year depending on response. | Drug | Doxycycline monohydrate |
Primary outcome
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.
1 secondary outcome
Duration of Response
Time frame: From baseline to up to one year.
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: Yes. As required
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Poligone, M.D. Ph.D. principal investigator
Rochester General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxycycline monohydrate in people with Cutaneous T-cell Lymphoma and Mycosis Fungoides, run by Rochester General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Doxycycline in relapsed CTCL (time frame: From baseline to five month or a year depending on response.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.