LymphomaPhase 3NCT03454945
Efficacy of Doxycycline in the Treatment of Early Stages of Mycosis Fungoides
A Phase 3 study testing Vibramycin and Phototherapy in people with Lymphoma, run by Cairo University at 2 sites in Egypt.
Trial summary
Current study aims at assessing the efficacy of doxycycline as a potential treatment modality for early stages of MF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Vibramycin and Phototherapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Mar 2017to 1 Apr 2019
- Phase
- Phase 3
- 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
- Adults (above 18) of either sex with established diagnosis of classic MF
Who cannot join
- Any variant of MF other than the classic variant.
- Advanced stages of classic MF: Stage IIb, III or IV.
- Pregnant and lactating females.
- Patients with autoimmune diseases e.g. SLE
- Patients with solid or hematological malignancies e.g. breast cancer, leukemia, etc.
- Patients with any contraindications for doxycycline (eg: liver disease, kidney disease, photosensitivity, peptic ulcer or patients receiving systemic retinoids).
- Patients with any contraindication to phototherapy (eg: any other skin cancers or photosensitivity); or to psoralen (eg: liver disease)
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Dermatology departement
Cairo, 11562
Hagar El Sayed, MD, 01051248365, hgr_ntr@yahoo.com
Suzan Shalaby, MD, 01224019459, suzyandnls@gmail.com
- Recruiting
Dermatology department
Cairo, 11562
Hagar El Sayed, Master, 01061248365, hgr_ntr@yahoo.com
Suzan Shalaby, MD, 01224019459, suzyandnls@gmail.com
About this study
Official title: Efficacy of Doxycycline in the Treatment of Early Stages of Mycosis Fungoides: A Randomized Controlled Trial
Current study aims at assessing the efficacy of doxycycline as a potential treatment modality for early stages of MF.
Read the detailed description
Objectives
Objective is to evaluate the efficacy of doxycycline in treatment of early stages of mycosis fungoides (IA, IB and IIA) and to assess its apoptotic enhancing effect by studying the expression of BCL2 by the T lymphocytes.
Study Design
Randomized controlled trial
Population of study \& disease condition
30 patients with early stage mycosis fungoides (Stage Ia,Ib and IIa)
Methodology in details
After signing an informed consent, each participant will be subjected to:
- Baseline evaluation:
- Baseline biopsy to document the current state of the disease and to assess immunohistochemically the expression of CD3 and Bcl2 by the lymphocytes.
- Detailed history taking including onset, course, duration of the disease and history of any previous treatments used.
- Detailed examination of skin lesions and scoring using:
- Modified Severity of Index Weighted Assessment (mSWAT)
- Composite Assessment of Index Lesion Severity (CAILS)
- Pruritus scoring using a visual analog scale from 0-10, where 0=no pruritus and 10=worst imaginable pruritus
- Photography
II. Treatment and dosing protocol:
Participants will be randomly allocated in either one of the treatment groups:
Group A: Will receive oral doxycycline in a dose of 200 mg daily for three months.
Group B: Will receive PUVA with dosing \& increments according to the standard protocols of the Phototherapy Unit, Dermatology Department, Cairo University; 3 sessions per week for 3 months.
III. Timings of follow up visits and clinical assessments done:
Patients will be regularly assessed at weeks 4, 8, and 12. Patients continuing for another three months, as mentioned above, will be assessed at weeks 16, 20 and 24. The following will be done at these follow up visits: mSWAT, CAILS, pruritus scoring and photography. Side effects will be monitored and managed accordingly.
IV. Follow up biopsies:
A repeat biopsy will be taken at initial improvement in CAILS (or at week 12) for immunohistochemical re-assessment of the expression of CD3 and Bcl2 by the lymphocytes.
- Conditions
- Lymphoma
- Being tested
- Vibramycin, Phototherapy
- Keywords
- Mycosis fungoides, Doxycycline
- Medical subject headings
- Lymphoma, Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibramycinDrug
Also called Doxy
Antibiotic
PhototherapyDevice
UVA+Psoralen
| Study group | Role | What they receive |
|---|---|---|
| Doxycyline | Experimental | Oral Vibramycin antibiotic100 mg capsule every 12 hours for 3 months Receives: Drug: Vibramycin; Device: Phototherapy |
| Phototherapy | Active comparator | UVA+ psoralen 3 sessions per week for 3 months Receives: Drug: Vibramycin; Device: Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment
Clinical assessment of the extent of the lesions in body surface area
Measured: 3 months
Secondary outcomes (1)
Pathological assessment
Pathological assessment using immunohistochemistry
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start1 Mar 2017
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar El Sayed, Cairo University
- Investigators
- Mona AbdEl Halim, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454945
- Sponsor's protocol ID
- doxycycline
- Status last verified
- Aug 2018
- First submitted
- 5 Sep 2017
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
PubMed 32632956El Sayed H, Shalaby S, Abdel-Halim MRE, Aboelfadl DM, Samir N. Efficacy of doxycycline in the treatment of early stages of mycosis fungoides: a randomized controlled trial. J Dermatolog Treat. 2021 Jun;32(4):424-431. doi: 10.1080/09546634.2019.1667474. Epub 2019 Sep 20.
PubMed 31526286
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Doxycycline in the Treatment of Early Stages of Mycosis Fungoides: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03454945
- Acronym / sponsor ID
- doxycycline
- Conditions
- Lymphoma
- Keywords
- Mycosis fungoides, Doxycycline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 6 Mar 2018 (actual)
- 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.
Current study aims at assessing the efficacy of doxycycline as a potential treatment modality for early stages of MF.
Detailed description
Objectives
Objective is to evaluate the efficacy of doxycycline in treatment of early stages of mycosis fungoides (IA, IB and IIA) and to assess its apoptotic enhancing effect by studying the expression of BCL2 by the T lymphocytes.
Study Design
Randomized controlled trial
Population of study \& disease condition
30 patients with early stage mycosis fungoides (Stage Ia,Ib and IIa)
Methodology in details
After signing an informed consent, each participant will be subjected to:
- Baseline evaluation:
- Baseline biopsy to document the current state of the disease and to assess immunohistochemically the expression of CD3 and Bcl2 by the lymphocytes.
- Detailed history taking including onset, course, duration of the disease and history of any previous treatments used.
- Detailed examination of skin lesions and scoring using:
- Modified Severity of Index Weighted Assessment (mSWAT)
- Composite Assessment of Index Lesion Severity (CAILS)
- Pruritus scoring using a visual analog scale from 0-10, where 0=no pruritus and 10=worst imaginable pruritus
- Photography
II. Treatment and dosing protocol:
Participants will be randomly allocated in either one of the treatment groups:
Group A: Will receive oral doxycycline in a dose of 200 mg daily for three months.
Group B: Will receive PUVA with dosing \& increments according to the standard protocols of the Phototherapy Unit, Dermatology Department, Cairo University; 3 sessions per week for 3 months.
III. Timings of follow up visits and clinical assessments done:
Patients will be regularly assessed at weeks 4, 8, and 12. Patients continuing for another three months, as mentioned above, will be assessed at weeks 16, 20 and 24. The following will be done at these follow up visits: mSWAT, CAILS, pruritus scoring and photography. Side effects will be monitored and managed accordingly.
IV. Follow up biopsies:
A repeat biopsy will be taken at initial improvement in CAILS (or at week 12) for immunohistochemical re-assessment of the expression of CD3 and Bcl2 by the lymphocytes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycyline | Experimental | Drug: Vibramycin, Device: PhototherapyOral Vibramycin antibiotic100 mg capsule every 12 hours for 3 months |
| Phototherapy | Active comparator | Drug: Vibramycin, Device: PhototherapyUVA+ psoralen 3 sessions per week for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (above 18) of either sex with established diagnosis of classic MF
Key exclusion criteria (7 listed)
- Any variant of MF other than the classic variant.
- Advanced stages of classic MF: Stage IIb, III or IV.
- Pregnant and lactating females.
- Patients with autoimmune diseases e.g. SLE
- Patients with solid or hematological malignancies e.g. breast cancer, leukemia, etc.
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 |
|---|---|---|
| VibramycinAlso: DoxyAntibiotic | Drug | Doxycyline, Phototherapy |
| PhototherapyUVA+Psoralen | Device | Doxycyline, Phototherapy |
Primary outcome
Clinical assessment
Time frame: 3 months
Clinical assessment of the extent of the lesions in body surface area
1 secondary outcome
Pathological assessment
Time frame: 3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Derived from this study: PubMed 32632956Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
- Derived from this study: PubMed 31526286El Sayed H, Shalaby S, Abdel-Halim MRE, Aboelfadl DM, Samir N. Efficacy of doxycycline in the treatment of early stages of mycosis fungoides: a randomized controlled trial. J Dermatolog Treat. 2021 Jun;32(4):424-431. doi: 10.1080/09546634.2019.1667474. Epub 2019 Sep 20.
- Individual participant dataSharing planned: No
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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.
Mona AbdEl Halim, MD principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vibramycin and Phototherapy in people with Lymphoma, run by Cairo University at 2 sites in Egypt.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hagar El Sayed, Master (01061248365, hgr_ntr@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical assessment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03454945, which also lists 2 linked publications.
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 23 Aug 2018.