Cutaneous T Cell LymphomaPhase 2DMF-CTCLNCT02546440
Study on Therapy With Dimethylfumarate (DMF) in Patients With Cutaneous T Cell Lymphoma (CTCL)
A Phase 2 study testing Dimethyl fumarate in people with Cutaneous T Cell Lymphoma, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
The main objective of the trial is to investigate whether oral treatment of patients suffering from cutaneous T cell lymphoma with dimethylfumarate is leading to a significant improvement of modified severity assessment tool (mSWAT) values in the skin after 24 weeks of treatment (primary endpoint). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T Cell Lymphoma
- What is being tested?
- Dimethyl fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to Sep 2022
- 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
- Histopathologically confirmed Mycosis fungoides or Sézary syndrome (CTCL stage ≥ Ib according to EORTC-ISCL consensus classification) at study entry with progressive, persistant or recurrent disease
- Pretreatment with at least one topical or systemic CTCL therapy or UV therapy, if the prior therapy is not possible anymore or if there is new contraindication or unsatisfactory response
- Karnofsky index ≥70 % (according to Karnofsky DA, Burchenal JH. (1949). "The Clinical Evaluation of Chemotherapeutic Agents in Cancer." In: MacLeod CM (Ed), Evaluation of Chemotherapeutic Agents. Columbia Univ Press. Page 196)
- Life expectancy > 3 months
- Age ≥ 18 years
- Adequate organ function:
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- differential blood count: hemoglobin ≥ 10 g/dl without transfusions, leukocyte count > 3000/µl, lymphocyte count > 700/µl
- liver enzymes ≤ 2 x upper limit of normal (ULN)
- serum creatinine ≤ 1.5 mg/dl or calculate creatinine clearance ≥ 50 ml/min,
- Negative Pregnancy test from blood, agreement for efficient contraception in male and female patients unless infertility is documented (DMF is not approved during pregnancy)
- Ability to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study
- written informed consent must be given according to ICH/GCP, and national/local regulations, before patient registration and prior to any study specific procedures.
Who cannot join
- Another active malignant disease with the following exceptions:
- Basal or squamous cell carcinoma of the skin
- In situ carcinoma of the cervix or the skin
- Topical chemotherapy, superficial radiotherapy, photopheresis or systemic CTCL treatment within 28 days before study therapy initiation
- Severe systemic disease or infection at study therapy initiation
- Prior treatment with DMF or simultaneous topical DMF treatment
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- Contraindications for treatment with DMF (known hypersensibility to the drug, severe gastrointestinal disease (like ulcerations), Alcohol abuse, other obligately liver- or nephrotoxic medication, known clinically apparent renal or hepatic insufficiency)
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Participation in other clinical studies within 14 days before study therapy initiation
- Pregnant or lactating patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IIA Study on Therapy With the NF-κB Inhibiting and Apoptosis Inducing Drug Dimethylfumarate (DMF) in Patients With Cutaneous T Cell Lymphoma (CTCL)
The main objective of the trial is to investigate whether oral treatment of patients suffering from cutaneous T cell lymphoma with dimethylfumarate is leading to a significant improvement of modified severity assessment tool (mSWAT) values in the skin after 24 weeks of treatment (primary endpoint). Secondary endpoints are dermatologic life quality index, itching and pain measured by a NRS and the blood involvement if applicable.
Primary: safety and efficacy of DMF treatment in CTCL Secondary: Dermatologic Life Quality index, NRS for itching and pain, blood involvement if appl.
- Conditions
- Cutaneous T Cell Lymphoma
- Being tested
- Dimethyl fumarate
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dimethyl fumarateDrug
dose escalation from 30 mg/d to maximally 720 mg/d over 9 weeks, then continuing with the highest tolerated dose following a preset design in psoriasis treatment in Germany, oral medication in tablet form. Treatment will last 24 weeks or until either progression or unacceptable side effects occur
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | patients are treated with dimethylfumarate over 24 weeks. Dosage will be escalated weekly from 30 mg/d to 720 mg/d over 9 weeks. The dose escalation scheme is the same as approved for psoriasis treatment in Germany Receives: Drug: Dimethyl fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety (via occurrence of AE/SAE) of DMF treatment in CTCL
Number of patients with Treatment-related Adverse Events as assessed by CTCAE v4.0
Measured: every 2 weeks until 24 weeks of treatment are finished
efficacy (via improvement of Skin involvement measured by the standardized modified severity weighted assessment tool (mSWAT))of DMF treatment in CTCL
Changes in the mSWAT scores range from 0 [no patches, Plaques or tumors on the Skin ] to 400 [complete Body covered by Tumors]
Measured: every 2 weeks until 24 weeks of treatment are finished
Secondary outcomes (3)
changes in dermatologic life quality index
Scores range from 0 [no restriction of life Quality] to 30 [maximal restriction of life Quality]
Measured: every 2 weeks until 24 weeks of treatment are finished
changes in pruritus intensity measured by a visual analog scale
Scores range from 0 [no Pruritus] to 10 [worst possible Pruritus]
Measured: every 2 weeks until 24 weeks of treatment are finished
changes in blood involvement measured by Sezary cell count (if applicable, only in stage IV patients)
Measured: every 2 weeks until 24 weeks of treatment are finished
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2021
- Study completionSep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Minden, Helios Klinikum Krefeld, Wuerzburg University Hospital, KKS Netzwerk, Klinikum Ludwigshafen, University of Kiel
- Responsible party
- Principal investigator, Jan Nicolay, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546440
- Sponsor's protocol ID
- EudraCT-Number: 2014-000924-11
- Acronym
- DMF-CTCL
- Status last verified
- Mar 2023
- First submitted
- 6 Sep 2015
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nicolay JP, Melchers S, Albrecht JD, Assaf C, Dippel E, Stadler R, Wehkamp U, Wobser M, Zhao J, Burghaus I, Schneider S, Gulow K, Goerdt S, Schurch CM, Utikal JS, Krammer PH. Dimethyl fumarate treatment in relapsed and refractory cutaneous T-cell lymphoma: a multicenter phase 2 study. Blood. 2023 Aug 31;142(9):794-805. doi: 10.1182/blood.2022018669.
PubMed 37217183
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIA Study on Therapy With the NF-κB Inhibiting and Apoptosis Inducing Drug Dimethylfumarate (DMF) in Patients With Cutaneous T Cell Lymphoma (CTCL)
- ClinicalTrials.gov ID
- NCT02546440
- Acronym / sponsor ID
- DMF-CTCL / EudraCT-Number: 2014-000924-11
- Conditions
- Cutaneous T Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Collaborators
- Klinikum Minden, Helios Klinikum Krefeld, Wuerzburg University Hospital, KKS Netzwerk, Klinikum Ludwigshafen, University of Kiel
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2021 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 10 Sep 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.
The main objective of the trial is to investigate whether oral treatment of patients suffering from cutaneous T cell lymphoma with dimethylfumarate is leading to a significant improvement of modified severity assessment tool (mSWAT) values in the skin after 24 weeks of treatment (primary endpoint). Secondary endpoints are dermatologic life quality index, itching and pain measured by a NRS and the blood involvement if applicable.
Primary: safety and efficacy of DMF treatment in CTCL Secondary: Dermatologic Life Quality index, NRS for itching and pain, blood involvement if appl.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: Dimethyl fumaratepatients are treated with dimethylfumarate over 24 weeks. Dosage will be escalated weekly from 30 mg/d to 720 mg/d over 9 weeks. The dose escalation scheme is the same as approved for psoriasis treatment in Germany |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histopathologically confirmed Mycosis fungoides or Sézary syndrome (CTCL stage ≥ Ib according to EORTC-ISCL consensus classification) at study entry with progressive, persistant or recurrent disease
- Pretreatment with at least one topical or systemic CTCL therapy or UV therapy, if the prior therapy is not possible anymore or if there is new contraindication or unsatisfactory response
- Karnofsky index ≥70 % (according to Karnofsky DA, Burchenal JH. (1949). "The Clinical Evaluation of Chemotherapeutic Agents in Cancer." In: MacLeod CM (Ed), Evaluation of Chemotherapeutic Agents. Columbia Univ Press. Page 196)
- Life expectancy > 3 months
- Age ≥ 18 years
Key exclusion criteria (10 listed)
- Another active malignant disease with the following exceptions:
- Basal or squamous cell carcinoma of the skin
- In situ carcinoma of the cervix or the skin
- Topical chemotherapy, superficial radiotherapy, photopheresis or systemic CTCL treatment within 28 days before study therapy initiation
- Severe systemic disease or infection at study therapy initiation
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 |
|---|---|---|
| Dimethyl fumaratedose escalation from 30 mg/d to maximally 720 mg/d over 9 weeks, then continuing with the highest tolerated dose following a preset design in psoriasis treatment in Germany, oral medication in tablet form. Treatment will last 24 weeks or until either progression or unacceptable side effects occur | Drug | treatment arm |
Primary outcome
safety (via occurrence of AE/SAE) of DMF treatment in CTCL
Time frame: every 2 weeks until 24 weeks of treatment are finished
Number of patients with Treatment-related Adverse Events as assessed by CTCAE v4.0
efficacy (via improvement of Skin involvement measured by the standardized modified severity weighted assessment tool (mSWAT))of DMF treatment in CTCL
Time frame: every 2 weeks until 24 weeks of treatment are finished
Changes in the mSWAT scores range from 0 [no patches, Plaques or tumors on the Skin ] to 400 [complete Body covered by Tumors]
3 secondary outcomes
changes in dermatologic life quality index
Time frame: every 2 weeks until 24 weeks of treatment are finished
changes in pruritus intensity measured by a visual analog scale
Time frame: every 2 weeks until 24 weeks of treatment are finished
changes in blood involvement measured by Sezary cell count (if applicable, only in stage IV patients)
Time frame: every 2 weeks until 24 weeks of treatment are finished
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Derived from this study: PubMed 37217183Nicolay JP, Melchers S, Albrecht JD, Assaf C, Dippel E, Stadler R, Wehkamp U, Wobser M, Zhao J, Burghaus I, Schneider S, Gulow K, Goerdt S, Schurch CM, Utikal JS, Krammer PH. Dimethyl fumarate treatment in relapsed and refractory cutaneous T-cell lymphoma: a multicenter phase 2 study. Blood. 2023 Aug 31;142(9):794-805. doi: 10.1182/blood.2022018669.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dimethyl fumarate in people with Cutaneous T Cell Lymphoma, run by Universitätsmedizin Mannheim at 1 site in Germany.
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 12 inclusion and 10 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: finished, as of the sponsor's last update on 31 Mar 2023. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
safety (via occurrence of AE/SAE) of DMF treatment in CTCL (time frame: every 2 weeks until 24 weeks of treatment are finished). The study lists 2 primary outcomes in all. 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 NCT02546440, which also lists 1 linked publication.
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 31 Mar 2023.