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Study on Therapy With Dimethylfumarate (DMF) in Patients With Cutaneous T Cell Lymphoma (CTCL) (DMF-CTCL)

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ClinicalTrials.gov Identifier: NCT02546440
Recruitment Status : Recruiting
First Posted : September 10, 2015
Last Update Posted : October 2, 2019
Sponsor:
Collaborators:
Klinikum Minden
Klinikum Krefeld
Wuerzburg University Hospital
KKS Netzwerk
Klinikum Ludwigshafen
Universitätsklinikum Kiel
Information provided by (Responsible Party):
Jan Nicolay, Universitätsmedizin Mannheim

Tracking Information
First Submitted Date  ICMJE September 6, 2015
First Posted Date  ICMJE September 10, 2015
Last Update Posted Date October 2, 2019
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2015)
  • 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]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02546440 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2015)
  • changes in dermatologic life quality index [ Time Frame: every 2 weeks until 24 weeks of treatment are finished ]
    Scores range from 0 [no restriction of life Quality] to 30 [maximal restriction of life Quality]
  • changes in pruritus intensity measured by a visual analog scale [ Time Frame: every 2 weeks until 24 weeks of treatment are finished ]
    Scores range from 0 [no Pruritus] to 10 [worst possible Pruritus]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study on Therapy With Dimethylfumarate (DMF) in Patients With Cutaneous T Cell Lymphoma (CTCL)
Official Title  ICMJE Phase IIA Study on Therapy With the NF-κB Inhibiting and Apoptosis Inducing Drug Dimethylfumarate (DMF) in Patients With Cutaneous T Cell Lymphoma (CTCL)
Brief 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). Secondary endpoints will be CTCL severity index, dermatologic life quality index, itching measured by a VAS and the blood involvement if applicable.

Primary: safety and efficacy of DMF treatment in CTCL Secondary: CTCL severity index, Dermatologic Life Quality index, VAS for itching, blood involvement if appl.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cutaneous T Cell Lymphoma
Intervention  ICMJE Drug: dimethylfumarate
dose escalation from 30 mg/d to 720 mg/d over 9 weeks following a preset design in psoriasis treatment in Germany, oral medication in tablet form. Treatment will last 24 weeks or until unacceptable side effects occur
Study Arms  ICMJE Experimental: treatment arm
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
Intervention: Drug: dimethylfumarate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 9, 2015)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histopathologically confirmed Mycosis fungoides or Sézary syndrome (CTCL stage ≥ Ib according to EORTC-ISCL consensus classification) at study entry with progressive, persistent or recurrent disease
  • Pretreatment with topical steroid and/or local PUVA, if PUVA is not possible anymore or if there is unsatisfactory response to PUVA respectively. Patients with history of first line systemic treatment (interferone or bexarotene) may be included in the study too
  • 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 (differential blood count, liver enzymes, serum creatinine, electrolytes and lipids have to show normal values, no history of restriction of cardiac, kidney or liver function)
  • Negative Pregnancy test from urine, 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 prior to any study specific procedures.

Exclusion Criteria:

  • Another active malignant disease
  • 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
  • Contraindications for treatment with DMF (known hypersensibility to the drug, severe gastrointestinal disease (like ulcerations), Alcohol abuse, other 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jan P Nicolay, MD 00496213832280 jan.nicolay@umm.de
Contact: Jochen Utikal, MD 00496213832280 jochen.utikal@umm.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02546440
Other Study ID Numbers  ICMJE EudraCT-Number: 2014-000924-11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jan Nicolay, Universitätsmedizin Mannheim
Study Sponsor  ICMJE Universitätsmedizin Mannheim
Collaborators  ICMJE
  • Klinikum Minden
  • Klinikum Krefeld
  • Wuerzburg University Hospital
  • KKS Netzwerk
  • Klinikum Ludwigshafen
  • Universitätsklinikum Kiel
Investigators  ICMJE Not Provided
PRS Account Universitätsmedizin Mannheim
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP