ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 28 of 538 for:    cutaneous [CONDITION] AND "lymphoma "[CONDITION]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02546440
Recruitment Status : Unknown
Verified May 2016 by Jan Nicolay, Universitätsmedizin Mannheim.
Recruitment status was:  Recruiting
First Posted : September 10, 2015
Last Update Posted : May 11, 2016
Sponsor:
Collaborators:
Klinikum Minden
Klinikum Krefeld
Wuerzburg University Hospital
KKS Netzwerk
Information provided by (Responsible Party):
Jan Nicolay, Universitätsmedizin Mannheim

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.


Condition or disease Intervention/treatment Phase
Cutaneous T Cell Lymphoma Drug: dimethylfumarate Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : September 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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

  2. 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]


Secondary Outcome Measures :
  1. 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]

  2. 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]

  3. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546440


Contacts
Contact: Jan P Nicolay, MD 00496213832280 jan.nicolay@umm.de
Contact: Jochen Utikal, MD 00496213832280 jochen.utikal@umm.de

Locations
Germany
University Medical Center Recruiting
Mannheim, Germany, 68167
Contact: Jan P Nicolay, MD    00496213832280    jan.nicolay@umm.de   
Contact: Jochen Utikal, MD    00496213832280    jochen.utikal@umm.de   
Sponsors and Collaborators
Universitätsmedizin Mannheim
Klinikum Minden
Klinikum Krefeld
Wuerzburg University Hospital
KKS Netzwerk

Responsible Party: Jan Nicolay, MD MSc, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT02546440     History of Changes
Other Study ID Numbers: EudraCT-Number: 2014-000924-11
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs