Trial document





This trial has been registered retrospectively.
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  DRKS00003693

Trial Description

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Title

ADO CTCL-3 (Tarado): Multicentric therapy protocol for bexarotene (Targretin ®) monotherapy in pretreated CTCL stage ≥Ib with clear assignment to a EORTC-Diagnosis

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Trial Acronym

Tarado

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Therapy protocol for bexarotene (Targretin ®) monotherapy in treatment-stage CTCL

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Brief Summary in Scientific Language

Histopathologically documented CTCL stage Ib and ≥ EORTC classification for staging

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Organizational Data

  •   DRKS00003693
  •   2012/12/05
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  •   yes
  •   Approved
  •   07/2004, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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Health Condition or Problem studied

  •   TCELLLYMPHOMA
  •   C84 -  Peripheral and cutaneous T-cell lymphomas
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Interventions/Observational Groups

  •   150-300mg / m bexarotene daily per os for at least 24 weeks
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   No
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Primary Outcome

Effectiveness of bexarotene monotherapy in various defined CTCL subtypes

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Secondary Outcome

n/a

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Countries of Recruitment

  •   Germany
  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2004/07/01
  •   200
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Histopathologically documented CTCL stage ≥ Ib and grading by EORTC (Appendix K)
Staging, EORTC classification
2. Pretreatment with PUVA if a continuation of the PUVA is no longer possible or with inadequate response
3. Karnofsky performance status> 60%
4. Age ≥ 18 years
5. Adequate organ function (blood count, liver, kidney, cardiac function, electrolytes, lipids)
6. Neg. Pregnancy test, efficient contraception in male and female patients (bexarotene could lead to decreased efficacy of hormonal contraceptives)
7. No other active malignancy
8. No topical chemotherapy, photopheresis or interferon treatment to 28 days prior to study entry
9. No topical treatment (steroids, tar-bath), superficial radiotherapy, treatment with other retinoids or beta-carotene two weeks ago baseline *
10. No serious systemic disease or infection at study entry
11. No participation in another study in the last 14 days prior to study entry
12. No pre-treatment with Targretin
13. Lack of psychological, familial, sociological or geographical obstacles that hinder the study protocol or the follow-up control
14. No contraindications to treatment with bexarotene (known hypersensitivity to retinoids, hypervitaminosis A, status after pancreatitis, alcohol abuse, drugs that can be toxic to the pancreas or increase lipid levels, uncontrolled diabetes mellitus, uncontrolled (thyroid disorder)
15. A signed consent of the patient
*Continuous topical steroid applications before and during treatment withTargretin

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Exclusion Criteria

1. Mucosal or ocular melanoma melanoma
2. Intransitmetastasen
3. Other adjuvant therapy (systemic therapy with an immunomodulator of a previous operation is allowed, provided that the last dose at least 30 days earlier; prior radiotherapy before lymphadenectomy is allowed)
4. Autoimmune disorders (vitiligo außgenommen)
5. Immunodeficiency
6. Other malignancies (excluding carcinoma in situ of the cervix or remission over 5 years)
7. Uncontrolled bleeding

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Schleswig-Holstein Campus Kiel
    • Mr.  Prof. Dr. med.  Michael  Weichenthal 
    • Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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    • Klinik für Dermatologie, Venerologie und Allergologie Christian-Albrechts-Universität zu Kiel
    • Mr.  Prof. Dr. med.  Michael  Weichenthal 
    • Schittenhelmstr.7
    • D-24105  Kiel
    • Germany
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    • Klinik für Dermatologie, Venerologie und Allergologie Christian-Albrechts-Universität zu Kiel
    • Mr.  Prof. Dr. med.  Michael  Weichenthal 
    • Schittenhelmstr.7
    • D-24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Universitäts-Klinikum Schleswig-Holstein, Campus Kiel
    • 24105  Kiel
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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