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    Summary
    EudraCT Number:2019-004891-20
    Sponsor's Protocol Code Number:1754-CLTF
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-12-03
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2019-004891-20
    A.3Full title of the trial
    Study to determine the aetiology of chlormethine gel induced-skin drug reaction in early stage mycosis fungoides cutaneous T cell lymphoma (MF-CTCL)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Rash aEtiology After CHlormethine gel
    A.3.2Name or abbreviated title of the trial where available
    REACH
    A.4.1Sponsor's protocol code number1754-CLTF
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04218825
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEuropean Organisation for Research and Treatment of Cancer
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEuropean Organisation for Research and Treatment of cancer
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportHELSINN HEALTHCARE SA
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportRECORDATI RARE DISEASES Sarl
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuropean Organisation for Research and Treatment of Cancer
    B.5.2Functional name of contact pointRegulatory Affairs Department
    B.5.3 Address:
    B.5.3.1Street Address83/11 Avenue E. Mounnier
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number003227741311
    B.5.5Fax number003227727063
    B.5.6E-mailregulatory@eortc.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name LEDAGA
    D.2.1.1.2Name of the Marketing Authorisation holderHELSINN Healthcare SA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/12/963
    D.3 Description of the IMP
    D.3.1Product nameLEDAGA
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNChlormethine
    D.3.9.1CAS number 55-86-7
    D.3.9.2Current sponsor codeChlormethine
    D.3.9.3Other descriptive nameCHLORMETHINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB01220MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.16
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Early stage mycosis fungoides cutaneous T cell lymphoma (MF-CTCL)
    E.1.1.1Medical condition in easily understood language
    Cutaneous lymphoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10028483
    E.1.2Term Mycosis fungoides
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the trial is to determine activity of the drug as measured by response rate in patients treated with chlormethine gel (CL gel) without skin drug reaction (Group A) and in patients treated with CL gel with skin drug reactions and subsequent reduced CL gel application frequency (Group B).
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    • To determine activity of the drug as measured by response rate in patients treated with CL gel (overall population)
    • To determine the number of patients developing a skin reaction to CL gel and the percentage who are subsequently patch test positive
    • To determine the percentage of patients with skin drug reactions remaining on CL gel whether at reduced frequency, or co-administration of corticosteroids (Group B and C)
    • To determine time to occurrence of skin drug reaction, time to response, and duration of response
    • To determine Progression free survival (PFS)
    • To determine Time to Next Treatment (TTNT)
    Exploratory objectives:
    • To determine activity of the drug as measured by response rate in patients treated with CL gel with skin drug reactions, with subsequent reduced CL gel application and administration of topical corticosteroids (Group C)
    • To determine quality of life
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnosis of MF-CTCL stage IA or IB at enrolment as per ISCL/EORTC revision to the MF and Sézary syndrome classification [3] and MF stage should have never met the criteria for stage IIA or higher in the patient medical history
    •Availability of tumour biopsy for histological diagnosis of MF-CTCL not older than 12 months. Patients may have had MF for several years.
    • Age ≥ 18
    • ECOG/WHO performance status 0-2
    • Lesions cover less than 80% of BSA
    • Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior enrolment
    • WOCBP should use adequate birth control measures, during the study treatment period until 30 days after treatment. (See Appendix H). Male subjects who are partner of WOCBP should use condom during treatment.
    • Female subjects who are breast feeding should discontinue nursing prior to the first application of study treatment and until 30 days after the last study treatment
    • Before patient enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations
    E.4Principal exclusion criteria
    • Known hypersensitivity to any component of the Chlormethine gel formulation
    • Previous treatment with CL gel
    • Concurrent or planned local or systemic anti-CTCL therapy
    • Prior treatment with antihistamines or narrow band UV-B or PUVA therapy one week before enrolment, or systemic corticosteroids or radiotherapy in the last 4 weeks before enrolment
    • Prior treatment with topical steroids in the patch test area (upper back) one week before enrolment
    • MF or other pathological skin lesions in the patch test area (upper back)
    • Acute flare of atopic dermatitis or other dermatosis in the last 3 weeks
    • Current or recent (past 6 months) history of severe or uncontrolled renal, hepatic, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
    A severe disease is defined as a condition which is medically significant although not immediately life-threatening, requires urgent medical intervention, hospitalization or prolongation of hospitalization, is disabling and/or limiting self-care (bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden). All diseases classified as grade 3 or above according to CTCAE version 5.0 are severe conditions.
    • Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, according to the investigator's opinion.
    • 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 enrolment in the trial
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study is Overall response rate (ORR) defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) within the first 56 weeks from start of treatment in in patients treated with chlormethine gel (CL gel) without skin drug reaction (Group A) and in patients treated with CL gel with skin drug reactions and subsequent reduced CL gel application frequency (Group B). The response needs to be longer than 8 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    ORR in Group A and in Group B is defined within a time frame for the response evaluation up to maximum 56 weeks starting from first use of the gel. The response should be confirmed within 8 weeks of the first date of response.
    E.5.2Secondary end point(s)
    • Proportion of ORR in the overall population within the first 56 weeks from the start of the treatment
    • Proportion of patients with skin drug reactions remaining on CL gel whether at reduced frequency, or co-administration of corticosteroids. This endpoint is applicable to Group B and C
    • Frequency of occurrence of skin drug reaction
    •Time to occurrence of skin drug reaction
    • Time to response.
    • Duration of response.
    • Progression free survival (PFS)
    • Time to Next Treatment (TTNT)
    E.5.2.1Timepoint(s) of evaluation of this end point
    -ORR in the overall population defined within a time frame for response evaluation up to 56 wks starting from 1st gel use
    -Prop. of patients remaining on treatment (ttmt) in grp B & C defined within 56 wks from ttmt start
    -Freq. of occurrence of skin drug reaction defined within the first 56 wks from ttmt start
    -Time to occurrence of skin drug reaction, defined as time from ttmt start until time of occurrence of a skin drug reaction
    -Time to response defined from ttmt start to first occurrence of complete/partial response
    -Duration of response defined from first occurrence of complete/partial response to ttmt until disease progression
    -PFS defined from start of ttmt to disease progression or death from any cause
    -TTNT defined from start of ttmt until next one for mycosis fungoides
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    • Biobanking
    • Quality of Life (QoL)
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of trial occurs on the date of the last visit of the last patient undergoing the trial.
    End of study (when the trial database can be frozen for the primary data analysis) occurs when the following criteria have been satisfied:
    1.Thirty days after all patients have stopped protocol treatment or reached the 56-week timepoint
    2.The trial is mature for the analysis of the primary endpoint as defined in the protocol
    3.The database has been fully cleaned and frozen for this analysis
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After progression, the treatment will be left to the discretion of the treating physician.

    Patients discontinuing treatment for reasons other than progression should not receive any other cancer treatment before their disease progresses, unless this is clearly not in the interest of the patient.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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