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    Summary
    EudraCT Number:2015-003820-30
    Sponsor's Protocol Code Number:HYD-HD85/45-CLL-02
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-11-30
    Trial 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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2015-003820-30
    A.3Full title of the trial
    A MULTICENTER, SINGLE ARM, OPEN LABEL, EXPLORATORY PROSPECTIVE PHASE II STUDY TO EXPLORE THE EFFICACY, SAFETY AND TOLERABILITY OF DEUTERIUM DEPLETED WATER IN PREVIOUSLY UNTREATED PATIENTS WITH ASYMPTOMATIC CHRONIC LYMPHOCYTIC LEUKEMIA BUT WHO ARE AT HIGH RISK OF PROGRESSION.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A CLINICAL STUDY TO EXPLORE THE EFFICACY, SAFETY AND TOLERABILITY OF DEUTERIUM DEPLETED WATER IN PREVIOUSLY UNTREATED PATIENTS WITH ASYMPTOMATIC CHRONIC LYMPHOCYTIC LEUKEMIA.
    A.4.1Sponsor's protocol code numberHYD-HD85/45-CLL-02
    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 SponsorHYD Pharma Zrt.
    B.1.3.4CountryHungary
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHYD Pharma Zrt.
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHungarotrial Zrt
    B.5.2Functional name of contact pointDr. László Nagy
    B.5.3 Address:
    B.5.3.1Street AddressFehérvári út 89-95.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1119
    B.5.3.4CountryHungary
    B.5.4Telephone number3612032134
    B.5.5Fax number3612033985
    B.5.6E-maillnagy@hungarotrial.com
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDepletin
    D.3.4Pharmaceutical form Oral liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDeuterium depleted water (DDW)
    D.3.9.2Current sponsor codeEMA/SME/098/12/R2
    D.3.9.3Other descriptive nameDEUTERIUM DEPLETED WATER (DDW)
    D.3.9.4EV Substance CodeSUB180074
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number45 ppm to 85 ppm
    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
    Previously untreated patients with asymptomatic chronic lymphocytic leukemia but who are at high risk of progression.
    E.1.1.1Medical condition in easily understood language
    Previously untreated patients with asymptomatic chronic lymphocytic leukemia but who are at high risk of progression.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10060576
    E.1.2Term Chronic lymphoid leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore the efficacy of Depletin treatment in terms of clinical activity.
    E.2.2Secondary objectives of the trial
    To explore the safety and tolerability of Depletin treatment.
    To explore the deuterium concentration in patients.
    To explore the biological response of Depletin treatment in patients.
    To explore the pharmacodynamics of Depletin treatment.
    To explore the median time to first treatment (TTFT).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written and signed informed consent according to local guidelines.
    2. Male and female subjects >= 18 years of age.
    3. Body weight <= 90 kg.
    4. Histopathologically confirmed diagnosis of asymptomatic early stage CLL (Binet A) who are at high risk of progression (≥ 2 risk factors).
    5. No previous treatment for asymptomatic early stage CLL (Binet A).
    6. ECOG performance status <= 2.
    7. Life expectancy >= 6 months.
    8. Adequate liver function as defined as:
    a. Serum (total) bilirubin <= 2 x the upper limit of normal (ULN)
    b. Aspartate aminotransferase (ASAT) or serum glutamic oxaloacetic transaminase (SGOT) <= 2,5 x ULN
    c. Alanine aminotransferase (ALAT) or serum glutamic-pyruvix transaminase (SGPT) <= 2,5 x ULN
    d. Alkaline phosphatase (AP) <= 2,5 x ULN
    9. Adequate renal function as defined as:
    a. Serum creatinine <= 1.5 ULN

    b. Aspartate aminotransferase (ASAT) or serum glutamic oxaloacetic transaminase (SGOT) <= 2,5 x ULN
    c. Alanine aminotransferase (ALAT) or serum glutamic-pyruvix transaminase (SGPT) <= 2,5 x ULN
    d. Alkaline phosphatase (AP) <= 2,5 x ULN
    9. Adequate renal function as defined as:
    a. Serum creatinine <= 1.5 ULN
    E.4Principal exclusion criteria
    1. Subjects currently consuming or who have already consumed DDW.
    2. History of other malignancy, other than non-basal-cell carcinoma of the skin or in situ carcinoma of the cervix unless the tumor was treated with curative intent at least 2 years previously which could affect the diagnosis or assessment of CLL.
    3. Subjects with any of the following concurrent conditions:
    • Evidence or history of significant cardiovascular, endocrine or metabolic disease
    • Unstable angina pectoris, uncontrolled arrhythmia and cardiac insufficiency (NYHA Class III-IV).
    • Serious intercurrent medical conditions that may interfere with the planned treatment (including human immunodeficiency virus (HIV)-positive, serious active infection, central nervous system (CNS) disease, psychiatric illness.) Patient with active infections requiring systemic antibiotics should be excluded from the study until resolution of infection.
    • Clinically significant hepatic or renal disease.
    • Evidence or history of alcohol-, drug and/or medical abuse.
    • Other severe, concurrent disease(s) or mental disorder.
    4. Subjects who have been hospitalized, had surgery with full recovery or have received emergency treatment in the 4 weeks prior to the start of the study.
    5. Subjects currently receiving other investigational medication or who have received investigational medication in the month prior to the screening of the study.
    6. Subjects who are unlikely to be compliant or attend scheduled clinic visits and follow up as required or who are unlikely to be compliant with the recommendations of the protocol, in particular subjects who undertake regular sporting or above average physical activity.
    7. Employees of the Sponsor or the contract research organization (CRO) responsible for the execution of the study.
    8. For female patients of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) and male patients who are not surgically sterile or with female partners of childbearing potential: absence of effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel).
    9. Pregnancy or lactation (female patients). Serum pregnancy test to be performed within 7 days prior to study treatment start.
    10. Subjects who keep a strict vegetarian diet.
    E.5 End points
    E.5.1Primary end point(s)
    The efficacy will be determined based on clinical activity as defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    •The safety and tolerability will be determined based on the incidence of Adverse drug reactions (ADR) and serious ADRs, changes in hematology and chemistry values, including those associated with hepatic and renal function, and assessment of physical examinations, weight, Eastern Cooperative Oncology Group (ECOG) performance status, vital signs and cardiac function (i.e. repeated electrocardiograms).
    •Effects of Depletin on deuterium concentration in patients.
    •Effects of Depletin on and biologic response as defined by reduction in the absolute lymphocyte count of > 20% from the pretreatment level that was sustained for at least 2 months or a ≥ 30% reduction in all palpable lymphadenopathy.
    •Effects of Depletin on biomarkers CD5, CD19, CD20, CD23, CD38, thymidine kinase and beta-2-microglobulin.
    •Effect of Depletin on median TTFT defined as the time from study entry until the start of the next treatment due to objective disease progression or active disease.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 No
    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
    August 2017
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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: 21
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 No
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 25
    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)
    Those patients will receive this treatment whose medical condition does not require chemotherapy. As soon as patient's condition reach the level when chemotherapy is needed, she/he will be withdrawn from the study and receive the necessary treatment.
    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 Decision2016-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-11
    P. End of Trial
    P.End of Trial StatusOngoing
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