Previously untreated patients with asymptomatic chronic lymphocytic leukemia but who are at high risk of progression. MedDRA version: 18.1 Level: LLT Classification code 10060576 Term: Chronic lymphoid leukemia System Organ Class: 100000004864
Conditions
Interventions
Product Name: Depletin
Pharmaceutical Form: Oral liquid
INN or Proposed INN: Deuterium depleted water (DDW)
Current Sponsor code: EMA/SME/098/12/R2
Other descriptive name: DEUTERIUM DEPLETED WATER (
Sponsors
HYD Pharma Zrt.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written and signed informed consent according to local guidelines. 2. Male and female subjects >= 18 years of age. 3. Body weight = 6 months. 8. Adequate liver function as defined as: a. Serum (total) bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the efficacy of Depletin treatment in terms of clinical activity.;Secondary Objective: 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). ;Primary end point(s): The efficacy will be determined based on clinical activity as defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL).;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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. ;Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Slovakia
Contacts
Public ContactDr. László Nagy
Hungarotrial Zrt
Outcome results
None listed